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efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
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family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
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initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
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The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
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V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
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emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
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Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
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family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
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initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
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Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
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Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
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in institutionaldevelopment in the area of research and evaluation of
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family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
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initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
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Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
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The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
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V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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quty of research stu4445 o4d service activities~undertaken and th OOetto hl the resu2ts of these are incororted IntCSor~e~
decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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-
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efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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T~oUtortiol444talty YortUtlit Reercro ram is a nonprofit 4or-Ioorgraed w~rthe l~aws or thPonloa 3tao or North Carolina with
hadquarters la theItM Nrth Carolina oerned2oarA iange Park ZtQs g01 a ttoalw lar or Directors wth members from bh devloped ad devloeping coutries (SeeApendi A)
on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
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The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
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V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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quty of research stu4445 o4d service activities~undertaken and th OOetto hl the resu2ts of these are incororted IntCSor~e~
decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
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emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
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Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
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family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
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initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
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Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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Re1erprogvras as wellPa~~added eprience4Infet~lity~reerhAn
efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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varityo s The benefi1ts ileculu n~s to ampLDCe4~ training a$ exp9144Q with the newest Ptnracptive toaholpsyt7 imetus to service
Re1erprogvras as wellPa~~added eprience4Infet~lity~reerhAn
efforts on the problems itpoor women in4 rural areas The shi44 of emphashysis from cU4linca trilsI ctracet Qptive mthod3 to evaluation and4 Im5provement oftheq delivery of availableservices is idicative ofthe Importance given to the problems of providing adequate health~ and familyplanning services to the rural poor
For~ the firszt year or the pr posed project$ funding is planned for the con- ~ tinued support o~f five rnativQiaI fertility research programs The amount of funding varies from country to country and is typically suffticient to cover a smallamount of core pogrs-a 3upport and administrative costs plus alarger reqsearch and program udget Funding is also planned to enable ZFRP to ontinue to provide technical zaitance services to national fertilityrsearchi programs Such assistance includes help with research1 designproblems data analy31$ and ccmputer processing as well as with the adminshyistratizn and-management of pr-ram operations
It is expected that fertility researcbh programs in other countries will re IFIZ support Groups in 7hailand Korea the Philipshyquest in the future
~spines Malaysia Egypt Nigi1a and Singapore have expressed interest in forming national fertility research programs Thus the proposed projectSallows for additional fundlng for -grams In subsequent years It Is alsogt
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
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riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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- 13 shy
those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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-15 shy
in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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was foun44 44 1975 iait study or at representatv~ae Qt$Or41V~iIn 10~re~~t hospitals thogi the country Data prcesiganUay-r~sis wa perrom4 14 logota Othertt amp s tudohich haeosieaberoe va oeO9 the faypanning program In ColombI4arebeing conductedtbAQ40 poundtu_ 5 AWQvor or thirty oQntr~botors Among th to_t im~portat of
ths 9~4S the postpartum Lad areo =U r barrier contrceptive
An impotant apect oflV is th xpressed desire or other Ltin AmericancQuE4ris to partici4pate Incompartive research studies by sending data to aoa for processing and analysis The potential for regional data pro
cosingAnd a rgonal approach~ totu4Jee 1Ls of equal Importance to PI 4Qcc-pients inColombia RIF wil~l likely double its number of studiesby inolUding investigators fr other Latin American countries~ in ts rhsearch network Among the min actities~to be sutpported throuh theIF7P CIrant are an analysis Of eap chil1dbearin2g and a continuation oftudiei of the p rvsion of contraceptive srvices and maternity care byhospita tZhrougoutthe country
The Badam Kerja Saina Penelitian Fertiltas Indonesia (313 PENFZI) theCoodintiii Board of IndoneiQ~an ertilitv Research is a nucleus for a
nainaetiiyresearch prga I nonsa This organization hasbee-roistred and established as an auto gqsnetworkc of twelve rhsearchers wrho are responsible for planning and implementing poicy obise-Stives The BKS ENVIN maintains Close liaison with the Gover~ueat of
4IndoneiW4 Family Planing~6 Coordbinating Bor (BM)
Itris envisioned that an increasing amount or the fertility research doneIn Indonesia Willrbe conducted by the 313 PENFIN IFRP has been requestedto suOrp the development of BKS PENFIN and to assist the Government ofIndonetzia n achieving its goal of population growth reduction ~ USAIJakatias expresd anpinter rest7 Lw utilizing thi vast experienceaccumilated in~I~iot on ol~contractption (there are currently over
five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
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initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
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The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
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V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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five million women on orals) to study various issues related to oral conshy
traceptive use LFRP tas developed research protocols which will be useful
in this endeavor This is the first time AID will support a national fershy
tility research program in Lndonesia and extensive technical assistance to
the Indonesian program will be required
IFRP iz assisting the government if Sri Lanka at the formal request of the
Ministry of Plan Implementation The Fertility Research Progrsmme of Sri
Lanka (PRSL) has been registered and establisned as a nonprofit
charitable organizatior It is composed of a network of thirteen
physician-researihers and a small administrative staff The IFRP has
assisted in the organization of FRFSL as a national fertility research
prcgram but extensive technical assistance from IFRP will be required for
some tLme
One of the studies being considered by the FRPSL is an island-wide trial
of postpartum IUD2 developed by the IF1P Because of the limited use of
the IUD this program promises to have considerable importance for family
planning activities in the country Additional studies being discussedshy
include one involving the provision of oral contraceptives ty traditional
practitioners
In the Sudan as in most of Africa there is the problem of how to bring
about an increased awareness of fertility control amidst of the widespread
desire for large families The approach used by the Sudan Fertility Conshy
trol Azsociation (SFCA) which was established in 1975 has been to conduct
a study of incomplete abortions and delivery outcomes Through this exershy
cise research experience was gained and the need for fertility control
became increasingly evident As a resutt there has been a marked shift in
interest among obstetricians and gyrecologists towards research in this
area At present the SFCA has sixty three mimbers most of whom are physhy
sicians Through association with IFRP one X diasertation has been
completed and several others are in progress These studies have helped to
bring attention to the problems of rapid population growth and the limited
availability of contraceptives Increased provision of family planning
services--developed because of these studies--are expected to begin this
year IFRP aas trained a Data Collection Coordinator for the Sudan Fertil
ity Control Association
to
assist eff)rts to coordinate research in fertility regulation and to con-Further development of the Sudan Fertility Control Association is needed
duct appropriate training projects Research and training will be carried
out through a network of Khartoum University and governmental hospitals
which are already actively involved in SFCA activities
In addition t its work in countries that have already established national fertility research programs ZFRP is requesting support for activities to be carried out in countries without existing national fertility research
programs The IFRP was officially invited by the Government of Mexico to provide technical assistance to the Mexican Biomedical Research rogram in its efforts to conduct studies on various contraceptive techniques Special data collection forms to study sterilization activities were designed by the IFRP The IFRP also supplied sterilization equipment and comouter proshy
grams to the Ministry of Public Health in Mexico Future activities in
-8shy
riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
