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Inclusion of Women and Minorities as Participants in Research Involving Human Subjects

Learn about the policy for the Inclusion of Women and Minorities in NIH-funded research and how to comply with this policy in applications and progress reports.

On This Page:

Purpose

NIH is mandated by the Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2 Link to Non-U.S. Government Site - Click for Disclaimer  to ensure the inclusion of women and members of racial and ethnic minority groups in all NIH-funded clinical research in a manner that is appropriate to the scientific question under study. The primary goal of this law is to ensure that research findings can be generalizable to the entire population. Additionally, the statute requires clinical trials to be designed to analyze whether study outcomes differ for women and members of racial and ethnic minority groups.

Implementation

Applications & Proposals

All NIH-funded studies that meet the NIH definition for clinical research must address plans for the inclusion of women and minorities within the application or proposal. Using the PHS Human Subjects and Clinical Trial Information Form, applications and proposals should describe the composition of the proposed study population in terms of sex or gender, racial, and ethnic groups, and provide a rationale for the proposed section. Any exclusions based on sex or gender, race, or ethnicity must include a rationale and justification based on a scientific or ethical basis. Investigators should also plan for appropriate outreach programs and activities to recruit and retain the proposed study population consistent with the purposes of the research project. Refer to the PHS Human Subjects and Clinical Trial Information Form Instructions for complete guidance on what to address in your application.

Peer Review

Scientific Review Groups will assess each application/proposal as being "acceptable" or "unacceptable" with regard to the inclusion of racial and ethnic minorities and women in the research project. For additional information on review considerations, refer to the Guidelines for the Review of Inclusion in Clinical Research. For information regarding the coding used to rate inclusion during peer review, see the list of NIH Peer Review Inclusion Codes.

Progress Reports

NIH recipients/offerors must collect and annually report information on sex or gender race, and ethnicity in progress reports. Refer to this Decision Tree for help determining reporting expectations for different types of studies.

Special Considerations for NIH-defined Phase III Clinical Trials

Applications & Proposals: If the proposed research includes an NIH-defined Phase III Clinical Trial, evidence must be reviewed to show whether or not clinically important differences in the intervention effect by sex or gender, race, and/or ethnicity are to be expected. The application or proposal must address plans for the valid analysis of group differences on the basis of sex or gender, race, and ethnicity unless there is clear evidence that such differences are unlikely to be seen.  

Progress Reports: For projects involving NIH-defined Phase III Clinical Trials, annual Research Performance Progress Reports (RPPRs) should include a statement indicating the status of analyses of the primary outcome by sex or gender, race, and ethnicity. The results of these analyses should be included in the “Project Outcomes” section of the RPPR. See the Sample Project Outcomes page for an example. 

Registering & Reporting in ClinicalTrials.gov: NIH-defined Phase III Clinical Trials that also meet the definition of an applicable clinical trial must report the results of the valid analysis of group differences in ClinicalTrials.gov. The valid analyses should be done for each primary outcome measure by sex or gender, and race and/or ethnicity. Upon study registration in ClinicalTrials.gov, outcome measures should be pre-specified by sex or gender, and race and/or ethnicity to prepare for reporting results in this stratified manner. Refer to the Guidance for Valid Analysis Reporting and NOT-OD-18-014 for additional information.

For more information on valid analysis, see the Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical Trials (Valid Analysis) page. 

Policy Notices and Procedures

TitleDescriptionPosted Date
NOT-OD-18-014:  Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical ResearchAmendment to the NIH policy on the inclusion of women and minorities as subjects in clinical research.  Includes requirement that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analyses by sex or gender, race, and/or ethnicity are submitted to ClinicalTrials.gov.November 28, 2017
Full Policy: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research – AmendedUpdated NIH policy on the inclusion of women and minorities as subjects in clinical research, which supersedes the 1994 Federal Register Notice and NOT-OD-OO-048October 9, 2001
NOT-OD-02-001: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical ResearchConsolidated and concise summary of the updated NIH policy on the inclusion of women and minorities in clinical research.October 9, 2001
NOT-OD-01-053: NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical ResearchAdditional guidance and instruction for using the revised minimum standards for maintaining, collecting, and presenting data on race and ethnicity. August 8, 2001

