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Cynthia Woodsong, PhD and Quarraisha Abdool Karim, PhD

Cynthia Woodsong is with Family Health International, Research Triangle Park, NC. Quarraisha Abdool Karim is with the Centre for the AIDS Programme of Research in South Africa and the Division of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY.

Correspondence: Requests for reprints should be sent to Cynthia Woodsong, PhD, Family Health International, PO Box 13905, Research Triangle Park, NC, 27709 (e-mail: cwoodsong{at}fhi.org).

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health.

This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment.

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