NIH Inclusion Policy

Policy Information

• NIH: Better Oversight Needed to Help Ensure Continued Progress Including Women in Health Research
• Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency (PDF - 1.6 MB)
• NIH Revitalization Act of 1993 (PDF - 109.4KB)
• The NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research, October 2001
• NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research
  This notice provides additional guidance and instruction for using the revised minimum standards for maintaining, collecting, and presenting data on race and ethnicity.
• NIH Policy Implementation Page – Inclusion of Women and Minorities as Participants in Clinical Research
  The site includes information on NIH Institute and Center contacts, NIH forms and applications as well as additional links to inclusion policy compliance.
• Inclusion of Children in Research Policy

Historical Documents and References

• Enrolling Pregnant Women: Issues in Clinical Research (PDF - 2.5MB)
  A summary of a 2010 forum co-sponsored by the ORWH, the Food and Drug Administration Office of Women's Health, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and several NIH Institutes and Offices, that examined persistent under-inclusion of pregnant women in clinical research.
• NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
  Published March 1994 in the Federal Register.