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.



• 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.



• 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.



• Inclusion Table (PDF or RTF) - (07/25/2001) - 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 This format is superceded by the Target/Planned Enrollment Table and Inclusion Enrollment Reports that use the 1997 OBM standards for the classification of federal data on race and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) - (PDF or MS Word) - (08/2003) - 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. 5/01) and PHS 2590 (rev. 5/01) instructions and forms.



• Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research (PDF) - (12/2002) - To help investigators to understand and comply with the NIH's inclusion policies, the ORWH collaborated in the preparation and publication of this Notebook. This publication contains two appendices. Appendix A summarizes the inclusion guidelines; Appendix B contains sample questions and answers to assist investigators in preparing their applications in accordance with the inclusion guidelines.

Historical Documents and References: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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