Policy Documents and Reference Materials

• 1993 Revitalization Act (PL-103-43)
• 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.
• Sex/Gender and Minority Inclusion in NIH Clinical Research: What Investigators Need to Know!
  A PowerPoint slide show highlighting the rationale and major components of the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research, as well as the 1997 OMB standards for collecting and presenting data on ethnicity and race.
• What Form Should Private Investigator's Use for Population Tracking? (New versus Old) - (08/2003)
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Historical Documents and References

• NIH Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research - Updated August 2, 2000.
  Changes to the Guidelines, Sections 'III.B. NIH Phase III Clinical Trials' and 'V.
• NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
  A complete text of the Updated Guidelines, with changes to the Guidelines, Sections 'III.B. NIH Phase III Clinical Trials' and 'V.
• NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
  Published: March 1994 in the Federal Register

Comments or Questions
Email: ORWH-research@mail.nih.gov

• Introduction
  
• Background
  
• Comprehensive Reports (1997 - Present)
  
• Outreach Documents
  
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