Workshop on Informed Consent in HIV Prevention Trials

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DESCRIPTION (provided by applicant): Description, location and dates: The Population Council and Family Health International are convening a workshop on informed consent in clinical trials of HIV prevention technologies in developing countries. The three-day meeting will be held at the Population Council headquarters in New York City in the spring of 2005. Types of participants: Participants will include researchers implementing clinical trials (microbicides, vaccines, etc.); experts in risk communication, development and evaluation of behavior change communication (BCC) materials, and contraceptive introduction; members of organizations such as the International. AIDS Vaccine Initiative (IAVI), the Alliance for Microbicides Development, the Global Campaign for Microbicides, and the International Partnership for Microbicides (IPM); and key donors. Goals: Given the increasing number of HIV prevention trials planned or underway, and the ethical and practical challenges inherent in conducting these trials, it is critical to ensure that participants are truly informed and enroll voluntarily. Our goal is to review current practices and to outline recommendations for improving the informed consent process, including developing a framework for evaluation. Topics to be covered: We will review existing educational materials (booklets, flip-charts, videos), techniques for assessing comprehension (such as comprehension quizzes), and strategies for evaluating the materials and processes before and during the trials; explore ways in which the community can help (or hinder) the informed consent process; identify concepts that are typically problematic (such as placebo, randomization, and "partial effectiveness") and explore ways to improve communication about these.