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Office of Research on Women's Health (ORWH)

Comprehensive Reports

Inclusion of Women and Minorities in Clinical Research

NIH reports on aggregate inclusion data on study populations for NIH-funded human subjects research since fiscal year 1994. ORWH led efforts to monitor IC adherence to the NIH policy on the inclusion of women and minorities as participants in clinical research, and the policy is well-established in the ICs. The NIH staff continues to monitor and document inclusion and work with grantees and contractors to ensure compliance with the inclusion policy.

When assessing inclusion data, enrollment figures should not be compared directly to the national census figures. The goal of the NIH policy is not to satisfy any quotas for proportional representation based upon census data, but rather to conduct biomedical and behavioral research in such a manner that the scientific knowledge acquired will be generalizable to the entire population of the United States. The number of women, men, and/or representatives of racial/ethnic subpopulations included in a particular study depends upon the scientific question addressed in the study and the prevalence among women, men, and/or racial/ethnic subpopulations of the disease, disorder, or condition under investigation.

Biennial reports (titled 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 listed below. The data tables included in these reports provide documentation of the monitoring of inclusion with some degree of analysis. Caution should be used in interpreting these figures. Conclusions that can be reasonably drawn from the data are provided.



For previous reports before fiscal year 2006, please contact ORWH at or 301-496-9200.

This page last reviewed on December 21, 2015