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initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
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The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
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V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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riexico will center around the countrys growing sterilization and postparshytum IUD program in addition IFRP is discussing the possibility of becoming involved in IUD program evaluation in Mexico
C International Federation of Family Health Research
The International Federation of Family Health Research which was organizedin November 1977 as the International Federation of Fertility Research Proshygramme provides a forum for the exchange of information and ideas amongnational fertility research programs and helps coordinate the work of indishyvidual country programs As such it enhances the work nationalof each program and provides a means for the research results to become more widelyknown and utilized by LDC institutions active in the provision of contrashyceptive services Because the Federation has been organized and is led bypeople from the developing world it has a credibility with LDC administrashytors and policy makers which more westernized groups do not The Federation therefore plays a significant role in encouraging the formashytion of fertility research programs in additional LDCs Support for the Federation will help that organization
1 encourage national fertility research programs in countries such as Bangladesh Colombia Egypt India Indonesia Korea The Philshyippines Singapore Sri Lanka Sudan Thailand Nigeria Singaporeand Malaysia
2 develop guidelines for the formulation and implementation of fam-Ily planning welfare and health programs and policies at commushynity and national levels in the above countries as well as at the international level
3 establish standard design analysis and reporting procedures for basic and applied fertility research
4 serve as a resource providing advice on safe effective and desirshyable family planning services to governmental and nongovernmental groups
5 provide a centralized forum for the exchange of ideas and experishyence to ensure rapid dissemination of information on fertility control technology
Previous IFRP support has helped the Federation move toward achieving itsgoals An AID supported meeting of the Federation was held in April 1978 at which time common interests and plans for future research and service activities were discussed Several important papers were prepared bymeeting participants The Federations leaders developed plans for raisingfunds from non-AID sources and visited several potential donors It is anticipated that this type of activity will eventually lead to selfshysufficiency for the Federation and ultimately for national fertilityresearch programs
In the eFederation and has assisted in the formulation of studydesigns aided in
data processing and in the design of data collection instruments and helpedwith analysis of data These activities are expected to continue but with
-9shy
emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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emphasis on the work being shifted to national programs The IFRP will continue to serve as a coordinator of comparative analysis of projects conshyducted by members of the Federaion Support for the IFRPs assistance to the International Federation of Family Health Research is needed to ensure its continued growth
The Federation is currently seeking funding from several other groups including European donors church groups and the United Nations Fund for Population Activities It is anticipated that these fund-raising efforts will be successful Thus the proposed project provides for a diminishing amount of AID support for the Federation
AID funding will be used to support those activities that individual national programs are unable to support such as international meetings of the Federations members support of the Federations Secretariat and work by the members aimed at increasing the awareness and involvement of nonmemshyber country institutions in the program of the Federation Major research and programmatic activities by individual national fertility research proshygrams will not be supported by the Federation Additional non-AID funding may however be used by the Federation to make grants to individual memshybers For the FY 79 it is expected that IFRP support will represent the overwhelming majority of funding available to the Federation By FY 81 IFRP support is expected to represent approximately 50 of the Federations annual budget
D Provision of Monitoring Services
The provision of monitoring services to LDC family planning programs is a second strategy of the proposed project Adequate information on family planning services maternity care and the utilization of abortion is essenshytial for program management and thus for the improvement and increase of services
aternity Care Studies The single sheet Mit rnity Record designed by the IFRP and endorsed by the International Federation of Gynaecology and Obstetrics is in widespread use in hospitals throughout the developed and developing world Maternity Record data are currently being collected in 62 hospitals A good deal of preliminary analysis has been completed The results thus far available clearly demonstrate the value of this record for LDC hospital administrators family planning program personnel and scienshytific researchers The Maternity Record has proven to be important in monshyitoring the quality of care and providing insight into the management of difficult deliveries in hospitals in developing countries This in turn provides insights into how to improve maternity care
Several papers using this data base have been prepared and presented or submitted for publication Plans are currently underway to analyze Matershynity Record data to investigate questions related to teenage childbearingThe IFRP believes that it is important to continue to introduce the Record into developing countries which have special needs to improve maternityservices and at the same time to continue to collect sufficient high quality data to answer research questions whi are of great concern to medical practitioners and policy makers as well as clients throughout the world The benefit of the Maternity Record extends beyond a particular
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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34
willbe introduced into smaller rural hospitals indeveloping cuntria3 This~ isespecially important becauise in~many COUntries doctors in largeurban medical JGntemsare well acquaizntedwith thIe problems of-abortionwile their coQoaeasin rural areas are 1ess certain of its extent sershyousnes3 and conequences Earlier work on the Maternity Record and hospi tal abortion studies was suppgrted through Contract AMD pha-C-1 172
Rea rd Systems anid Prgvalfnce Suryvs- Funds are also requested to assist LD~ with developmenft 44ofrcord 3ystems-and the-conduict of contraceptiveprevalence surveys Such record systems and surveys describe what contrashyqepive pepl prsnl nwadue43suh hypo lvlali4(formation frprogram planners and policy makers The pr 6 wr wl be concentrated in atin America and Africa As a result ot this proposed
3 project activity
a data will be obtained o contraceptive seb method and suc Of service
3b accessibility of co~traceptiie services will be determined inshyterms of relationship [to contraceptive acceptance and use
co data on fertility levels and other measures of health status~will be obtained and
d socioeconomic characteristics of users and nonusers will~be examshyined
For tte early stages of the Grant emphasis will be placed on maternity care studies and secondarily on contraceptive prevalence surveys and
YDelivery System Evaluation 3Stpport is also requested to assist developinigco9untries in evaluating contraceptivedelivery systems3 4
witDSPOPRZ7 asistanceLSr currentlyInvolved in the evaituation~of specialized delivery systemsgt in Sri Lanka33 K~K~
- 11 -
Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
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- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
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33
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Tunisia and Morocco The goal of each of these projects is to make contrashyceptive deg-rvices more widely available The projects involve usingparamedic or nonmedical personnel to deliver contraceptive services prinshycipally orals and condoms to women in their homes Such projects have been very successful in many countries Acceptance rates have increased dramatically continuation has been favorable and fertility has been decreased
In Morocco an extensive Household Distribution Program as been initiated Li the province of Marrakech By July M38 IFRP had data on approximately30000 cases in this program with revisit analysis on both acceptors ana nonacceptors in successive phases of the project
At AIDs request the Marrakech ousehold Diitribution Project in Morocco was developed with the assistance of IFRP by the Moroccoan Ministry of Health Department of Family Planning The objectives of the project are to
a extend family planning services to approximately 200000 houseshyholds
b measure contraceptive prevalence within the study population
c measure the number of children desired by the couples within the study population
d develop techniques and training for management supervision and progr-am evaluation which may be suitable for application throughshyout the Kingdom of Morocco
The project in Tunisia has been under way since 1976 when AID was invited by the Otfice National de Planning Familial et de la Population (ONPFP) of Tunisia to initiate a pilot household distribution program of contraceptiveservice delivery in a rural area in the southern part of the country Elishygible women in the project area numbering approximately 5000 out of a total population of nearly 40000 individuals were interviewed about their fertility and contraceptive histories and offered OCs at the initial homevisit Up to five revisits at intervrals of from four to six months are designed to motivate nonacceptors to use OCs and to measure the continuashytilon rate among women who had accepted at a previous visit A final surveyis scheduled for September 1978 and will measure contraceptive _nowledgeattitudes and pratices as well as fertility levels at the close of the two-year campaign One indicator of program success will be ths increase in the number of contraceptors--partl ularly those utilizing programOCs--by comparing initial baseline survey results with those to be colshylected at he final home visit
E Phase IV Clinical Trials
An additional strategy of the project for which support is requested is theintroduction of proven methods in LDCs where they are not in use Phase IV trials of proven methods can serve as a means of diffusing existing contrashyceptive technology to ong-ing programs This activity i-s one of the most cost-effective ways to introduce new technology into LDCs Typically theIFRP supports the work of one of is collaborating investigators on the
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
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The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
