Office of Research on Women's Health (ORWH)
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.
REPORT: FISCAL YEARS 2013 & 2014
- For an overview of activities and programs, see the Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research section (page 37) of the ORWH Report.
- For aggregate data tables, see Appendix E: Aggregate Enrollment Data Tables and Trend Data.
- View the full FY2013-2014 Report of the NIH Advisory Committee on Research on Women’s Health.
- Fiscal Years 2011 & 2012
- Fiscal Years 2009 & 2010
- Fiscal Years 2008 & 2009
- Fiscal Years 2007 & 2008
- Fiscal Years 2006 & 2007
For previous reports before fiscal year 2006, please contact ORWH at firstname.lastname@example.org or 301-496-9200.