using research to strengthen health systems and meet the needs of communities

A follow-up report from the Global Health

Council’s Research Symposium

on May 28, 2008 in Washington DC

Using Research to Strengthen Health Systems and Meet the Needs of Communities

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Using Research to Strengthen Health Systems and Meet the Needs of Communities

A follow-up report from the Global Health Council’s Research Symposiumon May 28, 2008 in Washington, DC

This report is based on the Research Symposium, Using Research to Strengthen Health Systems and Meet the Needs of Communities, at the Global Health Council’s 35th annual conference, held in Washington, DC on May 28, 2008. The Global Health Council (GHC) is very grateful to the speakers, discussion group facilitators, and advisors for their valuable contributions to the Symposium and to Jen Kim, Claire Tebbets and Rebecca Wolitz for their excellent notes from the sessions.

Thank you to Ahbay Bang, Jamie Guth, Jane Kengeya-Kayondo, and Catherine Peckham for envisions to the draft, and to Robert Eiss for his comments.

GHC would like to acknowledge The Fogarty International Center of the National Institutes of Health, The Heilbrunn Department of Population and Family Health in the Mailman School of Public Health at Columbia University, The Nuffi eld Council on Bioethics, and The Special Programme for Research and Training in Tropical Diseases for partnering with GHC on the Symposium. GHC is grateful for generous support from Bristol-Myers Squibb, sponsor of Health Systems Day at the conference, which included the Research Symposium. The 2008 Symposium and this follow-up report would not have been possible without this support. Additional funding for the Symposium was provided by the Bill and Melinda Gates Foundation and the David and Lucille Packard Foundation.

SpeakersRoger Glass (moderator), Fogarty Center for International Health, NIHAhbay Bang, Society for Education, Action and Research in Community Health (SEARCH)Jane Kengeya-Kayondo, The Special Programme for Research and Training in Tropical Diseases (TDR)Catherine Peckham, Nuffi eld Council on Bioethics

FacilitatorsMwelecele Ntuli Malecela, National Institute for Medical Research (NIMR), TanzaniaTherese McGinn, Heilbrunn Department of Population and Family Health, Mailman School of Public Health, Columbia UniversityMaria Merritt, Johns Hopkins Berman Institute of BioethicsSeema Shah, Department of Bioethics, NIAID, NIHJeff Spieler, U.S. Agency for International Development Susan Zimicki, Academy for Educational Development

AdvisorsRobert Eiss, Fogarty Center for International Health, NIHJamie Guth, The Special Programme for Research and Training in Tropical Diseases (TDR)Catherine Joynson, Nuffi eld Council on BioethicsJane Kengeya-Kayondo, The Special Programme for Research and Training in Tropical Diseases (TDR) Therese McGinn, Heilbrunn Department of Population and Family Health, Mailman School of Public Health, Columbia UniversityRobert Ridley, The Special Programme for Research and Training in Tropical Diseases (TDR)Harald Schmidt, Nuffi eld Council on Bioethics

Acknowledgements

The Bristol-Myers Squibb Foundation seeks to improve the health outcomes of populations disproportionately affected by HIV, hepatitis, serious mental illness and cancer. Recognizing the critical role of community-based care and support, the Foundation is developing and supporting partnerships that strengthen and integrate healthcare worker capacity and supportive services at the community level. The fl agship philanthropic initiative for Bristol-Myers Squibb that addresses the health disparities of people living with HIV/AIDS is called SECURE THE FUTURE™. Launched in 1999, it was the fi rst major corporate philanthropic program to target the epidemic in Africa. The goal of STF is to surface and support innovative, cost-effective, sustainable and replicable models to manage the impact of HIV/AIDS in resource-limited settings. The $150 million program has funded over 230 projects and evolved in 2008 to become a South-South Technical Assistance Program for mobilizing lessons learned and best practices via a faculty made up of grantees and partners who have done the work of creating and validating model approaches and interventions on the ground.

The Fogarty International Center, the international component of the NIH, addresses global health challenges through innovative and collaborative research and training programs and supports and advances the NIH mission through international partnerships. In the 40 years since its creation, support for international biomedical and behavioral research and research training by the Fogarty International Center has grown from its modest roots to a globe-encircling $66 million research, training, and capacity-building enterprise that extends to over 100 countries and involves some 5,000 scientists in the U.S. and abroad.

The only accredited school of public health in New York City and among the fi rst in the nation, Columbia University Mailman School of Public Health pursues an agenda of research, education, and service to address the critical and complex public health issues affecting millions of people locally and globally.The School’s Heilbrunn Department of Population and Family Health plays a vital role in realizing this important vision, working through a human rights perspective to focus on child, adolescent, and reproductive and sexual health, both in settled communities and in communities that have been displaced as a result of political or environmental emergencies.

The Nuffi eld Council on Bioethics examines ethical issues raised by new developments in biology and medicine. Established by the Nuffi eld Foundation in 1991, the Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust. The Council has achieved an international reputation for addressing public concerns, and providing independent advice to assist policy makers and stimulate debate in bioethics.