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V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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-15 shy
in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
- 16 shy
well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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those countries in which the IFRP is providing active support This will ensure that Pertizent 4- -ma-n ia th are as f cntracepticn an- fertilshyity control will be available to LDC policy makers practitioners amd proshygram administrators Emphasis will be placed on distribution to members of the IFRF research network and to participants in the various national fershytility researct programs
The proposed project also includes support for a limited number of scienshytific or professional conferences to be held in LDC3 when these are considered likely to have a major impact on the population family or health programs of a particular country or region During the first year of the project FRP plans limited support for the Pan-1slamic Conferences on othertood in Cairo The conference promises to provide an important forum for the di3cuzsion of a number of issues of concern to AID and IFRP Conferences such as this one can be an extremely useful means of increasing awareness of the impact of excess fertility and rapid population growth among the most influential segments of national and international communities
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
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family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
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initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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SI hIG IANTS Di rect [FRP Overhead
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98436 3840
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-
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-15 shy
in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
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+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
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family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
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initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
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The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
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V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
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SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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in part to population increase but rapid population growth contributes to the increasing difficulty of feeding the human population Comparable effects also can be traced on efforts to improve the living standards of people in rapidly growing countries
If a nation has an economic growth rate of 5 a year and a population growth rate of 35 a year it is only realizing a net gain of 1 12 per year in raising the standard of living The objectives of all development programs are curtailed as long as population growth rates approach increases in GNP Until national population ograms begin to yield sigshynificant declines in population growth rates there will be a constant dampening effect on all other AID developmental programs As an example until population growth in rural areas is slowed and increasing pressure on existing land lessened rural displacement and over-urbanization will continue to hinder social and economic development
The benefits to society of lowering population growth have been discussed in a macro context by Coale and Hoover and in a micro context by Enke For a more recent discussion of the benefits of reducing population growth see PM Hauser in Rapid Population Growth
The precise economic benefits of Family Planning programs are difficult to quantify The long debate beginning with the work of Enke and continuing through Leibenstein Simon and others makes it clear that the widely recogshynized benefits of reduced population growth are not easy to measure We must therefore choose the least costly way of obtaining these important benefits
Several studies have indicated clearly that the provision of an increased number of contraceptive methods and a wide variety of delivery systems are extremely efficient ways to increase contraceptive acceptance and use and thus lower fertility
II SOCIAL SOUNDNESS
A Contextualization
Political religious economic and cultural factors frequently are signifishycant barriers to the diffusion of contraceptive methods family planning programs and research results The issue is sharpened when the diffusion is from developed nations (including the US) to LDCs Old passions and antagonisms are rekindled when family 7lanning technology is the substance of such diffusion
Under a prev ous Grant to the 1FRP (AIDpha-G-1198) a significant breakshythrough was obtained in that family planning technology transfer was de-emoticnalized Six LDC fertility research programs composed of and led by 1F7P contributors joined to create the International Federation of Famshyily Health Research The Federation is now sharing experiences learned ir individual research programs and with 12RP support taking the initiatie in encouraging the formation of additional national and regional fertility research programs The work of the Federation maximizes the spread effect of the latest fertility research This effect is significant because it presents an opportunity for elite urban North American or Western Euroshypean oriented LDC scientists and physicians to work for the increased
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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hadquarters la theItM Nrth Carolina oerned2oarA iange Park ZtQs g01 a ttoalw lar or Directors wth members from bh devloped ad devloeping coutries (SeeApendi A)
on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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SI hIG IANTS Di rect [FRP Overhead
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well-being of the economically disadvantaged members of their own socieshyties Ti many instances involvement in biomedical research of the type to be supported under the project is the first step toward the recognition on the part of elite t-ember3 of LDC societies that 2_aprovements in tne quality and availability of health and family planning services are basic human rights
Frequently LDC scientists enjoy international prominence in their research areas However their work has little or no impact in their own countries because LDCs typically lack the structures needed to adapt technological and scientific developments for local use or resist initiating programs which may threaten their quality scientists and encourage them to emigrate The proposed project works within the framework of the existing social structure by providing a mechanism for elite scientists to have a direct impact on the welfare of their fellow citizens without challenging their traditional position or encouraging them to contribute to the brain drain
B The Role of Women
The initiation or acceleration of a decline i- fertility and population growth rates is the primary goal of the proposed project The means used in reaohing this goal requires the involvement of women The participation of women improves both the acceptability and legitimacy of all project activities because working with women is more likely to be successful than doing work for them The human rights aspect of this approach deserves emphasis The key concept _1s the right o choose Choosing a social role or the size of one~s family requires both legitimate equality and reproducshytive freedom
The proposed project is concerned with two interrelated issues involving the role of women 1) -he development of services which are more sensitive and responsive to the needs and concerns of women and 2) the integration of women into managerial and decision making positions in national programs Much of I Ps past work and many of the activities planned under this proshyject are aimed at improving the status of women All IFR training proshygrams provide an opportunity for women health workers to improve their skills Key staff of each of the national fertility research prTgrams are women RP also puts special emphasis on working with womens groups As an example projects are currently being conducted in collaboration wih Concerned Women of Bangladesh and the School of Nursing at the Catholic University in Sao Paulo Brazil These specialized activities are in addishytion to FRPs regular program which by definition aims to improve the well-being of Dmen The Maternity Care Monitoring System described earlier is an especially good example of a program that tas had an immediate and positive impact on women In LDCs
C Communication Strategies
A significant problem for medical specialists in LDCs is keeping informed of current developments in their field The proposed project will provide support for the publication of the nternatiornal Journal of lynaecolozv 2nd Obstetr~cl which Provides articles on topics of international interest including the research results of many authors working wit support from AID To maximize the distribution of this Journal funds will be used to offset publication and distribution costs so that subscriptions can be
- 17 shy
oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
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34509
10300
105347
2527
22587
23914
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oifered at an attractive local price in LDCs Subscribers from developednations will be charged a higner at cost subscription rate Support will also be provided for training programs and conferences aimed at increasing the ability of LDC health personnel to provide needed serviices
D Private Sector involvement
Private institutions and organizations in several LDCs have been and are being organized to conduct fertility control related research In many countries governments are not yet prepared to support these activities but do not objecs to their performance through nongovernment agencies In other instances national fertility research programs are quasigovernmental organizations enjoying government sanction of their activities Efforts will continue to gain private sector and host country government support for these organizations
An important zonsequence of this private sector involvement is that it presents fertiLiy research and family planning program evaluation as an acceptable local practice It puts population studies into the local culturalpopular language and helps break down traditional barriers to the scientific exploration of fertility behavior
One important by-product of these efforts is the observation by governmentsthat fertility research is accepted by the scientific community the prishyvate sector and the public This in turn leads to increased involvement by governments in these activities
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T~oUtortiol444talty YortUtlit Reercro ram is a nonprofit 4or-Ioorgraed w~rthe l~aws or thPonloa 3tao or North Carolina with
hadquarters la theItM Nrth Carolina oerned2oarA iange Park ZtQs g01 a ttoalw lar or Directors wth members from bh devloped ad devloeping coutries (SeeApendi A)
