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J Empir Res Hum Res Ethics. 2018 Feb;13(1):3-17. doi: 10.1177/1556264617734061. Epub 2017 Oct 6.

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.

Author information

1
1 UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
2
2 AIDS Action Baltimore, MD, USA.
3
3 Delaney AIDS Research Enterprise Community Advisory Board, San Francisco, CA, USA.
4
4 amfAR Institute for HIV Cure Research CAB, San Francisco, CA, USA.
5
5 Project Inform, San Francisco, CA, USA.
6
6 defeatHIV CAB, Seattle, CA, USA.
7
7 Collaboratory of AIDS Researchers for Eradication, Palm Springs, CA, USA.
8
8 University of California, Riverside, CA, USA.
9
9 Forum for Collaborative HIV Research, Washington, DC, USA.
10
10 Duke Clinical Research Institute, Durham, NC, USA.
11
11 UNC Project China, Guangzhou, China.
12
12 UNC Institute of Global Health and Infectious Diseases, Chapel Hill, NC, USA.
13
13 UNC Center for Bioethics, Chapel Hill, NC, USA.

Abstract

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.

KEYWORDS:

HIV cure research; United States; equipoise; risk–benefit ratios; “otherwise healthy volunteers”

PMID:
28984168
PMCID:
PMC5768449
[Available on 2019-02-01]
DOI:
10.1177/1556264617734061

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