Updates to NIH Inclusion Policy

When you prepare inclusion plans for your next applications or data for progress reports, review the updated Revision: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (NOT-OD-25-131), effective August 16, 2025 for both new and ongoing clinical research projects.

The policy remains substantially unchanged. As before:

• Women and members of racial and/or ethnic minority groups must be included in all clinical research studies unless there is a compelling rationale for their exclusion.
• NIH-defined phase 3 trials require valid analyses.
• Applicable phase 3 clinical trials must report results of valid analyses at ClinicalTrials.gov.

The revisions focus on terminology updates to align with HHS Sex-Based Definitions and Executive Order 14168. Inclusion plans and data reporting must consider and report on sex, race and/or ethnicity, and age.

Of note, the policy also mentions the federal race and ethnicity categories in the OMB Statistical Policy Directive No. 15 revision announced March 28, 2024. As discussed in the December 2024 Extramural Nexus article, award recipients should continue to report inclusion data to NIH using the 1997 categories until further notice.