on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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quty of research stu4445 o4d service activities~undertaken and th OOetto hl the resu2ts of these are incororted IntCSor~e~
decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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SI hIG IANTS Di rect [FRP Overhead
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98436 3840
20I992 38401
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-
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T~oUtortiol444talty YortUtlit Reercro ram is a nonprofit 4or-Ioorgraed w~rthe l~aws or thPonloa 3tao or North Carolina with
hadquarters la theItM Nrth Carolina oerned2oarA iange Park ZtQs g01 a ttoalw lar or Directors wth members from bh devloped ad devloeping coutries (SeeApendi A)
on11 ed 1 1971 with support from Contraqt LMcsd 2979 t th 4iVrsit ofr Wrth Carolina at hap l ill nF wsinitialy desgnedwlsr4 to condut fildtrials or now developments infertility ontrilUttr three years 4 develo pedanetwork or clnial tril4 centers had boo and Ver 40nduoung a IUzo duber of asg4es that extended beyond thUaodtlte Utorest or the Uiversty On February 14 195 by mutua Sagremet f A WIFI and e Universityl the UIPassumed responsibilityfor lotac AIDos4 29T9 as a private nonprofit eirga4ntzat4on
T M~ netioric of coibutng ~o11teOr and indivdualcontributors conshystiutis a important segment or Lnf2uentiail eadership for family planni~ng
progmsa througg the -less 4iveopod world UP contributors areonago4 laamp Cotnuu diaogu i~ plusmnth the ZFRl headquarers~~~~~~~~i- tPILThis ledU~~ toa
+I [O +91 V++ P+a -~~)idensttiiation embers of the netwiork4 Z++aamong which ++then led tothe delepment of a number of nation~al fertility research programs and tothe organiatio Of the laternatlocal eder ation of Family Health Research inNoveber 19T7 The coordiation of these national programs and other
- 0UUl44 rwlations t~o LDC gvernmen~ts have led requ3t3 for shy
- -assistance
in institutionaldevelopment in the area of research and evaluation of
- 19 shy
family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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SI hIG IANTS Di rect [FRP Overhead
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-
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family planning programs Many requests have been received for assistance in studying new developments in fertility control to documeut the safetyeffectiveness and acceptability of a variety of family planning methods in particular LDC cultural settings and in training for the introduction of new technology in family planning pro -ams Such requests have been directed to the IFRP because much of the research methodology used by existing national fertility research programs has teen developed by IFP as part of its program of work supported by AID research contracts Moreover under its AID research contracts IFRP has documented the advantages of many of the family planning methods which are of interest to national programs IFRP has shortened the time from the development to the utilization of improved methods of fertility control in LDCs by providing assistance in the development of research and evaluation capabilities by guiding field studies of new methods of fertility control and by providing training for the introduction of these methods This result has been enhanced by the fact that IFRP contributors serve on advisory committees to LDC governshyments and most contributor centers also are responsible for service proshygrams providing contraception Several thousand service clinics extend from the IFRP research network and they provide the critical mass of expeshyrience necessary for the rapid introduction of new methods of fertility control in LDCs IFRPs relationship with collaborating LDC investigators is excellent The dropout rate among contributing centers has been extremely low This attests to IFRP responsiveness to LDC needs
Recognizing the potential of the IFRP support of LDC programs AID provided Grant AiDpha-G-1198 on September 30 1977 for $655208 This proposal is for a fcllow-on to that Grant azid to program development and research inishytiated under Contract AIDcad 2979 and Contract AIDpha-C-1172
To assess the ultimate impact of IFRPs past activity in reducing unwanted fertility and contributing to increases in economic development heqlth the status of women and the general quality of life is a subjective task Nevertheless FRP has made a number of clearly significant contributions
A Under AID sponsorship IFRP has demonstrated
1 the comparative safety efficacy and acceptability of different outpatient tubal occlusion techniques for female sterilizaticn in LDCs
2 the safety efficacy and acceptability of menstrual regulation and later first trimester abortion in LDCs
3 the relative safety and effectiveness of various procedures for female sterilization
4 the acceptability of vasectomy in a Latin American setting
5 the competence of nurses to perform menstrual regulation
6 the effectiveness of copper-containing IUDs for up to six years of use
7 that a simple modification to existing IUDs can improve retention in postpartum insertions and
8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
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$28387
34509
10300
105347
2527
22587
23914
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5 10923
13279
3963
40538
9728
B692
9203
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$101598
150072
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31279
33117
$65
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8 the symptoms associated with different oral contraceptives and symptoms associated with crossover to another oral contracepshytive
While lFRPs predominant activity has been Phase ill clinical trials the activities for which support is requested flow directly from tne~is activishyties When IFRP is recruiting a new contributor the usual practice is to begin with fairly simple straight studies These studies often have treshymendous impact locally It may be the first time for that particular counshytry that the acceptability efficacy and safety of a particular procedure has been demonstrated The political salience of experience derived from ones own country should not be underestimated Similarly IFRPs researcki protocols include studies of maternity cases and the consequences of incomshyplete (illegally induced) abortions The number of requests for these studies has increased markedly over the last year
In addition to providing direct information relating to better health care delivery these studies can be used to empnasize the health benefits of family planning Again having local data makes the case much stronger Another programmatic spinoff from IFRPs AID supported contract research relates to the Phase III clinical trials Once a useful new contraceptive technique is developed IFRPs network of contributors facilitates worldwide dissemination In part this occurs because many of the contribshyutors will have participated in developing the technique and are typically leaders in their respective communities Additionally strong relationshyships and personal contacts in numerous countries mak for a rapid dissemishynation of information and expertise A case in point has been the use of the tubal ring for laparoscopic sterilization Thus the proposed grant activities represent a natural evolution of IRPs contract
IFRP handles many aspects of its research as a self-contained unit These Include design of study protocols design of data collection forms coordination of data collection computer processing of data analysis graphic arts and editorial support presentation and publication After careful cost-effectiveness consideration IFRP has decided to perform these functions in-house Thus unlike many US based service organizations which basically serve as a conduit for funding IFRP is involved in a large amount of direct work Personnel levels ar thus relatively high but overshyall costs are low RPs overhead rate is lower than that of universities and other direct work organizations
B Relationships with Other Organizations
FRP has the only large scale aetwork conducting international comparative clinical studies in LDCs and it must interact closely with a numter of AiD-sponsored research projects as well as with major populationfamily planning organizations IF-RP has developed an excellent working relationshyship with organizations such as ARFR IEGO the opulation Council and various university groups The exchange with AVS and FIA has also been cordial and mutually beneficial Collaboration continues between IFRP and Battelle as well as between FRP and the Southwest Foundation
7R has established a unique relationship with the Internatlonai Fedoration of Gynaecology and Obstetrics (FIGO) This relationship was
- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
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Direct~
$28387
34509
10300
105347
2527
22587
23914
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5 10923
13279
3963
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9728
B692
9203
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150072
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- 21 shy
initiated with cooperative production of the International Journal 2f Gynshyaecology amp Obstetrics (IJGO)-which is now the offizial publication of both FIGO and the IFRP The relattonship has n-w extended to joint sponsorshipof an international study of the IFRPs Maternity Record There is considshyerable potential for further cooperative work with FIGO FIGO has a memshybership of over 35000 ostetriciangynecologists many of whom work in developing countries FiGOs Standing Committee on Medical Aspects of Human Reproduction has taken considerable interest in research service and training and desires to work cooperatively with IFRP in these areas
]FRPs relationship with PIACT has been strengthened since PIACTS growinginvolvemenr in contraceptive acceptability trials Open and continual dla logue with all key organizations in the field including pharmaceuticalcompanies is maintained In an effort to maximize IFRPs effectiveness and minimize any overlap in activities
Dissemination of information is an integral part of the IFRPs work because the organization recognizes that research findings must be giventhe widest distribution possible Over the past year IFRPs capability to produce and disseminate scientific publications has been significantlystrengthened With the installation of new text processing and typesetting equipment IFRP prepares some 100 papers a year for presentation at national regional and international conferences Many of these are pubshylished in scientIfic journals A number of the publications are prepared as a service to contributors although the direct involvement of IFRP staff In this activity is expected to diminish in the future
C Management
The International Fertility Research Program has a well balanced management team with many years of experience working for international populationagencies The Executive Director is a public health physician from Chile with many years experience in health administration The core of IFRPs International Activities Department is composed of four physicians all from developing countries and all with considerable international experishyence in population family planning and related health work Three of the four are women Each has a deep commitment to Lmproving the status of women and their role in the development process
