Office of Research on Women's Health (ORWH)
Inclusion of Women and Minorities in Clinical Research
The establishment and implementation of policies for the inclusion of women and minorities in clinical research funded by the National Institutes of Health (NIH) has its origins in the women's health movement. Following the issuance of the report of the Public Health Service Task Force on Women's Health in 1985, the NIH established a policy in 1986 for the inclusion of women in clinical research. This policy, which urged the inclusion of women, was first published in the NIH Guide to Grants and Contracts in 1987. Later that year, minority and other scientists at the NIH recognized the need to address the inclusion of minority populations. Therefore, in a later 1987 version of the NIH guide, a policy encouraging the inclusion of minorities in clinical studies was first published.
In order to ensure that the policies for inclusion were firmly implemented by NIH, the Congress made what had previously been policy into Public Law, through a section in the NIH Revitalization Act of 1993 (PL 103-43), entitled Women and Minorities as Subjects in Clinical Research. In 1994, the NIH revised its inclusion policy to meet this mandate that women and minorities must be included in all of its clinical research studies. The Revitalization Act essentially reinforced the existing NIH policies, but with four major differences:
- NIH ensures that women and minorities are included in all human subject research;
- Phase III clinical trials inclusion of women and minorities in numbers adequate to allow for valid analyses of differences in intervention effect;
- Cost is not allowed as an acceptable reason for excluding these groups; and,
- NIH initiates programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as volunteers in clinical studies.
In 2001, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research were updated and incorporate the definition of clinical research as reported in the 1997 Report of the NIH Director's Panel on Clinical research and the Office of Management and Budget (OMB) Directive 15 racial and ethnic categories to be used when reporting population data. They also provide additional guidance on reporting analyses of sex/gender and racial/ethnic differences in intervention effects for NIH-defined Phase III clinical trials.