Current Policy Documents and References:

• Sex/Gender and Minority Inclusion in NIH Clinical Research: What Investigators Need to Know! (11/21/2002) - 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.



• NIH Forms and Applications - Application Instructions, forms and enrollment tables formats for addressing the Inclusion Policy in the PHS 398, SF424 (R&R), etc. The instructions are contained within the Human Subjects Section of the Research Plan.



• Annual Comprehensive Reports on Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research - Reports beginning with Fiscal Year 1997 data from the ORWH Inclusion of Women in Clinical Research Page.
  Summary Report of NIH Inclusion Data - FY2005 (PowerPoint - 1.11 MB) - Presentation to Advisory Committee on Research on Women's Health, October 24, 2006.



• 10/09/2001 NIH Guide Notice - The NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research was amended October 2001. Click here for a complete copy of the Amended Policy that provides full explanation of the October 2001 policy notice.
  NIH contacts (11/06/06) - (MS Word - 61 KB) - See updated list of NIH contacts for this policy.



• Inclusion Table - (07/25/2001) - (PDF - 32 KB) or (RTF - 35 KB) - Prior format for reporting sex/gender and race/ethnicity data using the 1977 OMB standards for the classification of federal data on race and ethnicity. This format is superceded by the Target/Planned Enrollment Table (PDF - 329 KB) and Inclusion Enrollment Reports (PDF - 604 KB) that use the 1997 OBM standards for the classification of federal data on race and ethnicity.



• What Form Should PIs Use for Population Tracking? (New versus OLD) - (08/2003) - (PDF - 152 KB) or (MS Word - 183 KB) - Information on when to use 05/01 Population Tracking form versus the previous 04/98 version.



• 08/08/2001 NIH Guide Notice - 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 found in the PHS 398 (rev. 9/04) and PHS 2590 (rev. 9/04) instructions and forms.
  NIH contacts (11/06/06) - (MS Word - 61 KB) - See updated list of NIH contacts for this policy.
  NOTE: A web-based FAQ on Reporting Race and Ethnicity Data is available.



• Outreach Notebook and Outreach Frequently Asked Questions - are available to help investigators to understand and comply with the NIH's inclusion policies. ORWH collaborated in the preparation and publication of these documents in December, 2002.
  NOTE: A web-based Outreach Notebook FAQs version concerning the NIH Guidelines is now available for easy access to individual questions.



• The Science of Sex and Gender in Human Health Online Course Web Site - This site was developed by NIH and FDA for researchers, clinicians, and members of academia to gain a basic scientific understanding of the major physiological differences between the sexes, the influences these differences have on illness and health outcomes, and the implications for policy, medical research, and health care. Continuing medical education credit is available for physicians

Historical Documents and References:

• 08/02/2000 NIH Guide Notice - 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. Definitions' are highlighted in bold type.



• NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research - Updated August 2, 2000 - A complete text of the Updated Guidelines, with changes to the Guidelines, Sections 'III.B. NIH Phase III Clinical Trials' and 'V. Definitions' highlighted in bold type. The list of NIH Contacts has also been updated.



• 03/18/1994 NIH Guide Notice - NIH Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research.

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