TDR, The Special Programme for Research and Training in Tropical Diseases, is a global program of scientifi c collaboration established in 1975, sponsored by the World Health Organization, World Bank, United Nations Development Programme and United Nations Children's Fund. Its focus is research into neglected diseases of the poor - both improving and developing new approaches, and expanding research capacity in the countries where the diseases are prevalent.

Partners and Cosponsors of 2008 Research Symposium

1 / USING RESEARCH TO STRENGTHEN HEALTH SYSTEMS AND MEET THE NEEDS OF COMMUNITIES

Introduction

Where would we like global health to be in 10 years? Roger Glass, Director of the Fogarty International Center and Associate Director for International Research, posed this question at the Global Health Council’s 2008 annual Research Symposium. This question could be addressed from the perspective of political leaders, corporate executives, service providers, program implementers or researchers, but the Symposium adopted the latter perspective. Beyond evaluating programs, the optimal role of research and researchers in developing and sustaining health systems and improving health at the community level requires further investigation.

In many regions of the world, the health needs of people and communities are not being met by either public or private sector providers. Identifying best buys, fi nding effective solutions and translating successes from one place to another have long been challenges to delivering care. Documentation of processes and outcomes are lacking for many programs; monitoring and evaluation is often an afterthought in program development. Social, economic and political conditions in one country or community limit the generalizability of programs and practices.

Communication is an essential component of incorporating research into communities. Both within the research community and with the local community, researchers need to communicate with each other and with those who will be affected by their work. Local leaders, advocates and study participants need to be engaged with researchers, sharing their concerns, ideas and suggestions.

In recent years, the realization that solutions need to engage local communities has grown, yet in many regions of the world community participation is nominal, with little opportunity for substantive and constructive contribution to the studies undertaken or programs implemented. In developing countries, donors, service providers, program implementers and researchers may be uncertain how to incorporate input from a population with little formal education or understanding of the importance of research in optimizing prevention, treatment and care. Yet, working with the community is an essential component of successful and ethical programming.

The defi nition of research may vary. A strict interpretation of “research” that focuses on rigorously designed experimental studies is limited, particularly in developing countries in which imperative health needs require concurrent service provision and data collection. Operations or implementation research is needed to optimize intervention efforts and maximize limited resources. The scope of these studies may include both outcomes and process assessment. Monitoring and evaluation of programs can provide valuable information and a framework for gathering additional data. Qualitative studies and investigation of the social determinants of health in these cultures are needed to

USING RESEARCH TO STRENGTHEN HEALTH SYSTEMS AND MEET THE NEEDS OF COMMUNITIES / 2

understand behaviors that infl uence use of services and adherence to prevention and treatment regimens.

These issues provide the context for the 2008 Global Health Council Research Symposium. Discussion focused on the role of research and researchers in working with the community to advance both knowledge and health care, with special attention to capacity building, appropriate technologies and public health ethics.

The Symposium Format

The Global Health Council’s Research Symposium was held on May 28, 2008, in Washington, DC, with a diverse, international gathering of about 150 practitioners, program implementers and researchers. The goal of the Symposium was to identify the challenges faced by community-level health systems in these areas and to determine the priorities for researchers, working in partnership with governments and the private sector, in developing feasible solutions. Moderated by Roger Glass of the Fogarty International Center, the Symposium combined presentations by leading experts and breakout discussion groups. Discussion focused on three content areas: building capacity for research in the community, using appropriate technology in community-based research, and applying ethical guidelines and considerations in community-based research. The discussion groups were asked the following questions:

What research questions need to be addressed on this topic? n

What are the research priorities for this topic? n

What messages need to be conveyed to and by the community about the n

implementation of research studies on this topic?

How is long-term sustainability of activities – funding, infrastructure, research n

capacity – achieved?

The Symposium was co-sponsored by the Global Health Council, Bristol-Myers Squibb Foundation, the Special Programme for Research and Training in Tropical Diseases of the World Health Organization (WHO), the Heilbrunn Department of Population and Family Health at the Mailman School of Public Health of Columbia University, the Nuffi eld Council on Bioethics and the Fogarty International Center of the U.S. National Institutes of Health.


Presentation

Dr. Jane Kengeya-Kayondo, from TDR, discussed a study of the use of integrated community-directed interventions (CDI) to deliver a variety of treatments to patients in Cameroon, Nigeria, and Uganda. CDI was originally developed to treat onchocerciasis. Five treatments of differing complexity were examined: community-directed treatment by village volunteers of ivermectin (CDTi) for river blindness (onchocerciasis) and home management of malaria (HMM), vitamin A, DOTS treatment for tuberculosis, and distribution of insecticide-treated bednets (ITNs) to prevent mosquito bites that transmit malaria. Within the three countries in the study, there were seven study sites, covering 35 health districts and 2.3 million people. Each study site included four CDI intervention districts and one comparison district. Communities in the comparison districts received treatment through traditional distribution methods (see Table 1).

