Informed consent to HIV cure research.
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.
Department of Philosophy, University of Massachusetts Boston, Boston, Massachusetts, USA.
Danielle
D
Bromwich
Clinical Center Department of Bioethics/Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA.
Joseph R
JR
Millum
D035843:Biomedical Research / Q000941:ethics / Q000379:methods; D002986:Clinical Trials as Topic; D032882:Comprehension / Q000941:ethics; D003657:Decision Making / Q000941:ethics; D060740:Disease Eradication / Q000379:methods*; D028744:Ethics Committees, Research; D015658:HIV Infections / Q000517:prevention & control*; D058015:Health Communication / Q000941:ethics* / Q000592:standards; D057220:Health Literacy / Q000941:ethics; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D009042:Motivation; D010353:Patient Education as Topic / Q000941:ethics / Q000592:standards; D035842:Research Subjects; D018570:Risk Assessment
Decision-making; Ethics Committees/Consultation; HIV Infection and AIDS; Informed Consent; Research Ethics