The exposure of the details of U.S. Public Health Service (USPHS) 'Tuskegee Syphilis Study on Untreated Syphilis in the Negro Male' in national newspapers in 1972 is often cited as the most influential single force that directly led to the creation of Institutional Review Boards (IRBs) for the protection of human subjects in U.S. federally-funded studies. In its totality, The Tuskegee Legacy Project is a five Phase project (i.e. consists of 5 sequential, related but separate studies) with complementary qualitative and quantitative data collection elements. The basic concept of this investigation into 'whether and why' minorities (esp. African-Americans) are reluctant to participate in biomedical research studies is to utilize qualitative data gathering methods (focus group findings and expert interview findings) to guide the development of a quantitative instrument (a culturally-sensitive questionnaire) that will allow for a comparative study of this topic across African-Americans, Hispanics and Whites. Phase IV, as described in this NMOHRC grant application will be initiate in Year 04 of this grant, i.e. 1988. It will have both quantitative and qualitative components and will be characterized by the expansion of this project from a Northeast Regional study to a study of several selected regions of the U.S.. The qualitative component will consist conducting focus groups in these other regions of the U.S.; the quantitative component will consist of the final analysis and interpretation of the questionnaire data obtained in the Phase Ill study which will be completed by June 1988. Given the recent 1994 NIH guidelines on the inclusion of women and minorities in biomedical research, this project has significance for all biomedical researchers. This Phase IV study within the Tuskegee Legacy Project will continue a line of inquiry that has great relevance for minority health research projects, in general, and for our NMOHRC, in particular. Recruitment of adequate numbers of subjects into any clinical study is always challenging and often problematic. This would be compounded for the recruitment of African-American subjects if the 'guinea pig fear factor' legacy (regardless of whether it is, in fact, due to the Tuskegee Study, or--due to the broader societal realities for African- Americans over the last 200 years in the U.S.) has a measurable impact on enrollment attitudes of African-Americans vs Whites. This Phase IV study will provide data that will enhance understanding of the critical issues related to the recruiting of African-American research subjects.
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