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02244 WOMENS AUTONOMY AND INFORMED CONSENT IN MICROBICIDES CLINICAL TRIALS RESEARCH Woodsong, Cynthia* Internationally accepted principals of bioethics research include recognition of the autonomy of individuals to make decisions about participation in research, yet potential participants and community leaders in many research settings consider that enrolling women in microbicide trials without involving male partners potentially violates cultural norms. This paper presents data from two recent studies conducted in conjunction with a multi-national microbicides clinical trial (HPTN 035). These studies provide a range of views on participation in microbicide research, including the contentious issue of partner involvement. Data were collected from community leaders, health providers, and female and male research participants in 7 countries. In addition to considerations of the ethical principal of respect for persons, the host of issues surrounding partner involvement that were raised in the studies include (1) influence on adherence to study protocol, (2) forfeiting the potential for covert use, (3) distrust and/or lack of familiarity with the biomedical research process, and (4) access to trial care and treatment resources. The authors propose that adopting a comprehensive approach to the informed consent process can facilitate resolution of some of these issues, and this approach is summarized in the paper. Dr. Cynthia Woodsong, Senior Scientist |
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