Research directed toward an HIV cure presents ethical as well as scientific challenges.
International guidelines, regulations, and the medical literature provide helpful guidance on protecting research participants.
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.
aUniversity of California, San Francisco, California
bNational Institutes of Health, Bethesda, Maryland, USA
*Views expressed are those of the authors and do not necessarily reflect those of the Clinical Center, the National Institutes of Health, USA, or the U.S. Department of Health and Human Services.
Correspondence to Bernard Lo, MD, University of California, San Francisco, 103 Plaza Drive, Berkeley CA 94705, USA. E-mail: email@example.com