Capacity Building

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Table 1: Design of Research Study on Community-Directed Ivermectin Treatment1

In all of these cases, implementation using the CDI approach was the same or better than traditional methods and results tended to improve over time. For example, within one year of the inclusion of home management of malaria through CDI, the proportion of children receiving appropriate treatment was nearly double the proportion in the comparison districts. After two years of HMM, the proportion of those receiving appropriate treatment in the intervention districts surpassed the Roll Back Malaria target (see Figure 1).


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In addition to the increases in service delivery, costs were lowered through the community-directed approach. The only major barriers not overcome by the program were logistical problems, including supply shortages. Furthermore, the project helped to increase awareness of health issues and the ability to access interventions, boost the participation of women in community meetings and build ties between CDTi implementers and other health workers.

As a result of this success, the African Programme for Onchocerciasis Control (APOC) is expanding CDI to all the communities where this service is provided. New research supported by TDR is investigating how to incorporate this into villages that have never used CDI. Dr Kegeya noted the need for supportive health policies and reliable supply chains to make CDI possible. Several questions remain in implementing the CDI approach: How can resource gaps in research in large-scale integrated community interventions be fi lled? What critical factors should be addressed through research in large-scale integrated community interventions? How can the formal and informal private sector be harnessed and engaged in this research?


Capacity Building Discussion Summary

In the group discussion, participants raised numerous questions sparked by the presentation. Many questions and comments pertained to resource gaps in research on large-scale integrated community interventions and the role of the formal and informal private sector.

In identifying and prioritizing the pressing research questions on capacity building in communities, the discussion group identifi ed two distinct issues: capacity building for research and research on capacity building. The group focused on the former, generating a series of questions. In addition to the fundamental research-related needs to identify the current gaps, available resources and potential partners, the questions focused on creating linkages, increasing or maximizing resources, fi nding commonalities between players, and identifying areas of focus:

Creating linkages

How can we create linkages between researchers and fi eld/program staff? n

How can we integrate academic and programmatic research? n

How can we include communities in the research process to increase study n

participation?

How do we create linkages between those conducting research and those n

utilizing research?

Increasing/maximizing fi nancial and human resources

How do we prioritize research when funding is scarce? n

How can we increase human and fi nancial resources for research? n

How can we build capacity of fi eld staff, including program managers? n

How do we decrease cost and improve quality of research? n

How do we increase research capacity among medical professionals? n

Finding commonalities

How can we create a common defi nition of research? n


Can we agree on a common method of n

integrating research into programs?

Can we agree on a common method for n

dealing with data from the fi eld?

How do we foster an appreciation for data n

and data collection?

Identifying areas in need of research

When do we conduct more research and n

when do we utilize the existing body of knowledge?

How do we handle research when evaluation is begun only after a program is n

implemented? Where should we be focusing efforts: formative-, process-, outcome-based research?

Should we be focusing research on new or existing programs? n

Is research or program implementation the end goal of projects – and how can n

these dual goals be reconciled?

Does participation improve the quality of research? What are its benefi ts and n

limitations?

With regard to long-term sustainability of activities, funding gaps, infrastructure needs and research capacity issues were the main areas of discussion. In addition to large gaps in current investments, the group identifi ed lack of advocacy efforts, restricted funding for research and complications in accessing potentially available funds, i.e., complex processes inhibit access to available resources. Among the infrastructure issues raised was a need to encourage information- and experience-sharing on the national, regional, and global levels, and a need to encourage debriefi ng that will facilitate translation of experience into policy and/or practice. The research capacity issues discussed include a lack of capacity for developing proposals, a need to prioritize research and a need to encourage people to apply for research funding options.

How can we include

communities in the

research process

to increase study

participation?


Presentation

Dr. Abhay Bang, Director of the Society for Education, Action, and Research in Community Health (SEARCH) based in Gadchiroli, Maharashtra, India, focused his presentation on the topic of research on the use of appropriate technology for health care at the community level. He presented his research on care and management of neonatal sepsis using a novel health care delivery mechanism. The study investigated whether neonatal sepsis could be managed at home by village health workers under supervision of a physician, as a means of reducing by 50 percent the neonatal and infant mortality rates.

Dr. Bang opened his dynamic presentation with the statements: “knowledge is the new form of wealth” and “there is a fortune at the bottom of the pyramid.” In asking why appropriate technology and what is appropriate, he refl ected that the social context, the problem addressed, the human power, the technologies used and the resources/cost of services must all be appropriate to the specifi c community being considered. He posited that this – achieving what is appropriate for specifi c developing-country communities – is the challenge in fi nding effective health-care solutions.

In the rural villages in this region of India, neonatal care was not available to the overwhelming majority of families. In this region, nearly 60 percent of under-fi ve deaths were due to neonatal causes – the leading neonatal causes being prematurity, birth asphyxia, injury and infections. Literacy among adult females and low-birth weight among newborns stood at roughly 40 percent. In the early nineties, 95 percent of women gave birth at home because hospitals offering neonatal care were too far geographically, the cost of care was too expensive or traditional views impeded accessing health services. His organization’s earlier research fi ndings that home-based care of pneumonia in neonates could reduce the neonatal mortality rates provided encouragement for this research in the community.

