Bernard Lo1, Christine Grady. 1. University of California, San Francisco, California, USA. bernie@medicine.ucsf.edu
Abstract
PURPOSE OF REVIEW: Research directed toward an HIV cure presents ethical as well as scientific challenges. RECENT FINDINGS: International guidelines, regulations, and the medical literature provide helpful guidance on protecting research participants. SUMMARY: This review presents points to consider for researchers, sponsors, oversight committees, community advisory boards, and HIV advocates to help resolve ethical challenges that are particularly complex or difficult or that are not adequately addressed by current ethical guidelines. The points to consider are: collaborative partnership among international scientists from both the private and public sectors, as well as engagement of HIV-affected communities, social value, scientific validity, fair selection of participants and study sites, a favorable and acceptable risk-benefit balance, independent scientific and ethical review, informed and voluntary consent, and respect for enrolled patients and communities. To prevent therapeutic misconception, participants' comprehension of key features of the study may need to be assessed. Participants who suffer study-related adverse events should receive appropriate medical care and compensation. If interventions are shown capable of curing HIV, sponsors and international funding agencies should plan how to make them available and affordable in resource-poor countries.
PURPOSE OF REVIEW: Research directed toward an HIV cure presents ethical as well as scientific challenges. RECENT FINDINGS: International guidelines, regulations, and the medical literature provide helpful guidance on protecting research participants. SUMMARY: This review presents points to consider for researchers, sponsors, oversight committees, community advisory boards, and HIV advocates to help resolve ethical challenges that are particularly complex or difficult or that are not adequately addressed by current ethical guidelines. The points to consider are: collaborative partnership among international scientists from both the private and public sectors, as well as engagement of HIV-affected communities, social value, scientific validity, fair selection of participants and study sites, a favorable and acceptable risk-benefit balance, independent scientific and ethical review, informed and voluntary consent, and respect for enrolled patients and communities. To prevent therapeutic misconception, participants' comprehension of key features of the study may need to be assessed. Participants who suffer study-related adverse events should receive appropriate medical care and compensation. If interventions are shown capable of curing HIV, sponsors and international funding agencies should plan how to make them available and affordable in resource-poor countries.
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