The Special Projects Department formed in April 1978 provides a focal point for the technical and scientific aspects of IFRPs international proshygrammatic activities The Department also has a special interest in the dissemination of the results of its research For this reason many ofIFRFPs information dissemination activitIes have been centralized within the Special Projects Department
The Department is composed of fourteen people Four staff members two of whom are women hold doctorates in the social sciences Five other memshybers three of whom are women hold masters degrees in public health or social science Members of the Special Projects Department have ad extenshysive overseas experience Staff members have worked in government or prishyvate health family planning or population programs in the followingcountries Korea Thailand Philippines Taiwan Sri Lanka Indonesia India Tunisia Morocco Brazil Malawi Zaire Micronesia and the Caribshybean
-- n7-
Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
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150072
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Staff of 1FRPs Research and Administrative Departments will also provide support for project activities The Research Department has been the principal architect of the protocols data collection instruments and analshyysis plans used by the national fertility research programs and other researchers
E requires the same administrative rigor in national fertility programs as they do to their own US research operation This assures not only high quality and timely research results but also a low administrative cost for these programs Under the proposed project the only funds that will go to the IFRP will be for support services directly related to one of
the subgrants
The IFRP has demonstrated consistent managerial skill in the selection of local networks to become indigenous fertility research programs This has resulted not only in the selection of recognized leaders in the medical communities of LDCs but also in well managed and administered programs progressing toward self-sufficiency
D Evaluations of IFRP
Recent evaluations of IFRP by AIDs Research Advisory Committee and by research staff of the Office of Population have concluded that IFRP plays an extremely important role in international family planning work and that its program of activities meets vital needs of both LDCs and AID which no other organization is now capable of meeting
The Office of Population evaluation conducted in September 1977 noted that IRP has developed unique international capability to carry out Phase III testing of fertility regulation methods and has effectively carried out this function The evaluation also noted that IFRP has made objectively identifiable contributions to the population field which have been valuable from programmatic and policy viewpoints and has in-house capabilities that are unusual in research organizations allowing for effishycient data processing analysis and dissemination of findings The evalshyuation team reported that IFRPs productivity and efficiency have seemed to increase over the years as measured by the amount of research activishyties undertaken compared to staff and funds The team concluded that IFRP is an impressive organization with a strong record of accomplishshymerits
A similar conclusion was reached by the Research Advisory Committee Subcomshymittee evaluating IFRP Their report noted that the IFRP is a very ambitious and hard working group The immediate purpose of its contract has been accomplIshedThe outreach capability of the ZFRP into develshyoping countries is extensive and still growing IRPs potentialb are significant
Wnile the focus of the evaluation conducted by the Subcommittee of the AID Research Advisory Committee was IFRPs performance under AID contracts it also touched upon the activIties for which funding is requested here
This term defines the phase in the evaluation of a procedure product or device when it is undergoing widescale testing under cdnditions similar to those of its ultimate ordinary pattorn of use
- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
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$28387
34509
10300
105347
2527
22587
23914
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5 10923
13279
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- 23 -
The RAC Subcommittee report states in-part
As a by-product of the data collecton effort FRP has helped a number of developing country institutions toestablish their own data processing capabilities Itis now providing technical support for several programsthat show promise of developing autonomous capabiltty indata collection and analysis This institution buildingfunction though not research in itself is an importantpre-condition to the conduct of good research
The Research Advisory Committee recently recommended that 1FRPs researchcontract be extended for three years However activities of the typedescribed in this proposal were judged ineligible for support under thecontract Because of their importance IFRP is requesting that theseactivities be funded by a Sperific Support Grant As the Research AdvisoryCommittee notes there is a very close link between IFRPs grant and conshytract work This interdependency provides IFRP with a unique capability to carry out the proposed program of work
The primary focus of IFRP assistance will continue to be on increasing theability of LDC institutions to evaluate fertility control technology andmonitoring family planning and maternity care services Increasing theavailability of the latest contraceptive technology and providing the meansfor evaluating its use are critically important particularly where LDC resources for such activities are carce or nonexistent mprovements intechnology and delivery systemshave been crucial for the success of LDCfamily planning programs in the past This will continue to be the casefor the imediate future Thus the proposed IFRP project represents pershyhaps the most influential avenue of intervention open to slow the rap ld population growth of LDCs
The proposed four year budget is bazed on what should be done and what IFIcan do during the project period Since the budgets of project subgrant3sare individually reviewed and fiscal year budgets are reviewed annuallychanges will be made based upon evaluation of the performance of LDC instishytutions
- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
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ININ
IIP
33
333
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133
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- 24 -
V FINANCIAL PLAN (see appended proposed Budget)
A Financial Rate of ReturnViability
Because this project is not a revenue-producing activity an analysis of financial rate of return or financial viability of the subgrants has iotbeen made The project does have an anticipated (though difficult to measshyure) economic impact via its role in decreasing excess fertility and popushylation growth The positive economic effects of decreased fertility arerealized at the individual and family level especially for mothers and children as well as by cumulative effect at the national and global level
B Recurrent Budget Analysis
he project budget is considered adequate to fLnd the recurrent operatingand maintenance costs assumed by IFRP in conducting this project BecauseIFP possesses particular skills in project identification and support but lacks the financial resources needed to carry out these tasks its internashytional activities will be almost wholly supported funds AID Conshyby frcn tracts and Grants IFRP would not be able to continue its involvement in this field at the same level of activity in the absence of AID or other support The purpose of this project is not institution building or resource development at IFRP but rather the development and expansion of contraceptive and family planning research and service programs in LDCs Consequently eventual development of a self-sustaining non-AID fundedfinancially viable IFRP backstopping program to national FRPs is not an objective of this project Current nongovernment resource availabilities for population research particularly Phase II clinical trials are not adequate to sustain the necessary level of activity by 27RP and other international assistance agencies i-n the population field
This project does not therefore include a phase-ouL schedule or estishyan mation of iFRP gradual assumption of project costs IFRP is seeking other donors to expand its activity beyond that described herein but these other-donor funds are not realistically expected to amount to more than 10 of FRP budgets for international programs during tne next four years
C Previous AID Funding
AID funding for FRP commenced on February 15 1975 the date 17RP began tofunction as an independent organization under Contract AIDcsd-C-2979Prior to that date IFR research activities were funded under the same conshytract as part of AID support at the University of North Carolina A Novashytion Agreement assigned the AID Contract to the newly formed privatenonprcf Corporation 7R FundLng has been continued Contractsunder Dpha-C-1111 AIDpha-C-1172 and AIDpna-C-1191
Grant support to FRP for the type of activities outlined in this proposal was initiated with Grant ADpha-G-1198 n September 1977 Table 1 detailsbudget expenditures f r FRP and subgrants still active under that Grant agreement as of May 1979
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
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10Q data to o roportsO -by theIi ~~ ~ ut9v -rR 97
Whe TIJ reqest subpoas be relvt gr qxtead for 4A44104 poi~ tt will~ cogxualt to AU~ V~rrwt4Ir~y oot34ie$ th
U$V ro th Pt444 or renewal mquost 44M rvo4 aiart orksol Piotfcat~n o suDrao will re~4re AZD ppv-shy
obectve o the rT)posed prijoot Such smo89~ 4140 OoY4oo It accordance with 914$ ~ an an oown polcie rcdua Sum = the sax9 manner as otto~pQ~oso4 awlx4u
All proJqct will have the uw~tio Cocrrenc or A=~ prior to rJa4
FR will b rsponsl~l for montoing all subantap~ proved O4 iml medwthi -he rpsdIrjtr hs-al nl j o
t4o assistnc~ as may be necessary tpr each $ubgrante 0 achieve hs Iner upose and tbjdtives Such assistan~ce 4vil tormaly to --vIded throug the regulart ra~ortift and atre AA~mocanim acrb in eac subrat agreemen and through site visits by aprpriate~M staf do
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tLstsFor t ftoro neces say and rrsedain ft4 AZ ctp
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or thepocs Izpact Inth srtq rnoLiewsetto zpoaltoo Muto expect~o a~ct~vtt ampaL~otate diret flsosubsapoec to harve4
mos appoprate evlato crteiThe9)$ ar rlatetoinases Inth =0610(ot4ae 1v zothod 4vllbl fsor~ as an the sp atwhiC
Iovement In4~ etility cntro sra QLa2avUpQ method ttoL
rv ostn ippjrt sppt MuaJo4 rte ito rier~a incud th2Oe nube ad
quty of research stu4445 o4d service activities~undertaken and th OOetto hl the resu2ts of these are incororted IntCSor~e~
decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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TAiBIE I
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LIFRI
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Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
Lm
3lt
iiI
i
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3 3
Wto
I o
TABLE 3
International Fertility Research Program Proposed Budget
Salaries
