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

Learn about the policy for 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

The 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 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 provide information about differences by sex/gender, race and/or ethnicity.


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/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Any exclusions based on sex/gender or race/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 minorities and both genders in the research project. For additional information on review considerations, refer to the Guidelines for the Review of Inclusion in Clinical Research.
 

Progress Reports

NIH recipients/offerors must collect and annually report information on sex/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 sex/gender and race/ethnicity differences in the intervention effect are to be expected. The application or proposal must address plans for the valid analysis of group differences on the basis of sex/gender, race, and ethnicity unless there is clear evidence that such differences are unlikely to be seen.

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/gender, and race and/or ethnicity. Upon study registration in ClinicalTrials.gov, outcome measures should be pre-specified by sex/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.


Policy Notices and Procedures

Title

Description

Posted Date

NOT-OD-18-014:  Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research

Amendment 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/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 – Amended

Updated 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-048

October 9, 2001

NOT-OD-02-001: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research

Consolidated 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 Research

Additional guidance and instruction for using the revised minimum standards for maintaining, collecting, and presenting data on race and ethnicity 

August 8, 2001

 

Resources

Title

Description

Posted Date

Open Mike Blog: NIH Inclusion Data by Research and Disease Category Now Available Announcing the availability of data on sex/gender and race/ethnicity by NIH Research, Condition, and Disease Classification (RCDC) category. May 6, 2019
ReportInclusion statistics by NIH RCDC category Report on the representation of participants in human subjects studies for FY2018 projects associated with the listed Research, Condition, and Disease Categorization (RCDC) categories.  May 6, 2019

Human Subjects System (HSS): HSS overview and training information

As 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 Trials

This 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

Decision Tree: Applying the Inclusion of Women and Minorities Policy

A tool for understanding how to monitor inclusion based on sex/gender, race and ethnicity in research.

January 3, 2018

Comprehensive Reports on Monitoring Adherence: Inclusion of Women and Minorities in Clinical Research

Biennial reports 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