Perceptions of Equipoise, Risk–Benefit Ratios, and “Otherwise Healthy Volunteers” in the Context of Early-Phase HIV Cure Research in the United States: A Qualitative Inquiry

Journal of Empirical Research on Human Research Ethics - Tập 13 Số 1 - Trang 3-17 - 2018
Karine Dubé1, Lynda Dee2,3,4, David Evans3,5, Laurie Sylla6, Jeff Taylor7, Brandon Brown8, Veronica Miller9, Amy Corneli10, Asheley Cockrell Skinner10,1, Sheila Greene1, Joseph D. Tucker11,12, Stuart Rennie13
1UNC Gillings School of Global Public Health, Chapel Hill, NC, USA
2AIDS Action Baltimore, MD, USA
3Delaney AIDS Research Enterprise Community Advisory Board, San Francisco, CA, USA
4amfAR Institute for HIV Cure Research CAB, San Francisco, CA, USA
5Project Inform, San Francisco, CA, USA
6defeatHIV CAB, Seattle, CA, USA
7Collaboratory of AIDS Researchers for Eradication, Palm Springs, CA, USA
8University of California, Riverside, CA, USA
9Forum for Collaborative HIV Research, Washington, DC, USA
10Duke Clinical Research Institute, Durham, NC, USA
11UNC Institute of Global Health and Infectious Diseases, Chapel Hill, NC, USA
12UNC Project China, Guangzhou, China
13UNC Center for Bioethics, Chapel Hill, NC, USA

Tóm tắt

Early-phase HIV cure research is conducted against a background of highly effective antiretroviral therapy, and involves risky interventions in individuals who enjoy an almost normal life expectancy. To explore perceptions of three ethical topics in the context of HIV cure research—(a) equipoise, (b) risk–benefit ratios, and (c) “otherwise healthy volunteers”—we conducted 36 in-depth interviews (IDIs) with three groups of purposively selected key informants: clinician-researchers ( n = 11), policy-makers and bioethicists ( n = 13), and people living with HIV (PLWHIV; n = 12). Our analysis revealed variability in perceptions of equipoise. Second, most key informants believed there was no clear measure of risk–benefit ratios in HIV cure research, due in part to the complexity of weighing (sometimes unknown) risks to participants and (sometimes speculative) benefits to science and society. Third, most clinician-researchers and policy-makers/bioethicists viewed potential HIV cure study participants as “otherwise healthy volunteers,” but this perception was not shared among PLWHIV in our study.

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Journal of Empirical Research on Human Research Ethics

Tập 13 Số 1

3-17

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