studies be designed to allow valid analyses to be performed (i.e., to detect a significant difference that is of clinical or public health importance on the basis of scientific data). Investigators are required to report on actual accrual and inclusion of women and minorities in progress reports and for supplementary grant applications. In the future, reporting on intent to recruit will also be mandated. A computerized tracking system that enables NIH institutes to report on the actual number of ethnic minorities and women included in NIH-sponsored research studies has been developed.

The NIH Revitalization Act did not, however, address the many practical and ethical concerns that affect recruitment of ethnic minorities into clinical trials. As noted above, the cost of research may vary, with some populations being more costly to recruit into clinical trials. Balancing cost considerations with the need for fair recruitment into clinical trials can be challenging and can involve trade-offs that constrain researchers. Another concern is the applicability of results of studies with the general population to each of the relevant subpopulations. If certain groups of individuals are not included in clinical trials, then the principle of justice would support the need for a remedy to this situation. This leads to a separate concern: whether it is ethical to target the recruitment of ethnic minorities into clinical trials. Targeted studies are based on the conceptual framework that individuals differ on the basis of gender, "race" or ethnicity, culture, age, and other factors. However, these studies also raise the concern that the researchers who are involved in these studies believe that there are biological differences among the "races," a concept that is controversial (see Chapter 2). In certain cases, such assumptions that individuals differ are reasonable, such as in the evaluation of biological differences in the context of genetic conditions or in behavioral studies, especially if the behavioral studies address institutional racism that is associated with outcome differences between ethnic minorities and nonminorities. Finally, trust is an important consideration in recruitment efforts. Much existing evidence indicates that African Americans are less trusting of clinical research efforts than whites. No data are available indicating whether low-income whites share this mistrust. These concerns are not unreasonable, given the large degree of evidence indicating the lower intensities of medical and surgical care for African Americans.

NIH Efforts to Increase Participation of Minority and Medically Underserved Groups in Clinical Trials

The National Cancer Institute (NCI) has reported on several initiatives that have been used to increase the participation of ethnic minority populations and groups with low levels of literacy in clinical trials.

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