Literate female health workers were trained to manage and care for sepsis in 39 out of 100 villages. They were given a checklist (see Table 2) to appropriately diagnose sepsis in newborns. In addition, they were equipped with a kit containing low-tech interventions and medications, including cotrimoxazole and gentimicin for sepsis.

Appropriate Technology


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Table 2. Checklist for Community Health Workers to Diagnose Neonatal Sepsis3

Between 1988 and 2003, the infant mortality rate (IMR) in this region declined from approximately 120 to 30 deaths per 1,000 live births, largely due to the adoption of pneumonia case management in 1988 and home-based newborn care in 1995 (see Figure 2). When the home-based newborn care using community health workers was instituted in 1995, the area had experienced a stagnated IMR for fi ve years. The home-based care program was effective in re-establishing the downward trend in infant mortality rates – the IMR decreased by more than 50 percent between 1994 and 1997. In addition to drastically reducing neonatal and infant mortality over the three years of the study and beyond, the program lowered the costs of care while reaping multiple (including long-term) benefi ts for this community.


The evaluation of the study addressed:

Relevance to community. The study was highly relevant to the community for several reasons. Before this study, neonatal care was virtually inaccessible. The study involved the traditional birth attendants in the community who pre-date the research project. The village health workers in the study were all residents of the community.

Effectiveness of the intervention. The intervention was highly effective in reducing neonatal mortality, building the capacity of women in communities to become village health workers, and providing in-home and free options for care to families.

Cost of the program. The services were provided free-of-charge to families, with the end result being a total cost of $5.30 per newborn. This compares with a cost of $ 20 to 40 per day of care for newborns in urban hospitals (with stays averaging 8 to 10 days).

Ethical provision of care. The intervention received permission of the advisory board and written permission of families to provide care at home. Although the use of simplifi ed diagnostic criteria allowed for over-diagnosis of sepsis, lack of laboratories and the need

Figure 2. Effect of Home-Based Neonatal Care on Infant Mortality in Gadchiroli, Maharastra3


for urgent care justifi ed the use of this method. Of the newborns in 30 villages participating in the study, 6.5 percent were treated with antibiotics, a rate similar to newborns treated in hospitals in Boston and India. Though the care offered to the newborns in this study was not equivalent to the highest quality of care available at the time in the wealthiest countries, as some prominent ethicists have argued it should be, Dr. Bang emphasized that this care was the best quality available in the villages. Moreover, simplifi ed and appropriate care to neonates in developing countries cannot be denied on the grounds that the rich countries have better care.

Empowerment of women. This study promoted the inclusion of women from the community as trained village health workers. In addition, health education was provided to mothers and grandmothers in year three of the study.

Dr. Bang concluded his presentation by asserting that the most innovative research ideas are found by speaking with the people in the communities. He left the audience with a Chinese proverb: “Go to the people, live among them, love them, listen to them, learn from them, begin with what they know, build upon what they have.”

“Go to the people,

live among them, love

them, listen to them,

learn from them,

begin with what they

know, build upon what

they have.”


Appropriate Technology Discussion Summary

The discussion following the presentation focused on two topics: research priorities in appropriate technology and research questions that need to be addressed. In addition, there was a discussion about the sustainability of projects similar to Dr. Bang’s neonatal sepsis program.

Research priorities for appropriate technology

How can the importance of concentrating on health systems research in developing n

countries be emphasized or highlighted?

How can appropriate technology be used to address illiteracy? n

How can oral learning/teaching/culture be used as (or in) research n

methodologies?

How can prevention, health education and behavioral change communication be n

revisited in an appropriate technologies context?

How can n good fi t and good point-of-care technology be used to take solutions to the problems? For example, a two-year study is currently underway in Eastern Nepal to assess the training of nurses to take portable ultrasound equipment (“video x-ray”) to rural areas.

Research questions that need to be addressed

How can research best address the issue of empowerment? n

How can messages be conveyed to the community about appropriate technology? n

Drawing on Dr. Bang’s research on neonatal sepsis, discussion of sustained funding included testing cost-effectiveness compared to treatment in hospitals (or other standard of care modalities) and program effectiveness compared to the processes formerly practiced. The potential to sustain the infrastructure developed in programs is also key. In Dr. Bang’s study, capacity was increased because female village health workers were trained, care kits had already been developed, and the interventions were virtually all low-tech, with only one physician needed to evaluate the quality of care by the village health workers.


In July 2008, the Global Health Council had the opportunity to interview Dr. Abhay Bang for an online discussion group that grew out of the Symposium.

