Inclusion Across the Lifespan Policy

Section 2038(H) of the 21st Century Cures Act requires NIH to update guidelines for the inclusion of women and minorities in clinical research to reflect individuals of all ages included in NIH clinical research. Applicants should justify the proposed age range of the participants in clinical research, with specific attention to justifying the inclusion/exclusion of individuals of all ages (including children, defined as individuals under the age of 18, and older adults, defined as individuals 65 and older). Exclusions based on age must be scientifically or ethically justified. Applicants should report participants’ age of enrollment in progress reports.

For more information, please refer to NIH Guide Notice: This notice applies to all NIH applications submitted on or after January 25, 2019.

NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research

As required by federal law (42 USC 289a-2) and NIH policy, applications that propose to involve human subjects must address the inclusion of women, minorities, and children in the proposed research.

The NIH Inclusion Policy and Guidelines are updated to provide additional guidance on reporting analyses of sex differences, race, and ethnicity differences by study intervention effects for all NIH-defined Phase III clinical trials. The valid analyses, or stratified results reporting, should be conducted for each primary outcome measure by sex/gender and by race and/or ethnicity. Annually, applicants/investigators must provide an update on their progress in meeting the NIH-funded objectives, including providing the number of individuals enrolled in research study, broken out by sex/gender, race, and ethnicity. Valid analysis reporting in is required for Applicable NIH-defined Clinical Trials (ACTs).

Learn more at:

Read background information:

Policy link for NIH Guide Notice on Valid Analysis: NOT-OD-18-014

Policy Information

Historical Documents and References