path: a catalyst for global health - duke university

PATH: a catalyst for global health

We envision a world where health is within reach for everyone

2

FEDERAL GRANTS : FOREIGN COMPONENTS

ANTICIPATING AND CLEARING HURDLES TO STUDY IMPLEMENTATION

3

Introductions Special considerations for international research projects Impacts: timeline, budget, research design and scope Case study: Evaluation of a Diagnostic Test in Nairobi,

Kenya Case study: Introducing UltraRice in Bujumbura, Burundi Case study: Evaluation of a Diagnostic Test in Kisumu,

Kenya Summary and discussion

AGENDA

4

Kathy Tietje Toni Lindquist

Program for Appropriate Technology in Health (PATH)

Seattle, Washington Washington D.C.

http://www.path.org

Introductions

PATH: Program for Appropriate Technology for Health

PATH is an international nonprofit organization that

creates sustainable, culturally relevant solutions,

enabling communities worldwide to break

longstanding cycles of poor health. By collaborating

with diverse public- and private-sector partners, we

help provide appropriate health technologies and

vital strategies that change the way people think and

act. Our work improves global health and well-being.

About PATH

We work in more than 70 countries around the world

• Headquartered in Seattle, Washington

• Offices in 34 cities

PATH COUNTRY OFFICES

7

Belgium * Brussels

Cambodia * Phnom Penh

Ethiopia * Addis Ababa

France * Ferney-Voltaire

India * Bhopal * Hyderabad * Lucknow * Mumbai * New Delhi

China * Beijing

Ghana * Accra

Nicaragua * Managua

Côte d’Ivoire * Abidjan

Kenya * Kakamega * Nairobi

Nigeria * Abuja

DR Congo * Kinshasa

Malawi * Lilongwe

Peru * Lima

PATH COUNTRY OFFICES

8

Senegal * Dakar

South Africa * Durban * East London * Johannesburg

Thailand * Bangkok

Uganda * Kampala

United States * Seattle * Washington DC

Viet Nam * Hanoi

Tanzania * Dar es Salaam

Ukraine * Kyiv

Zambia * Lusaka

PATH REVENUE SOURCES

Foundations 63%

Corporations <1%

US Government

24%

Other NGOs, multilaterals

9%

Individuals/other 3%

Investments 1%

AGENDA

10

Introductions Special considerations for international research

projects Impacts: timeline, budget, research design and scope Case study: Evaluation of a Diagnostic Test in Nairobi,

Kenya Case study: Introducing UltraRice in Bujumbura,

Burundi Case study: Evaluation of a Diagnostic Test in Kisumu,


Identifying Subcontractors

11

Proposal Award Study Start-up

Providing subcontractor information in the proposal – working from established collaborations.

Key questions during pre-award: • Have you collaborated before – how did it go?

• Do they have required infrastructure – grant/contract office; registrations, etc?

• Have they ever worked under a US federal government award before?

• Due diligence – financial status, FDA findings, etc.

12

Identifying Subcontractors

Required Applicant Information

Key personnel institutional affiliations

Performance site addresses

Administrative contacts

Assurances and registrations

• DUNS

• Animal Welfare Assurance/Foreign Institutions

• Federal-wide Assurance (FWA)

• eRA commons (organization and individual)

13

Unanticipated/Undefined Subcontracts

14

Proposal Award Study Start-up

When foreign components are added after award, prior approval from NIH is required. Consult with your NIH Program Officer early and often. S/he is required to submit a foreign clearance request before the activity can begin.

15

NIH Foreign Clearance

“The Fogarty International Center ( FIC ) is the international component of the NIH. FIC is involved in the foreign clearance process for domestic grants that will utilize foreign sites for the conduct of the research. The process for obtaining foreign clearance can take a considerable amount of time. ”

http://www.nhlbi.nih.gov/crg/funding_studyforeigngrants.php

“Foreign component” as defined by NIH

The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended.

Activities that would meet this definition include, but are not limited to:

(1) the involvement of human subjects or animals, (2) extensive foreign travel by grantee project staff for the

purpose of data collection, surveying, sampling, and similar activities, or

(3) any activity of the grantee that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. (Foreign travel for consultation is not considered a foreign component.)

18

“Foreign component” as defined by NIH

19

AGENDA






20

RESEARCH STUDY

Timeline, budget and scope are co-dependent.

Timeline Impact

Foreign partnerships can add time to study start-up –

Registrations (FWA, DUNS, EIN, etc)

Multiple IRB approvals

Geopolitical landscape

Contracting process

21

Timeline Impact (con’t)

Foreign partnerships can add time to study implementation –

Monitoring data collection/research activities – on site or remotely

Funds transfer; staffing

Shipping in – customs

Shipping out - specimens

22

Budget Impact

Travel prices fluctuate with energy costs

Extending timelines is costly

Equipment may need to be retrofitted for electrical supply (or lack thereof)

Shipping/customs costs can be unpredictable

Additional liability insurance 23

Scope Impact

Decreasing timeline or budget may require a reduced project scope.