Fringe benefits
ul-av- 1
rpI=iilneIL
SIipp] ies
Data processing
Other direct
Subgrants
Overhead
FY 70
$ 200
42
15
-0-
15
184
15
850
285
11606
($000)
FY 79
$ 218
46
5
-0-
20
216
15
970
325
$1835
FY 00
$ 238
50
25
-0-
20
237
15
1085
357
$2027
FY 8i Total
$ 260 $ 916
60 198
65 130
39 39
30 85
265 902
25 70
1170 4075
401 1368
$2315 $7783
lool PiMASO MW bolt Mt IsuWA w M~v14W
LAl sniteen MYv4 tums Mt4 404-OU UM tt A
4jMI t Tbo At On~t~lf vampk 44 n1t4 at Opfluttu
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ftuv1 sra tle~
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or thepocs Izpact Inth srtq rnoLiewsetto zpoaltoo Muto expect~o a~ct~vtt ampaL~otate diret flsosubsapoec to harve4
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quty of research stu4445 o4d service activities~undertaken and th OOetto hl the resu2ts of these are incororted IntCSor~e~
decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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jo~1P~Mgh O e thttgt Il 1 ch etty declineu~sRUtt94a extent tofctors9 0110ft904r$0 =Y4 9949rfl04Q th4leve hasi 1r4e4
or thepocs Izpact Inth srtq rnoLiewsetto zpoaltoo Muto expect~o a~ct~vtt ampaL~otate diret flsosubsapoec to harve4
mos appoprate evlato crteiThe9)$ ar rlatetoinases Inth =0610(ot4ae 1v zothod 4vllbl fsor~ as an the sp atwhiC
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rv ostn ippjrt sppt MuaJo4 rte ito rier~a incud th2Oe nube ad
quty of research stu4445 o4d service activities~undertaken and th OOetto hl the resu2ts of these are incororted IntCSor~e~
decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
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decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
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quty of research stu4445 o4d service activities~undertaken and th OOetto hl the resu2ts of these are incororted IntCSor~e~
decision makingi Pnesses
APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
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40538
9728
B692
9203
TOTAI
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APPENDIX A
INTERNATIONAL F RTILITY RESEARCH PROGRAM
WOARD OF DECTOR
Elton Kessel MD MPH - Chairperson President hternatic-nal Fertility Research ProgramResearch Triangle Park NC 27709
Sharon Lee Camp PhD Policy Anal ystPopulation Crisis Committee Suite 550 1120 19th Street NW Washington DC 20026
Donald A Collins MA President Donald A Collins Assoctates 111 Pine Street 18th Floor San Francisco California 94411
Mrs Guadalupe de La 7ega Planificacion Familiar de CD Juarbz AC Avenida Carlos Amaya y Cartagena Ciudad Juarez Chihuahua Mexico Mailing Address P 0 Box 10096 E1 Paso Texas 73991
Hubert de Wattev-l I MD Prfessor La Cilnique de Gynecologie et DObstetrique 5 rue Charles - Bonnet CH 1206 Geneva Switzerland
T H Lean FRACS FRCS(G) FRCOG Consulting Specialist Obstetrics amp Gynecolog CNIC 323 Suite 202-20a (2nd Floor) Malayan Credit House 916 Somerset Road Singapore 9 Republic of Singapore
Malcob ots MYD PhD DROOG Consultant nternat-nal anned Parenthood Federation Mfailing Ades 8Langbourne Avenue London N5 6AL England
CORPORATE OFFICERS
Elton Kessel MD MPH President
Hubert de Watteviil- Mn Professor Vice President
Malcolm PotPts DRCOG
Secretary
M MD PhD
James Allen aw
Jr Attorney-at-
Assistant Secretary
Donald A Collins SA Treasurer
EXECUTIVE COMMITTE
Elton Kesse- MD MPH
Donald A Collins MBA
Malcolm Potts MB MD hDDRCCG
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
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rpsarn in= and evaluation of-onmlc development Pruesase Vid
r9Mizrszjo after n~atural or anragao disaszarl
a)Jcr swial 4eytjcn gr-ole
f) fr ra ra f -4ran omnt
~~ eisteir t m
7le 2tra Ccu24r8 A
C107vy tau
FASec amp11 )
or art1 Iamptaud
11ja V
w 4o
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FAA See 110ai ~ Wll~ ram oec
ain $4nfc ryf~t3 pvgri44Ma4o fffgr3Cfo O uI1amppoiM1a04Ai
ephsPlison1trqemn
1 frrl~nubnor
of Avoc~crcoomicPo~tlialandby mat1tin EQ$ (lecuoy s fneip (3)
imniq avaunbily f nd worker
Cb4 in he ovn~ry ()ptrqAns lesigne tewMWgth ountrys heltol
n~c(5)ot-or moatrant arus 0~
7 ment including incuszry fret labor unions c~pnle ind Vglunt3ryAgenciejs imsoru~on an~d cOAIInlcSAshytion planning and uolic Aaminstration
~~ur~an develonmn and modernization of axisting laws r (6) intagritlng women intz ne ruc1ent countrys national
SAASec 23lIbl OescribeexInt to ____________ra rt0qzs ~ ati rPr
-
~uus~ds~vsnac~ac~is ~o~M~Proj
=ountrvs 1rta~itcjai resourtts
a~ suCDor5sivie tucaz1onand rsnin z
1 css ss san tat osel -goverlfwmnt~
J
enabling them to cease childbeaing at desired number of childrenl
oP r projfct purpose and
luplevientatlon4 ext7aisively utilizes
host dntry resources aamp
-- - ---- -shy
-
2
~
~~5~ ~ ~
www~itxwit We oeloftnvV
IRS Will I ontribm U F90114011 sio rov1V4 ff 1 inj ~sfei
Iurr ofi 1-4~Ton 45ifc 0 OOMW
of-eYmentsCion
dvelopment Assistanes Prilict Criteria
a FAA Sec4 ZO11b)(1) Informationand ocu~n~v1ai1f finan img from otleqi iq-worle sCrss4 nClUd1ng rivatssa ra wttflin USK
vaio0n ana zniuson on4) I ~f
reasonaclentss of ripaym1ent rospotsInc (2)evasonablqe and 1 i
enclng Inc relendjng a~rm of vh loan2 -
Utm ursuant to a tuti1amptsrj p1anIa tle aniounc of 4hi loan axceWs S000 has~czunty SLuomited to AMI an IoC IICai an 9or SU f~flS tZ90th4r2wi rassurances 4~nlca t0a funds
i a uset iin acnmi311ly ampIC2 MiicallC3y sound n
Kn2 I
-shy
23crioi now I -mote~amp
icunt-t untry$ wian and----~ a r8p-Lbs1 s irr i aMents Iao ~ ~
ne ro4ampSI--efum~nac1vs-- -shy mo I C21p511-5i~~~~II e el 1~~5$-0enwic tr5~V51~-
I~
-
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11 1 fI w w l
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yMoi own1 vtm
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4IM-111~~-r Z01
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in of 4 to o u 1rtm-o 1O4p
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too~ tprgFAA6~ Apo~ Iso WWIf R ttI4
App fn t S A
4 $I41tolA~gt Rio molin 0 ageeIR~rO 4mo$
f IW~A1
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finnce S ll to MRSW$It on p rivtl
s4 fai u g atls 4n
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11 A0 t xt 1- 4--14
4 4ca 4 mlo - ul Am 4 ftivt - ft~rz zm4 4 4 4 - shy
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W unuo7)vit wis~o7uI
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COASIN-WO74--9 Oof Mn
0t4
Vov oR~fasitac 1p14 not~ oxclo
FAA SoMoI
toE00 Nr-e V $44 million77
0PIvUr P6iA
doeCosat 1suaelra ae A$i
brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
t-11 bstflPutsts if th US
7
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vil an fauVu4si t
4 f~ fif i V e fa 7
aA ts 1 m fo 11~49 WOI ~
FA Cg pj4PA It RIIMwlOw o
FAA for A Too
ror 11111oRR I111y fty
fWff-ss-A wu U1mmwt0 o
Am ~~ ~ ~ Ulct Im ~51 ~ - Ivesfo
P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
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33
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I o
APPENDIX 3
INTERNATIONAL ERILITY RvESEARCH PROGRAM
MANAGEMENT AND SCIENTFC STAFF
OFFICE OP THE vESUDENT
President Elton Kessel MD MPHDirector of Field Epidemiology Roger Bernard MD MSPM
OFFICE OF THE EXECUTVE DIRECTOR
Executive Director Alfredo Goldsmith MD MPHMedical Director Leonard Laufe MDBioeng -neer Robert Wheeler MetE
INTERNATIONAL ACTIVITIES DEPARTENT
Associate Director for International Activities
Chief Pan America Regional Coordinator Regional Coordinator Chief Far East
J1 Peng M-D DPH MSPM Vacant Christine Colven Betsy Taylor Pouruchis Shiwandiwalla DGO
Regional Coordinator Regional Coordinator Chief Europe Africa amp
DFP ML FCPS Thomas Hardy Nasiha Ahmad MD
Middle East Regional Coordinator Regional Coordinator
Vacant Khairia Vacan
Cmran MD MPH DrPH
RESEARCHDEARTT
Associate Director for Research David Edelman MS PhDEpidemiol9gis-t I-cheng Chi i WH DrPHResearch Group Leader Stephen Mumford MPH DrPHSenior Research Analyst Lynda Cole MAResearch na1yst Rhona Kantor MPHResearch Grouo Leader Mrgaret McCann MSResearcn Associate Lngr4d Swenson RN MPH DrHResearcn Associate tIan Batar MDSenior Research nalyst Robert Taylor MPHPublicat-ons Manager Patricia McCart-hyrograing Manager Karen Ulberg
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
IMV
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of snlttnl fliq teR iy
(4)~5fo 9 r 4MIical asstsunce
mnt tseclalIy wVi US rivaug sectM4~ volunty jr ri1i1fi1 aIntr
(b) Itl flU~f robirn allviate
rpsarn in= and evaluation of-onmlc development Pruesase Vid
r9Mizrszjo after n~atural or anragao disaszarl
a)Jcr swial 4eytjcn gr-ole
f) fr ra ra f -4ran omnt
~~ eisteir t m
7le 2tra Ccu24r8 A
C107vy tau
FASec amp11 )
or art1 Iamptaud
11ja V
w 4o
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FAA See 110ai ~ Wll~ ram oec
ain $4nfc ryf~t3 pvgri44Ma4o fffgr3Cfo O uI1amppoiM1a04Ai
ephsPlison1trqemn
1 frrl~nubnor
of Avoc~crcoomicPo~tlialandby mat1tin EQ$ (lecuoy s fneip (3)
imniq avaunbily f nd worker
Cb4 in he ovn~ry ()ptrqAns lesigne tewMWgth ountrys heltol
n~c(5)ot-or moatrant arus 0~
7 ment including incuszry fret labor unions c~pnle ind Vglunt3ryAgenciejs imsoru~on an~d cOAIInlcSAshytion planning and uolic Aaminstration
~~ur~an develonmn and modernization of axisting laws r (6) intagritlng women intz ne ruc1ent countrys national
SAASec 23lIbl OescribeexInt to ____________ra rt0qzs ~ ati rPr
-
~uus~ds~vsnac~ac~is ~o~M~Proj
=ountrvs 1rta~itcjai resourtts
a~ suCDor5sivie tucaz1onand rsnin z
1 css ss san tat osel -goverlfwmnt~
J
enabling them to cease childbeaing at desired number of childrenl
oP r projfct purpose and
luplevientatlon4 ext7aisively utilizes
host dntry resources aamp
-- - ---- -shy
-
2
~
~~5~ ~ ~
www~itxwit We oeloftnvV
IRS Will I ontribm U F90114011 sio rov1V4 ff 1 inj ~sfei
Iurr ofi 1-4~Ton 45ifc 0 OOMW
of-eYmentsCion
dvelopment Assistanes Prilict Criteria
a FAA Sec4 ZO11b)(1) Informationand ocu~n~v1ai1f finan img from otleqi iq-worle sCrss4 nClUd1ng rivatssa ra wttflin USK
vaio0n ana zniuson on4) I ~f
reasonaclentss of ripaym1ent rospotsInc (2)evasonablqe and 1 i
enclng Inc relendjng a~rm of vh loan2 -
Utm ursuant to a tuti1amptsrj p1anIa tle aniounc of 4hi loan axceWs S000 has~czunty SLuomited to AMI an IoC IICai an 9or SU f~flS tZ90th4r2wi rassurances 4~nlca t0a funds
i a uset iin acnmi311ly ampIC2 MiicallC3y sound n
Kn2 I
-shy
23crioi now I -mote~amp
icunt-t untry$ wian and----~ a r8p-Lbs1 s irr i aMents Iao ~ ~
ne ro4ampSI--efum~nac1vs-- -shy mo I C21p511-5i~~~~II e el 1~~5$-0enwic tr5~V51~-
I~
-
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447jox~i ~ V4o -o
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11 1 fI w w l
1
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yMoi own1 vtm
At I
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App fn t S A
4 $I41tolA~gt Rio molin 0 ageeIR~rO 4mo$
f IW~A1
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finnce S ll to MRSW$It on p rivtl
s4 fai u g atls 4n
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11 A0 t xt 1- 4--14
4 4ca 4 mlo - ul Am 4 ftivt - ft~rz zm4 4 4 4 - shy
-A7 LI
W unuo7)vit wis~o7uI
M~4 tt41W 4o a -shy 7o
COASIN-WO74--9 Oof Mn
0t4
Vov oR~fasitac 1p14 not~ oxclo
FAA SoMoI
toE00 Nr-e V $44 million77
0PIvUr P6iA
doeCosat 1suaelra ae A$i
brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
t-11 bstflPutsts if th US
7
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vil an fauVu4si t
4 f~ fif i V e fa 7
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FAA for A Too
ror 11111oRR I111y fty
