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133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA |
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Ana Núñez, MD, Candace Robertson, MPH, and Eve Mitchell, MPH, CHES. Women's Health Education Program, Drexel University College of Medicine, 2900 Queen lane, Phialdephia, PA 19129, 215-99-8450, croberts@drexelmed.edu
Problems in recruitment and retention of minority women in clinical trials contributes to health disparities in disease prevalence, access to care and treatment outcomes for women, ethnic, and racial minorities. This project provides a qualitative assessment of informed consent forms (ICF.) The aims of the analysis were to evaluate: 1) their potential role as a barrier to the recruitment of minorities into clinical research and, 2) participants attitudes and perceived barriers to participation. METHODS: Multiple focus groups were conducted to assess attitudes and beliefs regarding participation in research and to evaluate informed consent forms for plain language, comprehension, likelihood of participation and perception of costs/benefits. RESULTS: In the preliminary analysis of the eighty one African American, Latina, and Caucasian women participants, prominent themes included: trust in physicians, need for increased professionalism, improved communication and cultural awareness. Minority women were more likely to express mistrust in researchers and the coded language of consent forms. Other views of ICFs, once signed, was that it allowed researchers “to do whatever they want.” Additionally, women identified words commonly used (e.g. subject, placebo) they did not understand. Women reported factors conducive to participating in research as: certain convenience factors, personal physician recommendation and sense of ‘community' in research setting. Factors that were a disincentive were: invasiveness; side effects; or, risk of being placed in a control group. CONCLUSIONS: Barriers to minority woman participation in clinical trials exist in the consent process. These barriers are addressed through systematic changes in the process and forms.
Learning Objectives:
Keywords: Women's Health, Research
Presenting author's disclosure statement:
I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.
The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA