Inclusion of Women and Minorities as Participants in
Involving Human Subjects - Policy Implementation Page
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:
- NIH Contacts (MS Word - 59 KB) - Updated April, 2013
- 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)
FAQs and Outreach Materials
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.