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 1989.

• 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

• 2004-2005—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)