office or clinic regularly, which for some entails transportation and child-care costs, which typically are not covered by federal research grants. Some research programs have offered meals as a means of assisting low-income patients' participation.

Thus, the combination of historical experience and unequal access to health care has created a dynamic of mistrust on the part of ethnic minority and medically underserved communities and, in many quarters, resignation to low levels of minority participation in clinical research among investigators and health practitioners.

From a scientific perspective, however, it is critical to include diverse populations in clinical trials to ensure that research findings are generalizable to the entire population. (As discussed in Chapter 4, Zora Kramer Brown provides an example of the dangers involved when scientists and public health officials attempt to generalize research findings from relatively homogeneous study populations to broad, more diverse populations.) From a social justice perspective, it is important that research supported by taxpayer dollars be inclusive of and applicable to the diverse populations of the United States.

To address these needs, NIH and the U.S. Congress worked to develop standards in the late 1980s and early 1990s that mandated the participation of women and ethnic minorities in federally supported human subjects research. In 1993, as part of the NIH Revitalization Act (P.L. 103–43), Congress passed legislation that called for (1) the inclusion of women, ethnic minorities, and subpopulations into clinical trials; (2) the inclusion of adequate numbers of women and ethnic minorities for performance of valid analyses; (3) preventing cost from being an applicable reason for the exclusion of these groups; (4) a determination of the circumstances under which inclusion of these groups may be inappropriate; and (5) clinical trials and outreach programs to be designed and executed in ways that encourage recruitment and retention of women and ethnic minorities (Penn, 1996). This legislation was designed to ensure that biomedical and behavioral research results are applicable to all affected populations and include detailed information about the effects of gender, racial, and socioeconomic factors that might influence the development and outcomes of cancer.

In response to the law, guidelines for inclusion were developed and published (US. Department of Health and Human Services, 1994), and a 1-year comment period was provided. The policy states that women and ethnic minorities and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects unless there is a clear and compelling justification that the inclusion of these groups is inappropriate with respect to the health of the subjects or the purpose of the research. NIH policy also demands that



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