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
Footnotes
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.
Request Permissions
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Copyright information:
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
- Do we really know how many clinical trials are conducted ethically? Why research ethics committee review practices need to be strengthened and initial steps we could take to strengthen them
- Problems and development strategies for research ethics committees in China ’s higher education institutions
- Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries
- Research ethics committees and paternalism
- What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics
- Emergency care research ethics in low - income and middle - income countries
- Reporting of ethical requirements in phase III surgical trials
- Trust based obligations of the state and physician - researchers to patient - subjects