Women's autonomy and informed consent in international microbicide clinical trials

Abstract

Achieving respect for persons is problematic in settings with concepts of autonomy that differ from Western values. For international research, women's autonomy to consent to participation is an increasingly contentious issue. We present data from ancillary studies conducted in preparation for a clinical trial testing the safety and efficacy of topical microbicides, used to prevent HIV infection. These ancillary studies were conducted in seven countries, using qualitative research methods to collect data from female and male community members, and their health care professionals and community leaders. Our findings indicate that by working at the level of the community, couple and individual, researchers may be able to take steps to increase women's ability to make their own independent decisions about participating in research. This approach may, in turn, improve both the conduct and outcomes of research.