fWff-ss-A wu U1mmwt0 o
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P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
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iiI
i
-
3 3
Wto
I o
Appendix 3
-2-
SPEVCAL PROJECTS DEPART ENT
Associate Director for Special Projects Peter Donaldson MA PhD
Project Officer Charles Ausnerman MDiv MSPH PhD
Speci4al Projects Group Leader Judith Fortney MS PhD Project Analyst Douglas Nichols YA Project Analyst Karen Stewart MSH Project Analys Catherine Cameron MSPH Special Projects Group Leader Barbara Janowitz PhD Project Analyst Sharon Bode MSPH Information Coordinator William Barrows CS
ADMINI5TRATIVE DEPARTMNT
Associate Director for AdmListration Gaines Turner
Contracts Administrator Curtis Swezy MPH DrPH Administ rat ive Servicez Manager Margaret Morrow Financial Services Manager alter Parris CPA Personnel Services Manager Elizabeth Schultz Cmputer Center Manager Christopher Whitener Pext Processing Manager Lorene Williford Manager JGO Mary Derr
-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
IMV
41
h +++
Jf +
+J
~~
~~
itI
ljftjff I
+11+
I l+
ff1j+
11
118 40
a
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+++ +
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II
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4~
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BLE D9WMENTOR
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vi ou~ iru i$ tiu R $Ivt~322A
T4ampQ Fit J Wlshy
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i 14cor 4nru 4tonsio 4z w lt i i--ten44OM f -
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4401vitlo-astilft wons rat
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OvelopeeV4qif whtsfIc
iiC1 rM6Mtsni 1)
of snlttnl fliq teR iy
(4)~5fo 9 r 4MIical asstsunce
mnt tseclalIy wVi US rivaug sectM4~ volunty jr ri1i1fi1 aIntr
(b) Itl flU~f robirn allviate
rpsarn in= and evaluation of-onmlc development Pruesase Vid
r9Mizrszjo after n~atural or anragao disaszarl
a)Jcr swial 4eytjcn gr-ole
f) fr ra ra f -4ran omnt
~~ eisteir t m
7le 2tra Ccu24r8 A
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or art1 Iamptaud
11ja V
w 4o
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ain $4nfc ryf~t3 pvgri44Ma4o fffgr3Cfo O uI1amppoiM1a04Ai
ephsPlison1trqemn
1 frrl~nubnor
of Avoc~crcoomicPo~tlialandby mat1tin EQ$ (lecuoy s fneip (3)
imniq avaunbily f nd worker
Cb4 in he ovn~ry ()ptrqAns lesigne tewMWgth ountrys heltol
n~c(5)ot-or moatrant arus 0~
7 ment including incuszry fret labor unions c~pnle ind Vglunt3ryAgenciejs imsoru~on an~d cOAIInlcSAshytion planning and uolic Aaminstration
~~ur~an develonmn and modernization of axisting laws r (6) intagritlng women intz ne ruc1ent countrys national
SAASec 23lIbl OescribeexInt to ____________ra rt0qzs ~ ati rPr
-
~uus~ds~vsnac~ac~is ~o~M~Proj
=ountrvs 1rta~itcjai resourtts
a~ suCDor5sivie tucaz1onand rsnin z
1 css ss san tat osel -goverlfwmnt~
J
enabling them to cease childbeaing at desired number of childrenl
oP r projfct purpose and
luplevientatlon4 ext7aisively utilizes
host dntry resources aamp
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-
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~
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IRS Will I ontribm U F90114011 sio rov1V4 ff 1 inj ~sfei
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vaio0n ana zniuson on4) I ~f
reasonaclentss of ripaym1ent rospotsInc (2)evasonablqe and 1 i
enclng Inc relendjng a~rm of vh loan2 -
Utm ursuant to a tuti1amptsrj p1anIa tle aniounc of 4hi loan axceWs S000 has~czunty SLuomited to AMI an IoC IICai an 9or SU f~flS tZ90th4r2wi rassurances 4~nlca t0a funds
i a uset iin acnmi311ly ampIC2 MiicallC3y sound n
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ne ro4ampSI--efum~nac1vs-- -shy mo I C21p511-5i~~~~II e el 1~~5$-0enwic tr5~V51~-
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f IW~A1
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finnce S ll to MRSW$It on p rivtl
s4 fai u g atls 4n
7tZ-AC f t asst n - 4 it 4-s wil asitneOs ay 4-u- s z
11 A0 t xt 1- 4--14
4 4ca 4 mlo - ul Am 4 ftivt - ft~rz zm4 4 4 4 - shy
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W unuo7)vit wis~o7uI
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COASIN-WO74--9 Oof Mn
0t4
Vov oR~fasitac 1p14 not~ oxclo
FAA SoMoI
toE00 Nr-e V $44 million77
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t-11 bstflPutsts if th US
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4 f~ fif i V e fa 7
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ror 11111oRR I111y fty
fWff-ss-A wu U1mmwt0 o
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P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
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okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
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-1-
APPENDIX C
ENVIRONMENTAL THRESHOLD DETERMINATION
TO AADS Sander M Levin THRU DSPO R Simpson
FROM DSPOP R T Ravenholt
SUBJECT Environmental Threshold Determination
Project Title International Fertility Research Program Project 932-0537 Specific Activity (if applicable) REFERENCE Initial EnvironmentalExamination (IEE) contained in
attached paper dated
I recommend that you make the following determination
I not a major Federal1 The proposed agency action is action which will have a significant effect on the human environment
2 The proposed agency action is a major Federal action which will have a significant effect on the human environment and
a An Environmental Assessment is required or
b An Environmental Impact Statement is required
The cost of and schedule for this requirement is fully described in the referenced document
3 Our environmental examination is not complete We will submit the analysis no later than vith our recommendation for an environmental threshold decision
Approved
Disapproved
Date
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
IMV
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of snlttnl fliq teR iy
(4)~5fo 9 r 4MIical asstsunce
mnt tseclalIy wVi US rivaug sectM4~ volunty jr ri1i1fi1 aIntr
(b) Itl flU~f robirn allviate
rpsarn in= and evaluation of-onmlc development Pruesase Vid
r9Mizrszjo after n~atural or anragao disaszarl
a)Jcr swial 4eytjcn gr-ole
f) fr ra ra f -4ran omnt
~~ eisteir t m
7le 2tra Ccu24r8 A
C107vy tau
FASec amp11 )
or art1 Iamptaud
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ain $4nfc ryf~t3 pvgri44Ma4o fffgr3Cfo O uI1amppoiM1a04Ai
ephsPlison1trqemn
1 frrl~nubnor
of Avoc~crcoomicPo~tlialandby mat1tin EQ$ (lecuoy s fneip (3)
imniq avaunbily f nd worker
Cb4 in he ovn~ry ()ptrqAns lesigne tewMWgth ountrys heltol
n~c(5)ot-or moatrant arus 0~
7 ment including incuszry fret labor unions c~pnle ind Vglunt3ryAgenciejs imsoru~on an~d cOAIInlcSAshytion planning and uolic Aaminstration
~~ur~an develonmn and modernization of axisting laws r (6) intagritlng women intz ne ruc1ent countrys national
SAASec 23lIbl OescribeexInt to ____________ra rt0qzs ~ ati rPr
-
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a~ suCDor5sivie tucaz1onand rsnin z
1 css ss san tat osel -goverlfwmnt~
J
enabling them to cease childbeaing at desired number of childrenl
oP r projfct purpose and
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host dntry resources aamp
-- - ---- -shy
-
2
~
~~5~ ~ ~
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IRS Will I ontribm U F90114011 sio rov1V4 ff 1 inj ~sfei
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a FAA Sec4 ZO11b)(1) Informationand ocu~n~v1ai1f finan img from otleqi iq-worle sCrss4 nClUd1ng rivatssa ra wttflin USK
vaio0n ana zniuson on4) I ~f
reasonaclentss of ripaym1ent rospotsInc (2)evasonablqe and 1 i
enclng Inc relendjng a~rm of vh loan2 -
Utm ursuant to a tuti1amptsrj p1anIa tle aniounc of 4hi loan axceWs S000 has~czunty SLuomited to AMI an IoC IICai an 9or SU f~flS tZ90th4r2wi rassurances 4~nlca t0a funds
i a uset iin acnmi311ly ampIC2 MiicallC3y sound n
Kn2 I
-shy
23crioi now I -mote~amp
icunt-t untry$ wian and----~ a r8p-Lbs1 s irr i aMents Iao ~ ~
ne ro4ampSI--efum~nac1vs-- -shy mo I C21p511-5i~~~~II e el 1~~5$-0enwic tr5~V51~-
I~
-
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447jox~i ~ V4o -o
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11 1 fI w w l
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1 I5 4 A ot
MhMUS)tIU i ~m 9nolol~ WR4s4twt r~~~1 WilW14 of Ummo
yMoi own1 vtm
At I
4IM-111~~-r Z01
i
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4alw4 a ffi - ronmls 1 O
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too~ tprgFAA6~ Apo~ Iso WWIf R ttI4
App fn t S A
4 $I41tolA~gt Rio molin 0 ageeIR~rO 4mo$
f IW~A1
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c~11IR41 with ~~ ~ w9$1o f
finnce S ll to MRSW$It on p rivtl
s4 fai u g atls 4n
7tZ-AC f t asst n - 4 it 4-s wil asitneOs ay 4-u- s z
11 A0 t xt 1- 4--14
4 4ca 4 mlo - ul Am 4 ftivt - ft~rz zm4 4 4 4 - shy
-A7 LI
W unuo7)vit wis~o7uI
M~4 tt41W 4o a -shy 7o
COASIN-WO74--9 Oof Mn
0t4
Vov oR~fasitac 1p14 not~ oxclo
FAA SoMoI
toE00 Nr-e V $44 million77
0PIvUr P6iA
doeCosat 1suaelra ae A$i
brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
t-11 bstflPutsts if th US
7
mo~q ~~77o
vil an fauVu4si t
4 f~ fif i V e fa 7
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ror 11111oRR I111y fty
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TAiBIE I
1IROWleI
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P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
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3lt
iiI
i
-
3 3
Wto
I o
Appendix C
-2-
IMPACT IDENTIICATION AND EVALUATION FORM
2 1 2acI=act Areas amp Sub-reas- tmactz tnac Areas amp Sub-areas-
A LANL LSE F SCCIOECCNOMIC 1 Cbanging the character of the 1 Change$ in economicemployne=
land thr oat ns N--
a Increain the population N 2 Cbanges in population N
b Extracting natural resources N 3 Changes in cultural patterns N
c Land clearing N 4 Other factors
d Changing soil character N
2 Altering natural defenses N G HEALTH 1 Cbanging a natural environment N
3 Foreclosing important uses N 2 Elim nating an ecosystem elemqnC N
4 Jeopardizing man or his works N 3 Other factors
5Other factors
H GENERAL B WATER QUALITY 1 International impacts
1 Physical state of water N 2 Controversial impa e N
2 Chemical and biological states N 3 Larger program impacts N
3 Ecological balance N -
4 Other factors 4 Other factors
L OTHER POSSIBLE IPACTS (not listed above) C ATMCSPHERIC
1 Air additives N
2 Nispollution N
3 Noise pollution N ____________
4 Other factors FOOTNOTES
-__ I See E=-la=at T Notes for this form
D NATURAL RESOURCES 2 Use the following symbols 1 Diversion altered use ofwater N
N- No environmental impact 2 Irreversilhe unemcient c mitews N L-Little eavironxental impact
M- Moderate environmental impact3 Other factors_________ H- Hig environmental impact
U- Unknown environmental impact
Additional comments M CULTURAL
1 Utering p hsical symbols N
2 Dilution of cultural tradiions N
3 Other factors
IMV
41
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Jf +
+J
~~
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ljftjff I
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4401vitlo-astilft wons rat
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of snlttnl fliq teR iy
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mnt tseclalIy wVi US rivaug sectM4~ volunty jr ri1i1fi1 aIntr
(b) Itl flU~f robirn allviate
rpsarn in= and evaluation of-onmlc development Pruesase Vid
