 | The 131st Annual Meeting (November 15-19, 2003) of APHA |
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| The 131st Annual Meeting (November 15-19, 2003) of APHA |
Amy Corneli, MPH, CHES1, Margaret E. Bentley, PhD2, Ellen Piwoz, ScD3, James R. Sorenson, PhD4, Agnes Moses, MBBS5, Jacqueline Nkhoma5, and Charles M. van der Horst, MD6. (1) Health Behavior and Health Education, School of Public Health, University of North Carolina - Chapel Hill, 410 Fairoaks Circle, Chapel Hill, NC 27516, 919-960-8049, amycorneli@aol.com, (2) Nutrition, UNC-Chapel Hill, CB 7400, McGavran Greenberg, School of Public Health, Chapel Hill, NC 27514, (3) Academy for Educational Development, 1825 Connecticut Ave., NW, Washington, DC 2009, (4) Health Behavior and Health Education, University of North Carolina at Chapel Hill, Rosenau Hall, Chapel Hill, NC 27599, (5) UNC Project, Private Bag A-104, Lilongwe, Malawi, (6) School of Medicine, University of North Carolina @ Chapel Hill, 547 Burnett-Womack Building CB#7400, Chapel Hill, NC 27514
Obtaining informed consent in U.S.-funded international research is a challenge. Two areas of concern include participant understanding and individual consent. In 2002, a formative research study was conducted in Lilongwe, Malawi, to gather data from the community on issues surrounding study participation to inform a clinical trial on the safety and efficacy of antiretroviral and nutrition interventions to reduce mother-to-child transmission of HIV during breastfeeding. Data suggested the community had limited understanding of research concepts such that participants believed all medicines provided have already been tested to be safe and efficacious; they would be assigned to a study arm based on their individual health needs, not based on chance; and the clinical trial was designed to benefit them (therapeutic misconception). Participants also suggested the inclusion of husbands in the informed consent process and that community leaders be informed about the clinical trial. These data demonstrate the necessity of further investigation into participant understanding of research and into the social context in which participants are able to make choices and voluntary decisions about their health and the health of their infants. In this presentation, we will highlight the steps taken to develop a context-specific informed consent process for use in the clinical trial. This includes the conduct of additional formative research with health providers, HIV-infected women, and other members of the community; the translation of Western-based research concepts using local terms and meanings; and strategies for including the family and community in the informed consent process, while maintaining individual consent.
Learning Objectives:
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.