Question : Several research studies and programs (e.g. Bangladesh Projanhmo, IMNCI India and the pilot study in Pakistan, etc.) fail to include either the management of birth

asphyxia or sepsis with antibiotics in their neonatal care models – and semi-skilled health workers often serve larger populations with less competitive remuneration and training than the workers in Gadchiroli. Are these the reasons the home-based neonatal care (HBNC) models in Gadchiroli/Ankur models reduced the neonatal mortality rate (NMR) by much more (on average) than the other, less-comprehensive models of neonatal care?5-9

Answer: Analysis of the Gadchiroli trial revealed that the impact on NMR can be attributed mainly to three components: 1) the management of sepsis/pneumonia - 36 percent; 2) the

management of preterm/low birth weight (LBW) - 33 percent; and 3) Management of asphyxia - 20 percent.3 Any package which excludes some of these will lose proportional impact. The IMNCI package has, to my knowledge, not been shown to have impact on the NMR/IMR. No data are published/made available on the impact. Another reason for the larger effect in Gadchiroli/Ankur is the frequency of home visits by the community health worker (CHW). The clinic-based neonatal care arm in the Projanmo trial showed little effect on the NMR.

Question: The Ankur project had several fi ndings: 1) HBNC is still useful in places where women are more willing to give birth in hospitals; 2) HBNC works in both rural and

tribal areas (less so in slums); and 3) that NGOs are capable of replicating and sustaining this model of care.9 Why did the Ankur model have lower results in slums? What’s being done to test alternative options neonatal care for those areas?

Answer: The effect in the urban slums was less than in the rural or tribal areas because a truncated HBNC package was introduced, due to the availability of doctors and hospitals

in urban areas. CHWs were not trained to treat sepsis, and they rarely managed asphyxia. These restrictions reduced the impact. Since hospital care plays more of a role in urban areas, improving the quality of perinatal care in public hospital is equally important in urban areas.

Question: Kangaroo mother care (KMC) for preterm or low-birth weight neonates failed to be taken up by the community in Gadchiroli. Do you think it will succeed in reducing

mortality in other areas of India? Why or why not?

Answer: Acceptance of KMC by women in Gadchiroli was poor. They had their practical and cultural diffi culties. The problem of baby soiling 8-12 times each day, making mothers’

bodies dirty, needs to be solved. The study of community-based KMC in Bangladesh did not show any impact on NMR, but the one in Shivgarh (India) showed impact. Hence we need to understand the reasons and mechanisms of the reported acceptance in Shivgarh.10-12

Questions and Answers with Dr. Abhay Bang


Question: You mentioned that there was a “fatalistic” attitude toward providing newborn care in pre-intervention Gadchiroli, as community members assumed it

was impossible to save the lives of newborns and thus neglected to try. This outlook was/is probably common in many other developing communities. Is this changing fi nally in India?8

Answer: The fatalistic outlook has not changed in India as a whole. But after a real life experience in their own community that the HBNC can save sick neonates – the

fatalistic outlook changes. This is occurring in a few pockets where such alternative form of care is made available. It suggests that people are dynamic, open to change.

Question: Sub-Saharan Africa seems at least a decade behind South Asia with regards to neonatal care. Traditional beliefs, practices and misconceptions towards care,

along with costs unaffordable to many, pose signifi cant hurdles. Are you aware of any results from models of home- or even community-based neonatal care in the region?13, 14

Answer: Not so far, but Malawi, Zambia, Ethiopia are piloting the HBNC care provided by outreach workers or CHWs. Other studies, such as the home-based antiretroviral

treatment (ART) to HIV-positive persons provide reason to believe that it is possible to provide home-based care in Africa. And frankly I don’t see any other practical alternative but the HBNC or a similar approach which can be made available to neonates in Africa. Hospital-based or doctor-dependant neonatal care is just impossible, at least for few decades.

Question: You cite the SEARCH’s ability to establish rapport with the communities in Gadchiroli as one of the main reasons for success with HBNC. How did you manage to do

this upon arriving to the villages?3

Answer: It is a process question. The answer is provided by the famous Chinese poem: “Go to the people, live among them, love them, learn from them, begin with what they know, Build

upon what they have.” In more practical terms, if your solution addresses a real need, if you can communicate it in culturally appropriate way, and if the community can witness results – you gain trust.

Question: What advice do you have for African practitioners searching for feasible interventions?

Answer: Since Africa has a health manpower crisis, more health care roles need to be delegated to CHWs. Don’t hoard medical skills but train and delegate.


Question: What should the top three health research priorities be for MNCH in India?Is testing the current model of IMNCI among them? If it is not proven to be

effective, do you think IMNCI in India will eventually include the presence of skilled birth attendants at delivery, and tools for the management of sepsis and birth asphyxia?

Answer: The IMNCI is a step in right direction. It has added preliminary neonatal care to the sick child management in IMCI. But more interventions need to be added. Since

nearly 30 to 40 percent newborn deaths occur on the day of birth, and another 36 to 52 percent occur due to neonatal infections, interventions such as being present at birth, more frequent home visiting, home-management of asphyxia and sepsis are necessary. The choice of worker needs to shift from the already over burdened ICDS worker to the CHW (ASHA in India). Adequate training (28 days, and not merely 8 days) needs to be provided. In short, the IMNCI needs to adopt HBNC. And fi nally, the evidence about the impact of IMNCI pilot studies on the NMR/IMR needs to be made public.

Question: In your opinion, what are the top research priorities for all areas of health in India?

