Performance Improvement 2006. Evaluating the Efficacy of Informed Consent Forms and the Impact on Recruitment of Minorities into Clinical Research


This project provided a qualitative assessment of informed consent forms and their possible role as a barrier to the recruitment of minorities into clinical research, and attitudes and barriers to participating in research. Focus groups were conducted to assess attitudes and beliefs regarding participation in research, and assessing informed consent forms for plain language, comprehension, likelihood of participation,   and perception of costs/benefits. Eighty-one women participated. Themes included: trust in personal physicians, need for increased professionalism, and improved communication and cultural awareness. Minority women were more likely to express mistrust in researchers and the coded language of consent forms. Other women reported their views of the consent form as a license for researchers “to do whatever they want.” Additionally, women identified common words they did not understand used in many forms, and would be more likely to participate in research if certain convenience factors were met or their physician recommended it, and less likely to participate if the study included invasive procedures, side effects, or if there was a risk of being placed in a control group. RECOMMENDATIONS: Educate researchers regarding disparities and the purpose of research, and the use of peers and participants to describe their research experiences

PIC ID: 8240; Agency Sponsor: OPHS-OWH, Office of Women’s Health; Federal Contact: Newman, Eileen P., 301-443-1393; Performer: Drexel University - Med School NCE Women’s Health, Philadelphia, PA

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