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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.
• 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, WoolsKaloustian, 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)