Answer: 1) Ways of providing fi nancial coverage to those who cannot afford to buy medical care; 2) Prevention and management of the epidemic of cardio-vascular diseases in India;

3) How to operationalize the HBNC and child survival package on a large scale; and 4) Chronic undernutrition among women and children.

Question: Measles, polio and a high maternal mortality ratio persist in spite of India’s recent economic advances. As India is considered a middle-income country, can you address the

question of fi nancing vaccines to achieve universal access for mothers, infants and children in middle-income countries?

Answer: India as a whole is not a middle income country - maybe 25 percent of the population is - but 75 percent of the population does not have adequate access to basic

health care. Middle-income India is a myth created by the media. The euphoria is limited only to the middle class. Farmers in villages are committing suicide in large numbers.

Question: Over the next few decades, do you believe that increases in human capital will slowly help to raise the quality of health and education in the poorest states?

Answer: It will not happen automatically. Conscious policy decisions, allocation of resources, good quality training and subsequent support will be necessary to make that

happen. The potential exists in people; can the policy makers and program managers respond to the challenge?

Presentation

Professor Catherine Peckham, from the Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health, University College London, described the Nuffi eld Council on Bioethics’ 2002 report, entitled, The Ethics of Research Related to Healthcare in Developing Countries and the 2005 follow-up report entitled, The Ethics of Healthcare Related Research in Developing Countries: a Follow-Up Discussion Paper.15, 16 These seminal reports provided a framework for investigators and implementers who were designing or conducing global health research projects in developing countries.

The ethical framework underscored the importance of applying key principles while keeping in mind the social, cultural and economic contexts of the community. The four main principles (or duties) identifi ed in the framework focus on alleviating suffering, showing respect for persons, being sensitive to cultural differences and not exploiting the vulnerable. Within this framework, the reports highlighted four areas of concern to be addressed before a study can be conducted:

Informed ConsentThe consent process aims to inform and protect the study participants. The process must be locally appropriate, e.g. in some cultures, the household decision-maker should be consulted in addition to the participant. Gaining the trust of the participants is paramount. Forms, if used, must be simple. The reports also encouraged fi nding innovative ways to obtain consent that are acceptable to the community. For example, when working with illiterate populations, consent may be obtained verbally in the presence of witnesses or community meetings may be used to communicate the purpose and risks of the trial. Some researchers have even used pictures or mobilized local youth to convey the messages through dance and theatrical presentations.

Standards of CareSome experts argue that the standard of care received by study participants in developing countries should be equivalent to what would be provided in high-income countries, even if such treatment is not feasible in the developing country. The reports defi ned a universal standard of care as, “the best current method of treatment available anywhere in the world for a particular disease or condition.” A non-universal standard of care was defi ned as, “the treatment available in a defi ned region.” The reports noted that benefi cial research may be precluded if

Research Ethics in Developing Countries


a universal standard of care was applied in developing countries that lack the necessary technology, treatment or conditions. Requirements related to placebo use or sponsor payment for universal standard of care may also derail proposed research studies. The reports indicated that situations should be evaluated individually and that provision of the local standard of care was indeed acceptable in some situations.

Ethical Review The review process is designed to protect study participants. Research ethics committees (RECs) or institutional review boards (IRBs) are needed to review the ethical and scientifi c aspects of proposed studies, keeping in mind the relevance of the study to the health care priorities within the developing country. Developing countries may lack RECs and/or the capacity to thoroughly evaluate research proposals. There is a need to increase the effi ciency of RECs and improve communication between RECs. Equally important are initiatives to develop expertise in ethical review through training and capacity building.

Post-research Activities Conveying information to the community and ongoing access to treatment for research study participants are key issues in the post-research trial period. When interventions are shown to be effective, the results and opportunity for scale-up activities should be available to the wider community. The reports noted several long-term benefi ts of research for communities in developing countries, including an increase in the number of health workers, the development of scientifi c expertise and the potential for sustained improvement in health care in the communities.

It was noted that the Nuffi eld Council reports were principally relevant to large-scale studies carried out in developing countries by researchers from developed countries. There needs to be further consideration of the ethical issues raised by implementation/operations research, such as that described by Dr Bang, in order to optimize efforts in resource-poor countries.


Research Ethics Discussion Summary

In the discussion group, several relevant questions and issues were raised. The group discussed which research questions need to be discussed and prioritized, standard of care and multinational research issues. Using the example provided by Dr. Abhay Bang’s presentation on selecting certain women from the community to deliver health care, the group cited the need for more research on the effects of a study in a given community.

Research questions related to ethics in community-based research

How applicable to community-based/public health research are ethics guidelines n

originally designed for clinical research?

How can ethics guidelines be developed specifi cally for this type of research? From n

where can this ethical guidance come?

What is the impact of a study in a given community? For example, Dr. Bang’s n

selection of certain women to deliver health care – what effect does the research study have on these women and the larger community?

Ethical issues in multinational research

How can the importance of informed consent be conveyed? How can study n

participants be encouraged to ask questions? How can researchers develop consent forms in simple language that also convey complex scientifi c or medical information?

