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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 decision-making; compensation; and autonomy especially with regard to womens 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. (excerpt)

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