Inclusion of Women and Minorities as Subjects in Clinical Research

Reprinted from the RSP Research News, Winter 2002 (p. 11)

It is a sad fact that, until recent policy changes, federally funded clinical studies have historically excluded women and minorities. This exclusion in essence created a male "norm" for health care practice and research. To illustrate the pitfalls of such a male "norm," we need only recall a study of the use of aspirin as a primary preventative for cardiovascular death in men. Women were initially excluded from the study group, and it was later demonstrated that aspirin was not an effective preventative for women and could actually harm them. Thus, it was discovered that it is not possible to effectively apply the male research model to women and minority groups who may react differently to drug therapies.

The National Institutes of Health (NIH) replied to these inequities by establishing the Office of Research on Minority Health and the Office of Research on Women’s Health. In response to the NIH Revitalization Act of 1993 (Public Law 103-43) the NIH in 1994 published its "Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research." By mandating this policy, NIH sought to ensure that women and members of minorities and their subpopulations were included in all NIH-supported biomedical and behavioral research involving human subjects. Of particular importance is the inclusion of women and minorities in Phase III clinical trials, the point at which the study drug or treatment is given to large groups of people to confirm its effectiveness.

The NIH has also made it clear in its policy that women and minority groups must be included as human subjects unless there is a "clear and compelling rationale" that their inclusion is "inappropriate with respect to the health of the subjects or the purpose of the research." Cost is not an acceptable rationale for exclusion, nor is barring women of childbearing potential. The policy applies to research subjects of all ages in all NIH-supported clinical research studies. (Note, however, that federal regulations continue to provide additional protections regarding the inclusion of pregnant women, neonates, and children in federally-funded research.)

The NIH has continued to refine its policy, issuing revisions in August 2000 and then again in October 2001. The latest amendments to the guidelines incorporate a more comprehensive definition of clinical research and provide additional guidance on reporting of any sex/gender and racial/ethnic differences during Phase III clinical trials. Researchers must ensure that they adequately address the issue of whether women, men or members of minority groups and their subpopulations are affected differently by interventions or therapies from NIH-funded clinical research.

These latest refinements to the NIH policy will not have a major impact on grant-funded Principal Investigators. PIs will continue to be expected to develop research plans that incorporate a diverse study population, and progress reports on Phase III clinical trials will have to analyze sex/ gender and racial/ethnic differences. The Wright State IRB will continue to ask all investigators proposing to involve human subjects in research to justify any exclusion of women and/or minorities, and will review other areas of the protocol to ensure minimal possibility of coercion in recruiting into or retaining participants in studies.

Ellen Reinsch Friese