Evidence map›Paper›PMID 28984168›Full record

ArticleJournal of empirical research on human research ethics : JERHRE2018

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.

Karine Dubé, Lynda Dee, David Evans, Laurie Sylla, Jeff Taylor, Brandon Brown, Veronica Miller, Amy Corneli, Asheley Skinner, Sandra B Greene and 2 more

Abstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Karine Dubé1 UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
Lynda Dee2 AIDS Action Baltimore, MD, USA.
David Evans3 Delaney AIDS Research Enterprise Community Advisory Board, San Francisco, CA, USA.
Laurie Sylla6 defeatHIV CAB, Seattle, CA, USA.
Jeff Taylor7 Collaboratory of AIDS Researchers for Eradication, Palm Springs, CA, USA.
Brandon Brown8 University of California, Riverside, CA, USA.
Veronica Miller9 Forum for Collaborative HIV Research, Washington, DC, USA.
Amy Corneli10 Duke Clinical Research Institute, Durham, NC, USA.
Asheley Skinner1 UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
Sandra B Greene1 UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
Joseph D Tucker11 UNC Project China, Guangzhou, China.
Stuart Rennie13 UNC Center for Bioethics, Chapel Hill, NC, USA.

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Using NK Cells to eliminate the latent HIV reservoirU19AI096113 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI OTT, MELANIE MARIA · 2011 to 2015
$39.5M
Viral reservoirs and sanctuaries in HAART - treated patients: role and mechanismsU19AI096109 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PALMER, SARAH ELIZABETH · 2011 to 2015
$29.5M
Delaney AIDS Research Enterprise to Cure HIVUM1AI126611 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DEEKS, STEVEN GRANT, PICKER, LOUIS J. · 2016 to 2020
$27.9M
Cell and Gene Therapy for HIV CureUM1AI126623 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI JEROME, KEITH R, KIEM, HANS-PETER · 2016 to 2020
$24.2M
Collaboratory of AIDS Researchers for Eradication (CARE)UM1AI126619 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MARGOLIS, DAVID M. · 2016 to 2020
$23.2M
ZFN-Modified Stem Cells for HIV EradicationU19AI096111 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI KIEM, HANS-PETER · 2011 to 2015
$20.8M
Unintended and Intended Implications of HIV Cure: A Social and Ethical AnalysisR01AI108366 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RENNIE, STUART, TUCKER, JOSEPH DAVID · 2013 to 2017
$2.9M
NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI108366NIAID NIH HHS U19 AI096109NIAID NIH HHS U19 AI096111NIAID NIH HHS U19 AI096113NIAID NIH HHS UM1 AI126611NIAID NIH HHS UM1 AI126619NIAID NIH HHS UM1 AI126623
6 · The paper itself

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.

Indexed as

AttitudeHealth StatusResearch SubjectsAdministrative PersonnelAttitude of Health PersonnelBiomedical ResearchCost-Benefit AnalysisEthicistsEthics, ResearchHealthy VolunteersHIVHIV InfectionsHumansMoral ObligationsPhysiciansQualitative ResearchequipoiseHIV cure research“otherwise healthy volunteers”risk–benefit ratiosUnited States

Identifiers

PMID28984168
PMCPMC5768449

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.