摘要：Numerous diseases disproportionately affect African Americans across socioeconomic, age, gender, and geographic groups. Despite the need for research into these disparities, African Americans are often underrepresented in research. The Tuskegee Syphilis Study receives much of the blame for this problem, but other contributing factors have also been identified. To date, government policies seeking to increase African American participation have had limited success, and recently proposed changes to the Common Rule do not address this problem. Therefore, we have proposed 3 changes: treating racial minorities as vulnerable, requiring community consultation in minority research, and increasing minority representation on institutional review boards. Coupled with other efforts, these changes could help increase minority representation in researching health disparities. African Americans are disproportionately affected by numerous diseases and health problems, such as high blood pressure, diabetes, obesity, low birth weight, and AIDS, and these disparities persist across socioeconomic, age, gender, and geographic groups. 1–3 Although research is needed to formulate effective and appropriate public health programs to respond to these health disparities, African Americans are often underrepresented in research. 4,5 The mistrust engendered by the now infamous government-run Tuskegee Syphilis Study, which followed several hundred African American men with syphilis for 40 years, receives much of the blame for the underrepresentation of African Americans in research. 6 However, research abuses and African American mistrust of medicine did not start and end with the Tuskegee study. Stories of medical and research abuse circulating in the African American community date back to antebellum times. 7,8 More contemporary examples of questionable research involving African American populations include the EZ measles vaccine, 7 the Kennedy Krieger lead paint abatement, 9 and the polyheme synthetic blood 10 studies. Research has identified other factors besides mistrust that may account for underrepresentation, including provider biases and lack of access to care. 5 Despite disagreement about the exact causes of the problem, there is general agreement that the problem exists. 11 To date, government policies, such as the 1993 NIH Revitalization Act (Pub L 103–43; 42 USC 289a-1), which mandated inclusion of women and minorities in research, and researchers’ efforts to increase minority enrollment have had limited success. 12 The US Department of Health and Human Services 2011 Advanced Notice of Proposed Rule Making, which proposed several significant changes to the regulations governing human participant research for the first time in decades, 13 offered an opportunity to address the persistent underrepresentation of African Americans and other minorities in research; however, the US Department of Health and Human Services failed to address this important issue. We believe that systemic changes to the research oversight system are a necessary, but not sufficient, factor in increasing this enrollment. Accordingly, we suggest that future efforts to amend the regulations explicitly require inclusion of minority voices for research focused on minority health issues. As a beginning point for further discussion of possible regulatory changes, we recommend that the Common Rule treat racial minority populations as vulnerable, require community consultation as part of the institutional review board (IRB) process for research involving minority populations, and increase minority participation on IRBs that evaluate such research. We believe that these recommendations, coupled with other efforts—such as increasing the number of minority physicians and researchers and involving minority communities in developing research questions through methods such as community-based participatory research—could address some of the identified barriers to greater research participation of racial and ethnic minorities and thus facilitate the research that is needed on the health issues that disproportionately affect African Americans. The legacy of slavery, Jim Crow laws, and Tuskegee has focused researcher attention on health disparities and underrepresentation of African Americans in research. Accordingly, we frame our discussion in the context of the well-documented African American experience, recognizing that similar experiences support expanding our analysis to other minority populations.