How can additional research investigate the level of understanding among n

participants both before and after a trial? In what ways should the research process be sensitive to cultural differences and community context?

How can confl icting or different review board standards be resolved? What n

protocols or guidance can be used to develop evaluation and resolution strategies? How can more education and training on reviewing research methodology be implemented in developed countries?

How can issues related to sensitive topics, culture and context be prioritized for n

research conducted in developing countries?


Standard of care debate

When the success of an intervention n

is demonstrated, what happens to the control group; what provisions are made for them to access the successful intervention?

Does the researcher have a greater n

responsibility to advocate for implementation of the new intervention among the control community before others receive access?

When a successful intervention is found for community-based research, what are n

the obligations for future research when thinking about the appropriate baseline for comparison?

Does the baseline change in light of the new information? n

What responsibilities do those involved in community-based research have at the n

policy level?


What responsibilities

do those involved in

community-based

research have at the

policy level?

In his concluding remarks, Dr. Roger Glass, from the Fogarty International Center at the National Institutes of Health, enumerated several long-term goals for global health and systems-strengthening research that were supported by the presentations and discussions.

Beginning with the question, where would we like to be in 10 or 12 years in global health? Dr. Glass refl ected on the changes in the past 10 years, noting that Bill Gates only fi rst learned about rotavirus 10 years ago. Comparing global health 10 years ago and global health today, the exponential growth in both attention and funding is apparent and makes predicting where we will be in another 10 years challenging. Dr. Glass highlighted the need for the global health community to capitalize on this upsurge in interest on the part of medical professionals, students and business people. He added that youth are gaining exposure to global health in childhood and people are becoming engaged in projects early in their careers, begging the question of whether they will remain engaged in global health over the next 10 to 20 years.

Dr. Glass pointed to long-term training for people in global health as an area in need of attention. Several events have brought signifi cant change to global health, including the reauthorization of large-scale funding programs, the rise and decline of infectious diseases, and the development of new technologies. To deal with existing and emerging global health issues, new technologies will need to be developed and diverse groups of people will need to be engaged. Additional training is required to provide a foundation for delivering public health programs and expanding research efforts. Examples of potential activities designed to meet future needs include building up small grants programs in Africa and incorporating a line item for training and capacity building in grants related to work in developing countries.

Another area that needs increased attention is the application of long-term approaches to gather information about patients and engage the community in health and research efforts. Labeling recent large-scale investments in global health as “a big experiment,” Dr. Glass suggested that until the PEPFAR* program, medical records were rarely maintained and reviewed in clinics. HIV/AIDS reinforced the need to consider a comprehensive and longitudinal approach to health care. The global health community is challenged to

*PEPFAR: Initiated in 2003, the President’s Emergency Plan for AIDS Relief provided over US$15 billion to more than 100 countries over fi ve years. Approved in 2008, the second phase of PEPFAR provides US$48 million to combat global HIV/AIDS,

malaria and tuberculosis over fi ve years.

Closing Remarks


determine how to track patients over time and across providers and how to engage people in the ongoing provision of health care.

Dr. Glass cautioned against becoming too complacent with the great successes global health has achieved to date. Malaria provides an interesting global health case study, as the past half-century has included several efforts to reduce the impact of the disease. At a 2007 luncheon celebrating the successful control of malaria in Zanzibar, the Minister of Health noted that this was the third time that Zanzibar has achieved this feat.17 The country’s fi rst containment of malaria occurred in the 1960s, when the WHO’s malaria eradication campaign brought widespread use of DDT. However, progress achieved in controlling the disease was reversed after the program was discontinued. Disease rates soared. The second large-scale effort to control the disease occurred in the 1980s, as another WHO-sponsored malaria program resulted in substantial progress in reducing cases. Yet again, after successfully controlling the disease, program funding ceased and the country experienced an epidemic. Most recently in 2005, the President’s Malaria Initiative adopted Zanzibar as one of its focus sites, thus initiating the third effort to control malaria; they are currently implementing a 5-year scale-up plan with the assistance of several international partners. These interventions include indoor residual spraying, the provision of insecticide-treated nets and artemisin-combination treatments (ACTs), and rigorous prevention planning with the establishment of a top-quality surveillance and response system.18 These efforts have resulted in tremendous progress in Zanzibar. Hopefully, as they are growing closer to achieving the goal of detecting and accurately diagnosing malaria, the progress made against this old scourge will continue and malaria in Zanzibar will soon be eliminated.

In order to sustain global health in the future, Dr. Glass noted the need to replace or supplement the Centers for Disease Control and Prevention programs in local areas. The implementation of science and research efforts, local ownership and treatment, cheaper drugs, and better ways to handle these issues across all areas of public health – from child health to chronic diseases – were cited as critical to future success in meeting health needs. Global health challenges inherently involve a need to reconcile cultural differences, underscoring the need to study ethical issues and use knowledge, understanding and sensitivity when addressing these challenges. This is a time for the global health community to capitalize on the high levels of interest in global health issues among both public and private sector players. In order to succeed, groups such as the Global Health Council and the Fogarty International Center need to cooperate and coordinate efforts that address these challenges and make the most of the high level of attention currently given to global health in the media.


