As stated in its guidelines, the NIH Outreach Notebook of the Inclusion of Women and Minorities in Biomedical and Behavioral Research (1994), the NIH has concluded that the inclusion of women in research is sufficiently important that the only justifiable reason to exclude non-pregnant women of child-bearing potential from research is a compelling rationale that the proposed project would be inappropriate with respect to the health of the subject or the purpose of the research.
The policy statement referenced above pertains primarily to the inclusion of women as subjects in clinical trials. However, investigators should also aspire to the inclusion of women in behavioral and other forms of research unless there is a compelling rationale that the inclusion is inappropriate regarding the health of the subject or the purpose of the research.
In addition to requiring the equitable selection of women as research subjects, federal regulations require the equitable selection of minorities as research subjects [45 CFR 46. 111(a)(3)]. The equitable selection of minorities in research is important both to ensure that they receive an equal share of the benefits of research and to ensure that they do not bear a disproportionate burden of the risks.