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Informed consent to HIV cure research
  1. Danielle Bromwich1,
  2. Joseph R Millum2
  1. 1Department of Philosophy, University of Massachusetts Boston, Boston, Massachusetts, USA
  2. 2Clinical Center Department of Bioethics/Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA
  1. Correspondence to Dr Danielle Bromwich, Department of Philosophy, University of Massachusetts Boston, 100 Morrissey BLVD, Boston, MA 02125, USA; danielle.bromwich{at}


Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants' motivations for enrolling in potentially high risk research with no prospect of direct benefit; and third, participants' understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies.

  • Informed Consent
  • HIV Infection and AIDS
  • Decision-making
  • Ethics Committees/Consultation
  • Research Ethics

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  • DB and JRM contributed equally.

  • Disclaimer The ideas and opinions expressed are the authors' own. They do not represent any official position or policy of the U.S. National Institutes of Health or Department of Health and Human Services.

  • Contributors The authors jointly developed the argument, wrote, reviewed and revised the manuscript, and approved the final manuscript as submitted.

  • Funding National Institute of Allergy and Infectious Diseases (1 R56 AI114617-01). Clinical Center intramural funding.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.