title: A model designed to enhance informed consent: experiences from the HIV prevention trials network.
abstract: 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.
authors.affiliation: Family Health International, PO Box 13905, Research Triangle Park, NC, 27709, USA. cwoodsong@fhi.org
authors.forename: Cynthia
authors.initials: C
authors.lastname: Woodsong
authors.forename: Quarraisha Abdool
authors.initials: QA
authors.lastname: Karim
mesh_terms: D000329:Advertising / Q000941:ethics / Q000592:standards; D003142:Communication; D003256:Community Participation; D032962:Consent Forms / Q000941:ethics / Q000592:standards; D018864:Cultural Diversity; D003479:Curriculum; D003906:Developing Countries; D017408:Guidelines as Topic; D015658:HIV Infections / Q000517:prevention & control*; D006805:Human Experimentation / Q000941:ethics / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000523:psychology / Q000592:standards; D017145:Models, Educational; D010353:Patient Education as Topic / Q000941:ethics / Q000379:methods* / Q000592:standards; D018579:Patient Selection / Q000941:ethics; D026684:Personal Autonomy; D035842:Research Subjects / Q000523:psychology; D035844:Researcher-Subject Relations / Q000941:ethics / Q000523:psychology; D013664:Teaching Materials / Q000592:standards
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