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

Purpose

NIH is mandated by the Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2 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.