In closing, Dr. Glass challenged stakeholders in global health to think about the long-term objectives and opportunities. The need to train the leaders of tomorrow and recognize “the great experiment” of global health that is constantly evolving are critical to success. By recognizing that global health is an experiment, one acknowledges the inherent need for both investigations related to health outcomes and implementation/operations research to fi nd long-term solutions to complex problems. Long-term thinking also necessitates the need to develop future technologies and modalities that can work in developing countries, and the need to adapt currently available interventions and programs. For example, innovative ideas are needed to maximize utility of the internet, cell phones and other devices that can increase accessibility of both information and health care interventions. Dr. Glass concluded with the caution that if we do not continue the dialogue and the progress on global health issues, we will be in the same place 5 years down the road.

The dialogue that began at the Research Symposium can continue to evolve in future forums, including those on the web. The online follow-up discussion of topics of the 2008 Research Symposium: Using Research to Meet the Needs of Health Systems and Communities can be found at http://blog4globalhealth.wordpress.com/research_projects/2008-research-symposium/


References1 World Health Organization. 2008. Community-directed interventions for major health problems in

Africa. Available from: http://www.who.int/tdr/publications/publications/cdi_report_08.htm2 Bang AT, Bang RA, Stoll BJ, Baitule SB, Reddy HM, Deshmukh MD. 2005. Is home-based diagnosis and

treatment of neonatal sepsis feasible and effective? Seven years of intervention in the Gadchiroli fi eld trial (1996 to 2003). Journal of Perinatology 25:S62-S71.

3 Bang AT, Bang RA, Reddy HM. 2005. Home-based neonatal care: summary and applications of the fi eld trial in rural Gadchiroli, India (1993-2003). Journal of Perinatology 25:S108-S22.

4 Bang A. Follow-up interview with Dr. Abhay Bang. Google groups: Global Health Council Research Symposium. (accessed July 18, 2008), Available from: http://groups.google.com/group/ghc-research-symposium/browse_frm/thread/dd02ca701dbc308d?hl=en

5 Baqui AH, El-Arifeen S, Darmstadt GL, et al. 2008. Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomized controlled trial. Lancet 371:1936-44.

6 Ingle G, Malhotra C. 2007. Integrated Management of Neonatal and Childhood Illness: an overview. Indian Journal of Community Medicine 32(2):108-10.

7 Bhutta ZA, Memon ZA, Soofi S, et al. 2008. Implementing community-based perinatal care: results from a pilot study in rural Pakistan. Bulletin of the World Health Organization 86(6):452-9.

8 Bang A, Bang RA, Baitule SB, Reddy MH, Deshmukh MD. 1999. Effect of home-based neonatal care and management of sepsis on neonatal mortality: fi eld trial in rural India. Lancet 354:1955-61.

9 Bang A. 2008. Feasibility and effectiveness of replicating the home-based newborn care: the ANKUR project. Available from: http://www.globalhealth.org/conference_2008/presentations/f4_a_bang.pdf

10 Bang A, Baitule SB, Reddy HM, Deshmukh MD, Bang RA. 2005. Low birth weight and preterm neonates: can they be managed at home by mother and a trained village health worker? Journal of Perinatology 25:S72-S81.

11 Sloan N, Ahmed S, Mitra SN, Choudhury N, Chowdhury M, Rob U, et al. 2008. Community-based kangaroo mother care to prevent neonatal and infant mortality: a randomized, controlled cluster trial. Pediatrics 121(5):e1047-59.

12 Darmstadt GL. A community-based and community-driven essential newborn care program. 2005 (accessed, Available from: http://www.coregroup.org/resources/meetings/april05

13 Mrisho M, Schellenberg J, Mushi A, Obrist B, Mshinda H, Tanner M, et al. 2008. Understanding home-based neonatal care practice in rural southern Tanzania. Transactions of the Royal Society of Tropical Medicine and Hygiene 102:669-78.

14 Waiswa P, Kemigisa M, Kiguli J, et al. 2008. Acceptability of evidence-based neonatal care practices in rural Uganda -- implications for programming. BMC Pregnancy and Childbirth 8:21.

15 Nuffi eld Council on Bioethics. 2002. The ethics of research related to healthcare in developing countries. Available from: http://www.nuffi eldbioethics.org/fi leLibrary/pdf/errhdc_fullreport001.pdf

16 Nuffi eld Council on Bioethics. 2005. The ethics of healthcare related research in developing countries: a follow-up discussion paper. Available from: http://www.nuffi eldbioethics.org/fi leLibrary/pdf/HRRDC_Follow-up_Discussion_Paper001.pdf

17 Glass IR, Fauci AF. 2007. Defi ning and defeating the intolerable burden of malaria III: progress and perspectives: introduction. Am J Trop Med Hyg 77(Suppl 6):iv-v.

18 McElroy S. Zanzibar: beyond malaria control. President’s Malaria Initiative. (accessed February 3, 2009), Available from: http://www.fi ghtingmalaria.gov/countries/profi les/zanzibar.html

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