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

• Frequently Asked Questions – Outreach Notebook: Inclusion of Women and Minorities in Clinical Research
• Frequently Asked Questions on Reporting Race and Ethnicity

Additional Links

• NIH Office of Research on Women's Health
  • The Science of Sex and Gender in Human Health Online Course
• National Institute of Minority Health and Health Disparities
• Inclusion of Children in Research Policy Page

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