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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.

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john e sidle m d february 23 2006

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
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
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
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
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 research1
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
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 participation1
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
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
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?
equity1
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)