Projects involving use of human specimens – may require analysis and/or banking in country.

Overly optimistic resource expectations – facilities, internet, phone service, electricity….

24

Mitigating Risks to Timeline, Budget and Scope

1. Identify and rank risks (impact of risk)

2. Develop mitigation strategies

3. Meet with collaborators in person and on site when possible

4. Seek out and account for known differences: cultural, methods of communication, holiday schedules, time zones, government processes, institutional procedures

25

AGENDA

26






CASE STUDY #1: University of Nairobi

Funding Source: NIH –

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Evaluation of a prototype CD4 test: University of Nairobi

Research Goals

CD4 is a protein marker expressed on immune system cells. High CD4 levels indicate a healthy immune system.

Used in HIV+ populations to decide when drug treatments might be needed (but it’s not an HIV test).

Is it feasible to use this test in limited resource settings?

29

Clinical Need

Standard tests to monitor CD4 levels in HIV+ patients require flow cytometry. The equipment is expensive and difficult to maintain, so the test is expensive.

Patients may need to travel an entire day for a medical appointment, so locating medical testing outside of major cities has potential to improve care.

30

Staff from University of Manitoba will conduct the device validation study at the University of Nairobi.

Is a two-tiered funding mechanism involved?

Points to consider…

• How many funding tiers are needed to execute the project plan?

• Will your funding agency allow a sub-to-sub relationship?

Know the limitations set by your funding agency

The Kenya Aids Control Project (KACP) of the University of Manitoba is hosted by

the University of Nairobi.

Funds flow through KACP to pay the University of Manitoba staff working on site at the University of

Nairobi.

The study will involve the use of de-identified and discarded specimens from human subjects.

36

In this case study, which institution is…

…responsible for obtaining IRB approval?

…allowed full recovery of indirect costs?

…required to have a Federal Wide Assurance (FWA) number?

…required to have a DUNS number?

…required to have an EIN number?

IRB approval is required from all three institutions -

PATH

U of Manitoba

Kenyatta Hospital

(U of Nairobi)

• All three institutions are required to have an FWA number.

• All three institutions are required to have a DUNS number.

• If a foreign institution will be paid via electronic funds transfer, it is required to have an EIN number.

REGISTRATIONS

40

Indirect cost limits are agency specific…

NIH/NIBIB honors PATH’s Negotiated Indirect Cost Recovery Agreement (NICRA), but limits foreign entities to an 8% indirect cost rate

CASE STUDY #2: Ultra Rice - School feeding program in Bujumbura, Burundi

Funding Source: United States Department of Agriculture (USDA)

National Institute of Food and Agriculture (NIFA)

Food Aid Nutrition Enhancement Program (FANEP)

Ultra Rice in Burundi

Some 2 billion people around the world, mainly women and children, suffer from iron deficiency—the most common and debilitating nutritional disorder

43

Different funding agency, different rules

USDA NIFA FANEP • Does not fund overhead for foreign institutions

• Prime awardee flows down award terms; sub-to-sub relationships are allowed

• The USDA references NIH policies

• Limited local resources

– Oversight of Burundi field work by Tanzania CRO

• Language differences

– Tanzania: English, Swahili

– Burundi: Kirundi, French

• Online communications

– Internet is available, but not reliable

– Not an email culture

– Time differences delay response time

• Teleconference challenges

– Face to face communications are valued more

– Consider expense

• Time difference require off-hour calls, sometimes to cell phones

• Electrical capacity

• Multiple IRB approvals

Project challenges

46

RESEARCH STUDY

Timeline, budget and scope are co-dependent.

CASE STUDY #3: Evaluation of a multiplexed HIV/syphilis test in Kisumu, Kenya

Funding Source: NIH - National Institute of Biomedical Imaging and Bioengineering

Case Study #3 – Kisumu, Kenya

WRAIR, KACP

Research Goal

Prototype test, still in development

Measures HIV and syphilis

Simple design, minimally instrumented, low cost

49

How does the test perform, compared to gold standard tests, in the hands of clinical lab technicians?

Clinical Need

Women in this setting may have their initial prenatal visit in the 3rd trimester.

Disease prevalence can be high in some populations.

Disease transmission to the baby causes harm and can be avoided if treatment is provided.

50

Test Development Considerations

We can measure accuracy of the test at PATH in Seattle, but how does it perform under, e.g. high temperature, humidity?

How much training is needed for a new user to get reproducible results?

How will the test be incorporated into existing clinical process?

51

Lessons Learned

• Subcontract PI – affiliation with Walter Reed Project

• 6 stages of ethical review – need to harmonize the study protocol

• Agreement type: CRADA

• Modes of communication, time zones

52

Summary

• Map out institutional and site affiliations

• Know funder’s grant management policy for work in foreign countries.

• Add buffers to budget and timelines; monitor and adjust next time.

• Hire staff who are good problem solvers.

53

Connecting all of the bridge segments…….

54

path: a catalyst for global health - duke university

Documents