Bioethics Blogs

HIV Cure Research and The Dual Aims of the Informed Consent Process

Guest Post: Danielle Bromwich and Joseph Millum

Paper: Informed Consent to HIV Research 

Special Issue: The benefit/risk ratio challenge in clinical research, and the case of HIV cure

A cure for HIV would be tremendously valuable. Approximately 37 million people worldwide are HIV-positive and 15 million are currently on antiretroviral therapy. Until recently it was assumed that this therapy would be the extent of HIV treatment and that those with access to it would need to take their drugs for life. But what once seemed impossible is now in early phase clinical trials: interventions designed to completely eradicate HIV from the immune system.

Excitement surrounding these “HIV cure” studies is tempered by ethical concern. They require participants to come off their antiretroviral therapy and undergo highly risky interventions using gene transfers or stem cell therapy. These are currently proof of concept studies—no one expects the participants to be cured. Their purpose is to provide essential information about safety and pharmacokinetics, but in doing so they expose participants to high risks with little prospect of direct benefit.

If we could be confident that participants understood their trials’ true risk-benefit ratio, these high risks might be less troubling. But such confidence would be misplaced. Decades of data show poor comprehension of risk among participants in clinical trials. The fact that HIV is still a stigmatized condition amplifies this concern. Potential participants may be desperate to be rid of their disease and so downplay the risks and exaggerate the potential benefits. Understandably, HIV cure researchers and research ethics committees are worried.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.