r9Mizrszjo after n~atural or anragao disaszarl
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~~ eisteir t m
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ain $4nfc ryf~t3 pvgri44Ma4o fffgr3Cfo O uI1amppoiM1a04Ai
ephsPlison1trqemn
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imniq avaunbily f nd worker
Cb4 in he ovn~ry ()ptrqAns lesigne tewMWgth ountrys heltol
n~c(5)ot-or moatrant arus 0~
7 ment including incuszry fret labor unions c~pnle ind Vglunt3ryAgenciejs imsoru~on an~d cOAIInlcSAshytion planning and uolic Aaminstration
~~ur~an develonmn and modernization of axisting laws r (6) intagritlng women intz ne ruc1ent countrys national
SAASec 23lIbl OescribeexInt to ____________ra rt0qzs ~ ati rPr
-
~uus~ds~vsnac~ac~is ~o~M~Proj
=ountrvs 1rta~itcjai resourtts
a~ suCDor5sivie tucaz1onand rsnin z
1 css ss san tat osel -goverlfwmnt~
J
enabling them to cease childbeaing at desired number of childrenl
oP r projfct purpose and
luplevientatlon4 ext7aisively utilizes
host dntry resources aamp
-- - ---- -shy
-
2
~
~~5~ ~ ~
www~itxwit We oeloftnvV
IRS Will I ontribm U F90114011 sio rov1V4 ff 1 inj ~sfei
Iurr ofi 1-4~Ton 45ifc 0 OOMW
of-eYmentsCion
dvelopment Assistanes Prilict Criteria
a FAA Sec4 ZO11b)(1) Informationand ocu~n~v1ai1f finan img from otleqi iq-worle sCrss4 nClUd1ng rivatssa ra wttflin USK
vaio0n ana zniuson on4) I ~f
reasonaclentss of ripaym1ent rospotsInc (2)evasonablqe and 1 i
enclng Inc relendjng a~rm of vh loan2 -
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ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
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$101598
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lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
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enabling them to cease childbeaing at desired number of childrenl
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~
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IRS Will I ontribm U F90114011 sio rov1V4 ff 1 inj ~sfei
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a FAA Sec4 ZO11b)(1) Informationand ocu~n~v1ai1f finan img from otleqi iq-worle sCrss4 nClUd1ng rivatssa ra wttflin USK
vaio0n ana zniuson on4) I ~f
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enclng Inc relendjng a~rm of vh loan2 -
Utm ursuant to a tuti1amptsrj p1anIa tle aniounc of 4hi loan axceWs S000 has~czunty SLuomited to AMI an IoC IICai an 9or SU f~flS tZ90th4r2wi rassurances 4~nlca t0a funds
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COASIN-WO74--9 Oof Mn
0t4
Vov oR~fasitac 1p14 not~ oxclo
FAA SoMoI
toE00 Nr-e V $44 million77
0PIvUr P6iA
doeCosat 1suaelra ae A$i
brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
t-11 bstflPutsts if th US
7
mo~q ~~77o
vil an fauVu4si t
4 f~ fif i V e fa 7
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FAA for A Too
ror 11111oRR I111y fty
fWff-ss-A wu U1mmwt0 o
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P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
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Lm
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i
-
3 3
Wto
I o
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UHVFIniegvfFA p4Son
n ntyi pii vos amprisionq toeMa p feas eentt i
so iv Of VnISt e 0trv isopfi
FAA ~ gjgjhe142n u Qb w$ QU$1P US jm
Ap eetw l s pf
nximw 4X14 0149uThe C4or se~Uii PwWOWq lou Ajflcio me4etaEQt1~L)e i41W 0
Of~4evcs Vt4 4 04t-
~~~~~ 1 evenpcmsscu risl Usta
o p6u~ip joo y m~loca- - i cca d vin No
74= 4XM~V
a~HP Sei etIqctSia Ill Soc 281a Ext i Z wSItncia
o s Jsenta -- wn ~ 7atvlin ir s raoor t~o et NA7i syv~ ace an localgrextendin ar eom
i 14cor 4nru 4tonsio 4z w lt i i--ten44OM f -
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mnt tseclalIy wVi US rivaug sectM4~ volunty jr ri1i1fi1 aIntr
(b) Itl flU~f robirn allviate
rpsarn in= and evaluation of-onmlc development Pruesase Vid
r9Mizrszjo after n~atural or anragao disaszarl
a)Jcr swial 4eytjcn gr-ole
f) fr ra ra f -4ran omnt
~~ eisteir t m
7le 2tra Ccu24r8 A
C107vy tau
FASec amp11 )
or art1 Iamptaud
11ja V
w 4o
r~vrtmnOat w~yfor ~4or 4~v
FAA See 110ai ~ Wll~ ram oec
ain $4nfc ryf~t3 pvgri44Ma4o fffgr3Cfo O uI1amppoiM1a04Ai
ephsPlison1trqemn
1 frrl~nubnor
of Avoc~crcoomicPo~tlialandby mat1tin EQ$ (lecuoy s fneip (3)
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vaio0n ana zniuson on4) I ~f
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lid esJILh l
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Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
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$101598
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enabling them to cease childbeaing at desired number of childrenl
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COASIN-WO74--9 Oof Mn
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toE00 Nr-e V $44 million77
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TAiBIE I
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lid esJILh l
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Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
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8 12]1
31279
33117
$65
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ain $4nfc ryf~t3 pvgri44Ma4o fffgr3Cfo O uI1amppoiM1a04Ai
ephsPlison1trqemn
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of Avoc~crcoomicPo~tlialandby mat1tin EQ$ (lecuoy s fneip (3)
imniq avaunbily f nd worker
Cb4 in he ovn~ry ()ptrqAns lesigne tewMWgth ountrys heltol
n~c(5)ot-or moatrant arus 0~
7 ment including incuszry fret labor unions c~pnle ind Vglunt3ryAgenciejs imsoru~on an~d cOAIInlcSAshytion planning and uolic Aaminstration
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SAASec 23lIbl OescribeexInt to ____________ra rt0qzs ~ ati rPr
-
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a~ suCDor5sivie tucaz1onand rsnin z
1 css ss san tat osel -goverlfwmnt~
J
enabling them to cease childbeaing at desired number of childrenl
oP r projfct purpose and
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host dntry resources aamp
-- - ---- -shy
-
2
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~~5~ ~ ~
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IRS Will I ontribm U F90114011 sio rov1V4 ff 1 inj ~sfei
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dvelopment Assistanes Prilict Criteria
a FAA Sec4 ZO11b)(1) Informationand ocu~n~v1ai1f finan img from otleqi iq-worle sCrss4 nClUd1ng rivatssa ra wttflin USK
vaio0n ana zniuson on4) I ~f
reasonaclentss of ripaym1ent rospotsInc (2)evasonablqe and 1 i
enclng Inc relendjng a~rm of vh loan2 -
Utm ursuant to a tuti1amptsrj p1anIa tle aniounc of 4hi loan axceWs S000 has~czunty SLuomited to AMI an IoC IICai an 9or SU f~flS tZ90th4r2wi rassurances 4~nlca t0a funds
i a uset iin acnmi311ly ampIC2 MiicallC3y sound n
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COASIN-WO74--9 Oof Mn
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toE00 Nr-e V $44 million77
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brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
t-11 bstflPutsts if th US
7
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TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
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a FAA Sec4 ZO11b)(1) Informationand ocu~n~v1ai1f finan img from otleqi iq-worle sCrss4 nClUd1ng rivatssa ra wttflin USK
vaio0n ana zniuson on4) I ~f
reasonaclentss of ripaym1ent rospotsInc (2)evasonablqe and 1 i
enclng Inc relendjng a~rm of vh loan2 -
Utm ursuant to a tuti1amptsrj p1anIa tle aniounc of 4hi loan axceWs S000 has~czunty SLuomited to AMI an IoC IICai an 9or SU f~flS tZ90th4r2wi rassurances 4~nlca t0a funds
i a uset iin acnmi311ly ampIC2 MiicallC3y sound n
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brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
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7
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P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
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yMoi own1 vtm
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4IM-111~~-r Z01
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f IW~A1
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7tZ-AC f t asst n - 4 it 4-s wil asitneOs ay 4-u- s z
11 A0 t xt 1- 4--14
4 4ca 4 mlo - ul Am 4 ftivt - ft~rz zm4 4 4 4 - shy
-A7 LI
W unuo7)vit wis~o7uI
M~4 tt41W 4o a -shy 7o
COASIN-WO74--9 Oof Mn
0t4
Vov oR~fasitac 1p14 not~ oxclo
FAA SoMoI
toE00 Nr-e V $44 million77
0PIvUr P6iA
doeCosat 1suaelra ae A$i
brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
t-11 bstflPutsts if th US
7
mo~q ~~77o
vil an fauVu4si t
4 f~ fif i V e fa 7
aA ts 1 m fo 11~49 WOI ~
FA Cg pj4PA It RIIMwlOw o
FAA for A Too
ror 11111oRR I111y fty
fWff-ss-A wu U1mmwt0 o
Am ~~ ~ ~ Ulct Im ~51 ~ - Ivesfo
P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
Lm
3lt
iiI
i
-
3 3
Wto
I o
i
Am4 ~ ~4~W
M O - i
in of 4 to o u 1rtm-o 1O4p
4alw4 a ffi - ronmls 1 O
IM Pt1A ro 4won 4il f()omi 0w lpq A
too~ tprgFAA6~ Apo~ Iso WWIf R ttI4
App fn t S A
4 $I41tolA~gt Rio molin 0 ageeIR~rO 4mo$
f IW~A1
4~~ ~ Pgt -f fiftore Orsure mom geos or-OfJIP0W1uro knalI t $fraan 1Mr
FUa Will 10_- e10
c~11IR41 with ~~ ~ w9$1o f
finnce S ll to MRSW$It on p rivtl
s4 fai u g atls 4n
7tZ-AC f t asst n - 4 it 4-s wil asitneOs ay 4-u- s z
11 A0 t xt 1- 4--14
4 4ca 4 mlo - ul Am 4 ftivt - ft~rz zm4 4 4 4 - shy
-A7 LI
W unuo7)vit wis~o7uI
M~4 tt41W 4o a -shy 7o
COASIN-WO74--9 Oof Mn
0t4
Vov oR~fasitac 1p14 not~ oxclo
FAA SoMoI
toE00 Nr-e V $44 million77
0PIvUr P6iA
doeCosat 1suaelra ae A$i
brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
t-11 bstflPutsts if th US
7
mo~q ~~77o
vil an fauVu4si t
4 f~ fif i V e fa 7
aA ts 1 m fo 11~49 WOI ~
FA Cg pj4PA It RIIMwlOw o
FAA for A Too
ror 11111oRR I111y fty
fWff-ss-A wu U1mmwt0 o
Am ~~ ~ ~ Ulct Im ~51 ~ - Ivesfo
P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
Lm
3lt
iiI
i
-
3 3
Wto
I o
-A7 LI
W unuo7)vit wis~o7uI
M~4 tt41W 4o a -shy 7o
COASIN-WO74--9 Oof Mn
0t4
Vov oR~fasitac 1p14 not~ oxclo
FAA SoMoI
toE00 Nr-e V $44 million77
0PIvUr P6iA
doeCosat 1suaelra ae A$i
brc~c AAIt or IssistDIngt Iforein ti onqat s or ia v e C~mwmst-il3 =uqr ivs trr -z
t-11 bstflPutsts if th US
7
mo~q ~~77o
vil an fauVu4si t
4 f~ fif i V e fa 7
aA ts 1 m fo 11~49 WOI ~
FA Cg pj4PA It RIIMwlOw o
FAA for A Too
ror 11111oRR I111y fty
fWff-ss-A wu U1mmwt0 o
Am ~~ ~ ~ Ulct Im ~51 ~ - Ivesfo
P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
Lm
3lt
iiI
i
-
3 3
Wto
I o
aA ts 1 m fo 11~49 WOI ~
FA Cg pj4PA It RIIMwlOw o
FAA for A Too
ror 11111oRR I111y fty
fWff-ss-A wu U1mmwt0 o
Am ~~ ~ ~ Ulct Im ~51 ~ - Ivesfo
P~~ ~~ pI01 a ~ 41praesI1imUS
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
Lm
3lt
iiI
i
-
3 3
Wto
I o
TAiBIE I
1IROWleI
He xico
P11R1
LIFRI
lid esJILh l
Sio [l i10 CultItyveE api I1rcva Iclce
Ttillisii F ProjecL
okrucco F Project
(lTiAI OlIiIGATIamp7 JS
ILIjII AM(mil ii O1 (I(ANT
LUNL()ii GAI) AIAINC-0
Internationtal Fertility Research Program
Seputiher 30 1971 - Sept-wber 29
SI hIG IANTS Di rect [FRP Overhead
S58440 $ 3848
98436 3840
20I992 38401
57184 3840
46269 3848
-
Subgrants
1978
Direct~
$28387
34509
10300
105347
2527
22587
23914
AID Grant 1198
I IuR IF14P Overhead
5 10923
13279
3963
40538
9728
B692
9203
TOTAI
$101598
150072
4710shy
20b 91
8 12]1
31279
33117
$65
6552to9
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
Lm
3lt
iiI
i
-
3 3
Wto
I o
W
ININ
IIP
33
333
3-
133
-
3~~~V
33
Lm
3lt
iiI
i
-
3 3
Wto
I o