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Purpose
The 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 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 groups, 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 racial/ethnic 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 |
Report: Inclusion 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