International Research Ethics Experiences from Kenya in Bioethics : Equity, Informed Consent, and Community Participation in Research John E. Sidle, M.D. February 23, 2006

Background IUSM and Moi University School of Medicine in Eldoret, Kenya have had a partnership since Since 2001, the two universities have partnered in the Academic Model for the Prevention and Treatment of HIV/AIDS (AMPATH). AMPATH currently provides care to more than 20,000 HIV/AIDS patients with a goal of treating over 50,000 in western Kenya

Research Collaborative research began in 1999 Research projects have included medical informatics, bioethics, faculty development and evaluation, epidemiology, and health services research. Most current collaborative research focuses on HIV/AIDS and covers epidemiology, effective delivery of care, TB and HIV, medical informatics, clinical trials, and research ethics.

Research Oversight Collaborative research is reviewed at IU by the IRB In Kenya, MUSOM has an Institutional Review and Ethics Committee (IREC) that reviews protocols and provides ethical oversight to both local and collaborative research projects. The IREC holds an FWA with the Office of Human Research Protections (OHRP)

Ethics Research 2003—Shaffer,Tierney, Meslin, Greene, Yebei, Kimaiyo, Baliddawa, Sidle –Study of equity for patients participating in clinical trials. Examined the attitudes towards provision of post-trial benefits to patients involved in clinical trials –Consensus of decision-makers, researchers, and patients was that post-trial benefits should be provided (for life if possible, but for a minimum of 1-2 years post-trial)

Ethics Research —Meslin, Sidle, Wools- Kaloustian, Were, Chuani MOU established between the IRB and IREC to pursue cooperation in equity, informed consent, and Standard Operating Procedures This project involved a needs assessment for implementation of the MOU

Community Participation Individual identity and autonomy is not clear cut in Kenya. Part of a person’s identity derives from their standing and role as part of the community Proper involvement of community opinion leaders and “gatekeepers” is critical to the success of any community-based project

Community Participation Community meetings (barazas) are needed to gain input from council members, chiefs, elders, and other community opinion leaders (e.g. traditional birth attendants) Without the support of these leaders, many individuals will be unwilling to participate in the research Community leaders should assist in the design of research to be sure that it is in keeping with community mores and practices.

Informed Consent Verbal vs. written informed consent –Verbal consent culturally more appropriate, but written tends to be preferred by funders and Western researchers –How is informed consent handled when patient is illiterate, unfamiliar with the idea of research, is not fluent in English or Swahili Individual informed consent—who decides? –Community issues –Spousal issues

Equity Fair distribution of both benefits and risks across all groups –Patients: How do we provide fair benefits during or after a trial without giving undue inducement for participation? Is provision of community benefits sufficient, or must there always be benefits to the individual?

Equity –Researchers: How do benefits of conducting researchers compare between the team members (ie. salary, publications, promotion) –Institutions: Does each institution benefit in fair amounts from the research (e.g. indirect costs, equipment, infrastructure development)