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 age 18, and older adults, defined as individuals aged 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 the NIH Inclusion Across the Lifespan webpage. This notice applies to all NIH applications submitted on or after January 25, 2019. 

Learn more at “Inclusion Across the Lifespan: Detailed Information and References” below for additional resources. 

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 ClinicalTrials.gov is required for Applicable NIH-defined Clinical Trials (ACTs).

Learn more on the NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research webpage. 

Read background information on the ORWH Including Women and Minorities in Clinical Research Background webpage.  

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

Government Accountability Office (GAO) Report & NIH Response

In October 2015, the Government Accountability Office (GAO) released a report examining women’s participation in NIH research titled Better Oversight Needed to Help Ensure Continued Progress Including Women in Health Research. GAO examined (1) female enrollment and NIH efforts to monitor this enrollment in NIH-funded clinical research and (2) NIH efforts to ensure that NIH-funded clinical trials are designed and conducted to analyze potential sex differences when applicable. GAO recommended that NIH examine and report more detailed data on women’s enrollment in NIH-funded studies and collect, examine, and report data on the extent to which these studies include analyses of potential differences between men and women. NIH agreed with the report and implemented all the GAO recommendations, and all five recommendations were closed by GAO.

Learn more about NIH’s response at Spotlight Blog: Some Thoughts Following the NIH Inclusion Across the Lifespan 2 Workshop (2020)

Read background information at Better Oversight Needed to Help Ensure Continued Progress Including Women in Health Research (2015)

Historical Documents and References

Mandated Policies

• NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research (2001)
• The NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research, October 2001
• NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (1994)
• NIH Revitalization Act of 1993

Inclusion Across the Lifespan: Detailed Information & References

• NIH Inclusion Across the Lifespan II Workshop Videocast (2020)
• Adequacy of Inclusion of Older Adults in NIH‐Funded Phase III Clinical Trials (2019)
• AGS Report on Engagement Related to the NIH Inclusion Across the Lifespan Policy (2019)
• Inclusion of Older Adults in Research: Ensuring Relevance, Feasibility, and Rigor (2019)
• The 5Ts: Preliminary Development of a Framework to Support Inclusion of Older Adults in Research (2019) 
• NIH Inclusion Data by Research and Disease Category (2019)
• Inclusion Across the Lifespan (2018)
• NIH Inclusion Across the Lifespan Workshop, Day 1 Videocast (2017)
• NIH Inclusion Across the Lifespan Workshop, Day 2 Videocast (2017)