Research into a functional cure for HIV in neonates: the need for ethical foresight

Shah, Seema K.; Persaud, Deborah; Wendler, David; Taylor, Holly A.; Kruger, Mariana; Grady, Christine

doi:10.1016/s1473-3099(14)70766-2

Cited by 20 publications

(19 citation statements)

References 34 publications

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“…3 They offer ethical points to consider that focus attention on considerations of study design, participant recruitment, and implementation. 4 Several authors highlight the need to balance assessment of risks and benefits, including special dilemmas raised by recruiting neonates into clinical trials, 5 and possible shifting assessments that may be required when fairly healthy individuals are recruited to trials with uncertain and in some cases serious risks. 6,7 Finally, a number of authors [7][8][9] comment on the importance of language and the power of the word ''cure.''…”

Section: Introductionmentioning

confidence: 99%

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

Henderson

2015

AIDS Research and Human Retroviruses

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The advent of HIV ''cure'' research has generated enormous attention, but also concern about its potential to engender false hope, leading to overestimation of benefits and underestimation of risks, and about recruiting relatively healthy participants to studies with uncertain or serious risks. Currently, little is known about potential ethical problems in the ways that informed consent for HIV cure research is described to potential participants. As a first step to address this question, early phase, HIV ''cure'' research consent forms were analyzed to assess how study aims and potential risks and benefits are presented. Thirteen consent forms from a diverse group of clinical studies were selected to represent the major categories of cure research, including 11 interventional (gene transfer, vaccine intensification, treatment interruption, and latency reversing) and two observational. Consent forms were coded using seven categories, abstracting data on study purpose and design, participant selection criteria, presentation of risks and benefits of participation, and potential return of research results. Findings demonstrate variation and deficiencies that merit attention, but that can largely be addressed by turning to existing guidance about early phase research and specific study designs from other research contexts. The most challenging of these is ensuring that clear, specific, and consistent language is used to describe study aims, risks, benefits, and possible return of results. Informed consent for HIV ''cure'' research represents an opportunity to apply relevant existing guidance, measure the effectiveness of its application, and develop standardized best-practice policies for consent forms and processes.

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Section: Introductionmentioning

confidence: 99%

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

Henderson

2015

AIDS Research and Human Retroviruses

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“…Attention is now focussing on the ethics of HIV cure clinical trials, with early discussions focusing on therapeutic misconception, risk-benefit ratio and study design (Lo & Grady, 2013; Persaud et al, 2013; Shah et al, 2014). However, to truly inform these discussions, an understanding of HIV infected patients’ knowledge of cure research, their expectations from participating in such research and any factors which may impact their ability to give informed consent is essential.…”

Section: Introductionmentioning

confidence: 99%

HIV cure research in South Africa: a preliminary exploration of stakeholder perspectives

et al. 2015

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Progress in HIV research has led to the development of innovative strategies for HIV cure so that patients can be disease free in the absence of antiretroviral therapy. Consequently research studies are being designed and planned globally. South Africa is no exception. However little is known about stakeholders’ knowledge, understanding and expectations of future cure research. This study aimed to obtain in depth qualitative insights into stakeholder perspectives at this formative stage of HIV cure research in South Africa. We interviewed 15 stakeholders in a busy HIV research clinic in the Western Cape, South Africa. This purposive sample comprised patients, community advisory board (CAB) members, research nurses, doctors, counsellors and a project manager. All participants provided informed consent. Interviews were transcribed verbatim and analysed using thematic content analysis. The study was approved by the Health Research Ethics Committee at Stellenbosch University. Broad themes that emerged included the meaning of cure, awareness of HIV cure research, risks and benefits of such research. General awareness and understanding of HIV cure research was lower than expected. Healthcare workers interpreted “cure” to mean complete eradication of virus from the body including from reservoirs while patients’ perceived cure to be a return to normality with no need for future medication. Some participants expressed a fatalistic attitude to the disease and described HIV as an “end-time illness” with no prospect of cure. In general, HIV cure research was regarded as risky - biologically psychologically and socially. If study designs were to include treatment interruption, participants would comply only if there was a guarantee of success. Given these perceptions of HIV cure research, significant challenges to consent processes and participant recruitment can be anticipated for proposed trials in South Africa. Authentic community engagement and intensive educational interventions will be necessary prior to future cure research in the country.

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“…9–13 A third candidate solution is developing firmer study safeguards such as explicit contingency plans for adverse events, including, in cure and remission studies, guidelines for ART discontinuation and restarting if needed. 14 A fourth one is to defer experimenting with riskier cure strategies or wait for the development of safer alternatives to their relatively toxic components of cure interventions (such as immunosuppressive drugs), 15 starting instead with other cure and remission strategies. A fifth one is using as much as possible observation of precedents created by fluke or inappropriate care, as may have happened in some cases.…”

Section: Risksmentioning

confidence: 99%

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

Eyal

2016

J Med Ethics

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This article lays out a wide spectrum of candidate ethical solutions for the challenge that is at the topic of this JME symposium: the benefit/risk ratio challenge to some early-phase HIV cure and remission studies. These candidate solutions fall into four categories: ones that seek to reduce risks in early-phase HIV cure and remission studies; ones that enhance the benefits for these studies’ participants (or show that those were adequate in the first place), ones that focus on participants’ free and informed consent to participate, and ones according to whom the large benefits to nonparticipants can defeat considerations about individual participant net risks. In so doing, this article also structures the rest of the symposium.

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Research into a functional cure for HIV in neonates: the need for ethical foresight

Cited by 20 publications

References 34 publications

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

HIV cure research in South Africa: a preliminary exploration of stakeholder perspectives

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

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