 

Resources

TitleDescriptionPosted Date
Allowable Costs Related to Participant Inclusion Activities in NIH GrantsThis one-page resource highlights allowable costs for NIH grants that can be utilized to enhance inclusion through recruitment and retention activities. Allowable costs listed in the NIH Grants Policy Statement are provided with examples of inclusion-related activities.August 10, 2023
National Academies of Science, Engineering, and Medicine (NASEM) Report: Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups Link to Non-U.S. Government Site - Click for Disclaimer
This NASEM report summarizes a study examining the long-term economic and medical impacts of the underrepresentation of women and racial and ethnic minorities in clinical research and subsequent translational work. The report includes recommendations for NIH and other agencies within the Department of Health and Human Services to increase participation.
 
 
 
 
May 19, 2022
Podcast: Inclusion Plans (Part 1): The Application In Part 1 of this NIH All About Grants podcast miniseries, NIH’s Inclusion Policy Officer Dawn Corbett tells us how to consider inclusion plans when putting together an application.
 
April 20, 2022
Podcast: Inclusion Plans (Part 2): Peer Review and Post-AwardNIH’s Inclusion Policy Officer Dawn Corbett covers inclusion plans during peer review and post-award in Part 2 of this NIH All About Grants podcast miniseries.April 20, 2022
Resource List: Recruitment and RetentionDocument listing resources on recruitment and retention of women, racial and ethnic minorities, and individuals across the lifespan. Resources include toolkits, articles, and more.May 9, 2022
Webpage: Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical TrialsGuidance for understanding the definition of valid analysis and links to key resources for investigators and recipeientsMarch 8, 2022

Video  Link to Non-U.S. Government Site - Click for Disclaimer : Including Diverse Populations in NIH-funded Clinical Research

Video presentation by the NIH Inclusion Policy Officer for the NIH Grants Conference PreCon event, Human Subjects Research: Policies, Clinical Trials, & Inclusion, in December 2022. The presentation explains NIH inclusion policies and requirements for applicants and recipients.January 27, 2023
Open Mike Blog: NIH Inclusion Data by Research and Disease Category Now AvailableAnnouncing the availability of data on sex or gender, race, and ethnicity by NIH Research, Condition, and Disease Classification (RCDC) category.April 11, 2022
ReportInclusion statistics by NIH RCDC categoryReport on the representation of participants in human subjects studies from fiscal years 2018-2021 for FY2018 projects associated with the listed Research, Condition, and Disease Categorization (RCDC) categories. April 11, 2022

Podcast: Reporting the Results of Valid Analyses

The "All About Grants" podcast featuring an interview with the Inclusion Policy Officer about valid analysis reporting for the Inclusion of Women and Minorities policy.August 6, 2018
Human Subjects System (HSS): HSS overview and training informationAs of June 9, 2018, the Human Subjects System (HSS) replaced the Inclusion Management System (IMS). Similar to IMS, HSS is used by NIH staff, grant applicants, and recipients to manage human subjects information, including inclusion information.May 25, 2018
Guidance: Valid Analysis Reporting in ClinicalTrials.gov for Applicable NIH-Defined Phase III Clinical TrialsThis guidance document describes the required ClinicalTrials.gov reporting of valid analysis results for applicable NIH-defined Phase III clinical trials. The guidance includes examples and recommendations for creating the NIH-required outcomes during registration and entering results for reporting.May 21, 2018
Open Mike Blog: Continuing to Strengthen Inclusion Reporting on NIH-funded Phase III TrialsBlog post by NIH's Deputy Director of Extramural Research, Dr. Mike Lauer describing valid analysis and the reporting requirements for applicable NIH-Defined Phase III clinical trials.January 8, 2018
Decision Tree: Applying the Inclusion of Women and Minorities PolicyA tool for understanding how to monitor inclusion based on sex or gender, race and ethnicity in research.January 3, 2018
Comprehensive Reports on Monitoring Adherence: Inclusion of Women and Minorities in Clinical ResearchReports published by the Department of Health and Human Services. The data tables included in these reports provide documentation of the monitoring of inclusion with some degree of analysis.September, 2017


Have additional questions? Contact your program officer or the Inclusion policy team: Inclusion@od.nih.gov