The NIH is mandated by law (NIH Revitalization Act of 1993, PL103-43) to ensure the inclusion of women and minority groups in clinical research. The goal is to ensure that individuals are included in clinical research in a manner that is appropriate to the scientific question under study.

Policy Documents, Contacts, and Forms

• Policy Documents:
• 10/09/2001 NIH Guide Notice - The NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research was amended October 2001.
• Click here for a complete copy of the Amended Policy that provides full explanation of the October 2001 policy notice.
• NIH Policy on Reporting Race and Ethnicity Data for Subjects in Clinical Research
• NIH Contacts (MS Word - 54 KB) - Updated March, 2012
• NIH Forms and Applications- Application Instructions, forms and enrollment tables formats for addressing the Inclusion Policy in the PHS 398, SF424 (R&R), etc. The instructions are contained within the Human Subjects Section of the Research Plan.
  • Note: NIH-Defined Phase III Clinical Trials have additional requirements regarding plans for valid analysis by sex/gender and race/ethnicity.
  • Targeted/Enrollment Table (in the SF424 and PHS 398 forms) and Enrollment Table (see PHS 2590 forms)
    • PDF versions: Target/Planned Enrollment Table (PDF - 329 KB) and Inclusion Enrollment Reports (PDF - 604 KB)

FAQs and Outreach Materials

• Inclusion Policy FAQ
• FAQ on Reporting Race and Ethnicity
• Outreach Notebook and FAQ from the Office of Research on Women's Health
• Sex/Gender and Minority Inclusion in NIH Clinical Research: What Investigators Need to Know! (11/21/2002) - A PowerPoint slide set with highlights of the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research, as well as the 1997 OMB standards for collecting and presenting data on ethnicity and race.

Additional Links

• Office of Research on Women's Health -This site includes reports on monitoring adherence to NIH policy on inclusion of women and minorities as subjects in clinical research beginning with Fiscal Year 1997 data.
• National Institute of Minority Health and Health Disparities
• Inclusion of Children in Research Policy Page
• The Science of Sex and Gender in Human Health Online Course Web Site - This site was developed by NIH and FDA for researchers, clinicians, and members of academia to gain a basic scientific understanding of the major physiological differences between the sexes, the influences these differences have on illness and health outcomes, and the implications for policy, medical research, and health care. Continuing medical education credit is available for physicians

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