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

Abstract

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.

For love and money: the need to rethink benefits in HIV cure studies

“…Looking globally, it has been claimed that ‘there are usually no financial incentives’ for HIV cure trials 8. One study of consent documents for 13 HIV cure studies found a range from ‘no payment to nearly $2,000’, though neither the median nor mean payment was identified 9. Given that, as of early 2016, there were well over 100 HIV cure-related clinical studies either being conducted or already completed worldwide,10 it remains unclear what the average offer of payment is.…”

Immunogenicity of AGS-004 Dendritic Cell Therapy in Patients Treated During Acute HIV Infection

“…As two previously adherent participants became nonadherent after restarting ART, our findings suggest nonadherence following ATI should be addressed as a risk for participants. 36 Although immune responses induced by AGS-004 did not prevent rebound viremia off ART as an approach to functional cure, the finding that AGS-004 induced responses in all participants suggests AGS-004 might enhance clearance of virus-expressing cells in the setting of latency reversal in ART-suppressed individuals. Given ex vivo data suggest augmentation of HIV-specific immunity will be critical for HIV eradication, including one which reactivates latent HIV, 37 our findings indicate AGS-004 should be considered in future combined eradication strategies.…”

Informed consent to HIV cure research

“…It could also possibly cause cancer, or even spread to your reproductive organs and be passed on to any future children you may have. However, to date no such events have been reported … so this risk is still theoretical.”1 Despite his uncertainty, Darius trusts the medical center and believes in the project, so he signs the consent form and enrols in the trial.…”