Inclusion of Women and Minorities As Participants In Research Involving Human Subjects - Policy Implementation Page
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Inclusion of Women and Minorities as Participants in Research
Involving Human Subjects - Policy Implementation Page

The NIH is mandated by law (Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2) 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.

News Flash

Changes to the inclusion enrollment reports: Please see the following NIH Guide Notice for information on this topic:

Additional Guidance on the changes to the inclusion enrollment reports and how to report race and ethnicity to NIH:

Policy Documents, Contacts, and Forms

NIH Contacts

NIH Forms and Applications:

Application Instructions and enrollment 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.

FAQs and Outreach Materials







Including Women, Children, and Minorities in Clinical Research


April 6, 2011

14 min


NIH's Inclusion Policy: Understanding Race and Ethnicity


July 26, 2013

7 min


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  • This page last updated on February 5, 2014
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