Ethical Guidelines for Research

Ethical Guidelines for Research

http://www.hptn.org/ResearchEthics/HPTN_Ethics_Guidance.htm Back to the Rough Ground Community participation and ethics guidance for HIV prevention trials Kathleen M. MacQueen, PhD, MPH Family Health Intenational June 2003 HPTN Ethics Guidance for Research Kathleen M. MacQueen (FHI) Jeremy Sugarman (Duke University)

On behalf of the HPTN Ethics Working Group Quarraisha Abdool Karim (Chair), Ronald Bayer, Solomon R. Benatar, Marge Chigwanda, Dennis Dixon, Deborah Donnell, Laura Guay, Stella Kirkendale, Bernard Lo, Kathleen MacQueen, Sophia Mukaso Monico, Vasantha Muthuswamy, Katharine Shapiro, Ronald Strauss, Steve Wakefield, and Cynthia Woodsong HIV Prevention Trials Network Worldwide collaborative clinical trials network More than two dozen international sites Leadership group (FHI, FHCRC, Hopkins/Univ of

Pittsburgh) Develops and tests the safety and efficacy of non-vaccine interventions designed to prevent the transmission of HIV Established in 1999 by the DAIDS/NIAID/NIH

JHCCP Photoshare HPTN Working Groups Antiretroviral Therapy Behavioral Microbicides Perinatal STDs Substance Use Community Ethics Gary Lewis, JHU/CCP, South Africa 1999 HPTN Structural Challenges

Wide range of research > Flexibility Diverse local contexts > Responsive Collaboration > Procedural, not prescriptive Compatibility with existing HPTN & DAIDS procedures Prevention & public health perspective HPTN Ethical Challenges

What are acceptable standards of care? What are researchers responsibilities for moving research into policy & practice? How should stigma be dealt with? When are placebo controlled trials justified? How can informed consent be assured? Is research on new interventions ethical if existing knowledge is not being used?

HPTN Ethics Guidance for Research Participants and communities Obligations Process not prescription Do what is doable, achieve the achievable Creativity, persistence, partnership What is Community? A group of people with diverse characteristics who are linked by social ties, share common perspectives, and

engage in joint action in geographical locations or settings. MacQueen KM, et al. What is community? An evidence-based definition for participatory public health. AJPH 2001;91:19291938 Community Representation Representatives should be actively connected to diverse people in their local communities and empowered to function in ways that are meaningful to their community base.

A cookbook approach to participatory programs and research will not work because the experience of community differs from one setting to another. Each research collaboration must reconcile the differences and similarities among the participating communities. MacQueen KM, et al. What is community? An evidence-based definition for participatory public health. AJPH 2001;91:19291938 Participants / Communities Poor community health care Enhanced care for participants Beneficence

Two-tiered health system Disparity Inducement The Lucky Few The Unlucky Many Stigma? Brain drain? Sustainability? Participants + Communities Poor community health care

Partner to improve care Enhanced care for participants Beneficence Capacity building Equity Improved community health care Stigma?

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