Family Health Ministries’ Research in Haiti

1. Why does Family Health Ministries believe that conducting research in Haiti is important?
2. What is an IRB?
3. What is the Misyon Santé Fanmi Ayisyen IRB?
4. Who are FHM’s research partners in Haiti?
5. FHM’s research manuscripts(link to manuscripts on this page)

FHM has learned that providing health care services that mimics the health care services in the United States does not always provide the most effective health care in other communities around the world. The best care is tailored to the specific needs of a community.

In June of 1993, the founders of Family Health Ministries were asked by Dr. Jean-Claude Fertillien to help him prevent cervical cancer in Leogane, Haiti. Through that partnership, we learned that:

• 20% of reproductive age females are infected with a cancer-causing virus called HPV (human papilloma virus)
• 3-5% of the women who request screening have an advanced untreatable cancer
• 85% of conventional Pap smears have obscuring inflammation, which prevents Pap smears from being an effective screening test
• by skipping Pap smears and going directly to colposcopy, physicians can identify 40% more treatable disease, which saves time, money and lives
• there are not enough pathologists in the country of Haiti to support a nationwide cervical cancer prevention program
• our research program was able to assist a corporate partner (Qiagen Corporation) develop an inexpensive test to identify the women who have a cancer causing virus, which can be used to help women all over the world
• the specific types of cancer-causing viruses in Haiti are different from the ones that cause cervical cancer in the United States, which makes the current vaccines manufactured in the US less effective in Haiti.

This example demonstrates that collecting and analyzing community health care data is necessary if the goal is to improve health care in countries like Haiti. This is research and this is an important component of FHM’s mission.

An institutional review board (IRB) is an ethics committee that reviews, approves, and monitors human subject research in order to protect the rights and welfare of the research subjects.

In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services / Office for Human Research Protections created regulations and guidelines (45 CFR 46) to help IRBs approve, modify, or disapprove research.

When an IRB makes a commitment to uphold the regulatory and ethical standards for conducting research according to the standards of the US Department of Health and Human Services / Office for Human Research Protections it is assigned a Federal Wide Assurance number.

The FHM IRB in Haiti was approved in June 2008 by the U.S. Department of Health and Human Services. The purpose is to allow Haitian experts to review and approve (or deny) FHM's clinical trials involving new technology to serve Haitian patients. There are six (6) Haitian members that are involved in the decision process, in addition to Dr. David Walmer, MD, Chairman of the FHM Board of Directors.

• Leon Dorleans, Pastor of Cité Soleil Church
• Sister Claudette Prevot, Fondwa Nun
• John Philogene-Nonez, Physician for FOSREF
• Renault Louissant, Attorney
• Delson Merisier, OB/GYN (Leogane)
• Kern Mathieu, Pediatrician

On June 10, 2008 FHM formed the Misyon Santé Fanmi Ayisyen IRB in Leogane, Haiti and made a commitment to uphold both regulatory and ethical standards for conducting human subject research in Haiti through a Federalwide Assurance issued by the federal Office for Human Research Protections (OHRP).

Misyon Santé Fanmi Ayisyen

• IRB Organization (IORG): 5476
• Federal Wide Assurance (FWA): 13290
• Institutional Review Board (IRB): 6585

Signatory Official

• Kathy Walmer, MSN

Human Protections Administrator

• Dr. Nicole Tinfo
   

The Misyon Santé Fanmi Ayisyen Institutional Review Board (MSFA IRB) is responsible for reviewing research involving human subjects in Haiti for Family Health Ministries. Currently, the MSFA IRB has oversight of 1 IRB located in Leogane, Haiti, which meets every 6 months.

All of Family Health Ministries’ research is also reviewed and approved by a registered IRB in the United States. FHM has submitted protocols to:
1) Western IRB,
2) Duke University Health System IRB,
3) Duke University IRB and the University of Florida IRB.

• Duke University Global Health Institute
• Qiagen Corporation
• University of Florida School of Public Health