Ethical issues in HIV remission trials

Eyal, Nir; Holtzman, Lisa; Deeks, Steven G.

doi:10.1097/coh.0000000000000489

Cited by 25 publications

(19 citation statements)

References 44 publications

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“…Scalability Considerations : Bioethicists, researchers, and community members have recognized that scalability of interventions is potentially a key factor by which to judge the social value of HIV cure research strategies [ 3 , 7 , 28 , 29 , 45 , 65 , 66 ]. This aligns with the rationale for advancing translational research related to an HIV cure [ 45 , 67 , 68 ].…”

Section: Discussionmentioning

confidence: 99%

“…Use of Placebos : As in other research settings, determining the ethical and scientific appropriateness of placebo-controlled trials in HIV cure research can be complex [ 7 , 9 ]. After extensive deliberation, a multi-disciplinary group of HIV cure experts concluded that placebo arms should be used where necessary and appropriate to confirm scientific validity of trials [ 9 ].…”

Section: Discussionmentioning

confidence: 99%

“…While promising, such research is associated with a range of ethical considerations [ 6 , 7 ]. Akin to other early phase research, there have generally been asymmetric benefit/risk profiles in early-phase HIV cure research, with individual research participants bearing the clinical and psychosocial risks while science and society almost solely reaping the benefits [ 7 , 8 ]. This is particularly the case for research involving risky study procedures, such as analytical treatment interruptions (ATIs) where ART is paused during the research.…”

Section: Introductionmentioning

confidence: 99%

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Ethics of HIV cure research: an unfinished agenda

et al. 2021

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Background The pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research. Methods We conducted a scoping review of the growing HIV cure research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing. Discussion Despite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation). Conclusion HIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly advance, ethical considerations of the major themes we identified will need to be revisited and refined over time.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Ethics of HIV cure research: an unfinished agenda

et al. 2021

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“…Moreover, scalability of Interventions will be a critical Integrative BSSR topic that will determine the societal value of HIV cure regimens . Better knowledge about cost‐effectiveness and performance benchmarks (i.e.…”

Section: Discussionmentioning

confidence: 99%

Applying the Behavioural and Social Sciences Research (BSSR) Functional Framework to HIV Cure Research

et al. 2019

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Introduction The search for an HIV cure involves important behavioural and social processes that complement the domains of biomedicine. However, the field has yet to tap into the full potential of behavioural and social sciences research (BSSR). In this article, we apply Gaist and Stirratt’s BSSR Functional Framework to the field of HIV cure research. Discussion The BSSR Functional Framework describes four key research domains: (1) basic BSSR (understanding basic behavioural and social factors), (2) elemental BSSR (advancing behavioural and social interventions), (3) supportive BSSR (strengthening biomedically focused clinical trials), and (4) integrative BSSR (building multi‐disciplinary combination approaches for real‐world implementation). In revisiting and applying the BSSR Functional Framework, we clarify the importance of BSSR in HIV cure research by drawing attention to such things as: how language and communication affect the meaning of “cure” to people living with HIV (PLHIV) and broader communities; how cure affects the identity and social position of PLHIV; counselling and support interventions to address the psychosocial needs and concerns of study participants related to analytical treatment interruptions (ATIs); risk reduction in the course of ATI study participation; motivation, acceptability, and decision‐making processes of potential study participants related to different cure strategies; HIV care providers’ perceptions and attitudes about their patients’ participation in cure research; potential social harms or adverse social events associated with cure research participation; and the scalability of a proven cure strategy in the context of further advances in HIV prevention and treatment. We also discuss the BSSR Functional Framework in the context of ATIs, which involve processes at the confluence of the BSSR domains. Conclusions To move HIV cure regimens through the translational research pathway, attention will need to be paid to both biomedical and socio‐behavioural elements. BSSR can contribute an improved understanding of the human and social dimensions related to HIV cure research and the eventual application of HIV cure regimens. The BSSR Functional Framework provides a way to identify advances, gaps and opportunities to craft an integrated, multi‐disciplinary approach at all stages of cure research to ensure the real‐world applicability of any strategy that shows promise.

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“…This impact can be substantial and raise ethical quandaries, as two recent examples illustrate. Participants in ongoing HIV curerelated studies with an interruption of antiretroviral therapy may transmit the virus to fetuses and sexual partners when HIV concentration in body fluids increases after that interruption (4). A report by a US National Institute of Allergy and Infectious Diseases planning committee recently recommended against challenge studies for Zika vaccine candidates in part because such studies would risk transmission to fetuses, sexual partners, and even people bitten by the same mosquitos who bit study participants (5).…”

Section: Risks To Research Bystandersmentioning

confidence: 99%

Risk to study nonparticipants: A procedural approach

Eyal

Lipsitch

Bärnighausen

et al. 2018

Proc. Natl. Acad. Sci. U.S.A.

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Current ethical guidance for research on human subjects is primarily concerned with protecting study participants.* They are, after all, the "human subjects" whose interests are the focus of oversight. But researchwhether on human subjects or not-may also strongly affect individuals who are not study participants. US law defines study participants as living people about whom data are obtained through intervention or interaction or about whom identifiable private information is collected (1). Many individuals about whom no data are obtained through intervention, interaction, or other means can be affected by a study. A complex ethical question therefore arises. What protections are owed to study nonparticipants? Except in the case of fetuses (a relatively complex case in light of their debatable moral status), US law governing all federally funded research does not address risk to nonparticipants (1). Although guidance exists Research on human subjects can affect people other than the subjects. What protections are owed to study nonparticipants? Image courtesy of Dave Cutler (artist).

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Ethical issues in HIV remission trials

Cited by 25 publications

References 44 publications

Ethics of HIV cure research: an unfinished agenda

Ethics of HIV cure research: an unfinished agenda

Applying the Behavioural and Social Sciences Research (BSSR) Functional Framework to HIV Cure Research

Risk to study nonparticipants: A procedural approach

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