• Report

Informed Consent in HIV Prevention Trials: Report of an International Workshop


McGrory, C. E., Friedland, B., Woodsong, C., & MacQueen, K. (2006). Informed Consent in HIV Prevention Trials: Report of an International Workshop. New York, NY: Population Council.


The Population Council and Family Health International cohosted an international workshop on 16–18 May 2005, focusing specifically on the informed consent process in HIV prevention trials. To facilitate learning among participants with diverse backgrounds and approaches, the meeting blended experience from ongoing and planned clinical trials with theoretical underpinnings in areas like risk perception, adult learning theory, and bioethics.

The workshop drew together more than 70 participants from 11 countries and varied backgrounds: representatives from research institutions, trial sponsors and advocacy groups; donors; principal investigators and clinic staff; social scientists; and experts in related fields. A third day was targeted to a subset of participants directly involved with developing materials and implementing the informed consent process. (See Table 1 on page 4 for a complete list of the trials represented.)

Workshop participants enjoyed a rich and lively set of presentations and discussions on key practical and conceptual issues concerning informed consent. Many participants shared their experiences with the dynamic and sometimes frustrating processes of developing materials, designing and implementing new procedures, conducting assessments, and advocating for the importance of attention to informed consent within complex trial and community contexts.

This report captures the main topics discussed at the workshop. The first section reviews the historical and regulatory foundations of informed consent. The next section touches on several among myriad factors that influence informed consent: contextual issues; risk perception and decisionmaking; compensation; and autonomy, especially with regard to women's participation in clinical trials. A related discussion follows concerning the central role that communities can play in informing research processes as well as influencing individual decisions. The main section of the report explores a range of practical issues related to developing and using tools to enhance the informed consent process and is followed by a discussion of how best to assess the effect that all these efforts have on participants' comprehension. These sections, in particular, incorporate examples from completed and existing clinical trials to illustrate concrete opportunities and challenges associated with this process. The final section reviews results and strategies for evaluating informed consent processes. The report ends with recommendations for further consultation and research on this issue.

The workshop underscored the dynamic and creative way that clinical trial sponsors and investigators, clinic staff, social science researchers, donors, and communities are approaching the challenge of informed consent in these complex and critical trials. Participants left the workshop charged with new ideas and approaches to bring to their work and committed to identifying opportunities for ongoing collaboration. Addressing these compelling issues is central to the ethical and practical implementation of this critically important research.