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

newUse of New Inclusion Management System Required as of October 17, 2014: Please see the following NIH Guide Notice for information on this topic:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-005.html

New System and Procedures for Reporting Sex/Gender, Race, and Ethnicity: Please see the following NIH Guide Notice for information on this topic: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-086.html

Transition Plans for Reporting Sex/Gender, Race, and Ethnicity information in Non-Competing Type 5 Progress Reports: Please see the following NIH Guide Notice for information on this topic:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-085.html

Changes to the inclusion enrollment reports: Please see the following NIH Guide Notice for information on this topic:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-092.html

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

Podcasts

Title

Format

Date

Length

Transcript

Including Women, Children, and Minorities in Clinical Research

MP3

April 6, 2011

14 min

Transcript

NIH's Inclusion Policy: Understanding Race and Ethnicity

MP3

July 26, 2013

7 min

Transcript

Additional Links