NIH Inclusion Policy: Women and Minorities in Clinical Research

Tier 1: Established: peer-reviewed research or government health authority
Publisher: U.S. National Institutes of Health (NIH) · Published: September 18, 2026 · Accessed: September 18, 2026

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Claims this source supports

• NIH is mandated by the Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2 to ensure the inclusion of women and members of racial and ethnic minority groups in all NIH-funded clinical research in a manner appropriate to the scientific question under study.
• The primary goal of the inclusion law is to ensure that research findings can be generalizable to the entire population.
• Federal statute requires clinical trials to be designed to analyze whether study outcomes differ for women and members of racial and ethnic minority groups.
• All NIH-funded studies meeting the NIH definition of clinical research must address plans for the inclusion of women and members of racial and ethnic minority groups; any exclusions based on sex, race, and/or ethnicity must include a rationale and justification based on a scientific or ethical basis.
• Scientific Review Groups assess each application as 'acceptable' or 'unacceptable' with regard to the inclusion of women in the research project.
• NIH recipients must collect and annually report information on sex, race, and ethnicity in progress reports.