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: https://grants.nih.gov/grants/funding/lifespan/lifespan.htm. 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 ClinicalTrials.gov is required for Applicable NIH-defined Clinical Trials (ACTs).

Learn more at: https://grants.nih.gov/grants/funding/women_min/guidelines.htm

Read background information: https://orwh.od.nih.gov/research/clinical-research-trials/nih-inclusion-policy/including-women-and-minorities-clinical

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

Policy Information

• Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency
• NIH: Better Oversight Needed to Help Ensure Continued Progress Including Women in Health Research
• NIH Inclusion Data by Research and Disease Category
• NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research
  • This notice provides additional guidance and instruction for using the revised minimum standards for maintaining, collecting, and presenting data on race and ethnicity.
• NIH Revitalization Act of 1993
• The NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research, October 2001

Historical Documents and References

• Enrolling Pregnant Women: Issues in Clinical Research
  • A summary of a 2010 forum, co-sponsored by the ORWH, the Food and Drug Administration Office of Women's Health, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and several NIH Institutes and Offices, which examined persistent under-inclusion of pregnant women in clinical research.
• NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
  • Published March 1994 in the Federal Register.

References

• Spotlight Blog: Some Thoughts Following the NIH Inclusion Across the Lifespan 2 Workshop
  • Michael Lauer, M.D., NIH Deputy Director for Extramural Research
• NIH Inclusion Across the Lifespan II Workshop
• NIH Inclusion Across the Lifespan Workshop, Day 2
• NIH Inclusion Across the Lifespan Workshop, Day 1
• Inclusion Across the Lifespan 
• Adequacy of Inclusion of Older Adults in NIH‐Funded Phase III Clinical Trials
• AGS Report on Engagement Related to the NIH Inclusion Across the Lifespan Policy
• Disadvantaged, Outnumbered, and Discouraged: Women's Experiences as Healthy Volunteers in U.S. Phase I Trials
• Inclusion of Older Adults in Research: Ensuring Relevance, Feasibility, and Rigor
• The 5Ts: Preliminary Development of a Framework to Support Inclusion of Older Adults in Research