How to keep high-risk studies ethical: classifying candidate solutions

Eyal, Nir

doi:10.1136/medethics-2016-103428

Cited by 15 publications

(14 citation statements)

References 27 publications

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“…Eyal suggests a spectrum of candidate solutions to address these concerns. 16 For example, one could argue that a well-informed person should be permitted to consent to a trial that might look like a ‘bad gamble’ given that as autonomous adults, they are permitted to engage in bad gambles in other domains of life. Second, one could also reduce the risks of the study, for example, through careful participant selection, extensive health monitoring and other safeguards.…”

Section: Introductionmentioning

confidence: 99%

Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment

et al. 2017

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Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study nested in a Thai acute HIV research cohort.In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks.These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach.

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Section: Introductionmentioning

confidence: 99%

Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment

et al. 2017

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“…Key stakeholders in the debate have maintained that some risks are too great to be acceptable, and others have argued that it is difficult to place a limit on acceptable risk because of the complexity of weighing risk‐benefit ratios in HIV research 25 . Still others point to the great potential for social good generated from allowing some to take substantial risks 26 …”

Section: Discussionmentioning

confidence: 99%

“…25 Still others point to the great potential for social good generated from allowing some to take substantial risks. 26 One way to answer the question about whether it is "rational" to be willing to take substantial risk for a cure is to consider our findings in the context of the "reasonableness" framework developed by philosopher Joel Feinberg. In his landmark book, Harm to Self, 27 Feinberg argues that while "prudence" may dictate that we take the less risky option when faced with a choice, prudence is not always reasonable.…”

Section: E R H E R Hmentioning

confidence: 99%

HIV Cure Research: Risks Patients Expressed Willingness to Accept

Kratka

Ubel

Scherr

et al. 2019

Ethics & Human Research

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Despite doing well on antiretroviral therapy, many people living with HIV have expressed a willingness to accept substantial risks for an HIV cure. To date, few studies have assessed the specific quantitative maximal risk that future participants might take; probed whether, according to future participants, the risk can be offset by the benefits; and examined whether taking substantial risk is a reasonable decision. In this qualitative study, we interviewed 22 people living with HIV and used standard gamble methodology to assess the maximum chance of death a person would risk for an HIV cure. We probed participants’ reasoning behind their risk‐taking responses. Conventional inductive content analysis was used to categorize key themes regarding decision‐making. We found that some people would be willing to risk even death for an HIV cure, and some of their reasons were plausible and went far beyond the health‐related utility of an HIV cure. We contend that people's expressed willingness to take substantial risk for an HIV cure should not be dismissed out of hand.

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“…The most obvious ethical response to a risk is to build in safeguards that reduce the hazard that any adverse event will occur or contain its consequences [ 19 – 21 ]. Many strategies have been proposed to reduce the risk faced by study participants.…”

Section: Proposed Ethical Responses To the Riskmentioning

confidence: 99%

Ethical issues in HIV remission trials

Eyal

Holtzman

Deeks

2018

Current Opinion in HIV and AIDS

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Purpose of reviewSeveral promising experimental pathways exist for long-term control of HIV in the absence of antiretroviral therapy (HIV ‘remission’) and are now being tested in early clinical studies. These studies can be invasive and pose a host of distinctive risks to participants, as well as to nonparticipants, especially to participants’ fetuses, and sexual partners.Recent findingsEthical analyses of these studies have mainly focused on the risks to study participants. They recommend, and some investigators implement, procedures to mitigate risks for participants or to offset them with direct, indirect, and nonmedical benefits. They also suggest ways to keep participants’ consent highly voluntary and informed. Rarely do ethicists propose keeping the social value of studies high. Of these recommended responses, only the latter, rarer proposals help address the risk to nonparticipants, as would some novel ways to address that risk.SummaryHIV remission studies pose a number of ethical dilemmas. Many current investigative approaches put the participant at significant risk, but well established guidelines exist for mitigating this risk. Ethical issues that are not being fully addressed include risk to nonparticipants and the need to consider the societal value of studies, for example, their prospective impact on the global HIV burden.Video abstract

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How to keep high-risk studies ethical: classifying candidate solutions

Cited by 15 publications

References 27 publications

Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment

Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment

HIV Cure Research: Risks Patients Expressed Willingness to Accept

Ethical issues in HIV remission trials

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