A Model Designed to Enhance Informed Consent: Experiences From the HIV Prevention Trials Network
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 resultedin increased attention to and discussion of ethical issues,particularly the issue of the quality of informed consent. Wepresent a conceptual framework for an enhanced informed consentprocess, drawing on experiences garnered from domestic and internationalstudies conducted by the HIV Prevention Trials Network, fundedby the National Institutes of Health.
This framework guides the development of an informed consentprocess designed to help ensure initial and continued comprehensionof research participation, with an emphasis on HIV preventionresearch. Attention is focused at the individual and communitylevels and on 3 study phases: preenrollment, enrollment, andpostenrollment.
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