NIH Policies Involving Inclusion of Women

NIH is required by law (Public Health Service Act Section 492B, 42 U.S.C. Section 289a-2 (link is to an external PDF) (PDF, 128KB)), added by Section 101 of Public Law 103-43 on June 10, 1993 (link is to an external PDF) (PDF, 2.3MB), to ensure that women and minorities are included in all clinical research as appropriate to the scientific question under study. The law further requires that the design of a Phase III clinical trial must enable investigators to conduct a valid analysis of the differences in the effect of an intervention by sex and race/ethnicity if pertinent.

NIH has created guidelines and policies for applicants for NIH research grants, cooperative agreements, and contracts. These guidelines provide standards for assessing applications.