Article Text
Abstract
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
Statistics from Altmetric.com
Read the full text or download the PDF:
Other content recommended for you
- Can informed consent to research be adapted to risk?
- Understanding, interests and informed consent: a reply to Sreenivasan
- Decision aids for randomised controlled trials: a qualitative exploration of stakeholders’ views
- Cross-sectional assessment of patient attitudes towards participation in clinical trials: does making results publicly available matter?
- Involving patients in enrolment decisions for acute myocardial infarction trials
- Fair subject selection in clinical research: formal equality of opportunity
- Complex calculations: ethical issues in involving at-risk healthy individuals in dementia research
- How to keep high-risk studies ethical: classifying candidate solutions
- Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment
- Relative importance of informational items in participant information leaflets for trials: a Q-methodology approach