Inclusion of Women and Minorities as Participants in Research Involving Human Subjects: Training, FAQs and Other Resources


Training Tools

Title Description Link Original Posting Date
Guidance: Valid Analysis Reporting in for Applicable NIH-Defined Phase III Clinical Trials This guidance document describes the required 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. PDF 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. PDF


January 3, 2018

Podcast on Including Women, Children, and Minorities in Clinical Research

Audio podcast showcasing the requirements for including women, minorities and children in clinical research.



April 6, 2011


FAQ Title Description Link Original Posting Date
FAQ: Inclusion Based on Sex/Gender and Race/Ethnicity Frequently asked questions about the NIH Inclusion policy, including information regarding the submission of NIH Applications/Proposals, the collection and reporting of sex/gender and race/ethnicity data, the peer review process and funding decisions, and monitoring inclusion when working with existing datasets, research participants outside of the United States, and multi-site studies. Website January 10, 2018

Other Resources

Title Description Link Original Posting Date
Human Subjects System (HSS): Overview information As of June 9, 2018, the Human Subjects System (HSS) replaced the Inclusion Management System (IMS). Similar to IMS, HSS will be used by NIH staff, grant applicants, and recipients to manage human subjects information, including inclusion information.  Website
May 25, 2018
Training information: Human Subjects System (HSS) HSS How-to videos for PIs, NIH staff, and other users. Website May 25, 2018

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

Biennial reports, Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research; Comprehensive Report: Tracking of Clinical Research, published by the Department of Health and Human Services are shown. The data tables included in these reports provide documentation of the monitoring of inclusion with some degree of analysis. Website

January 14, 2014

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