AMENDMENT: NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH - OCTOBER, 2001 Release Date: October 9, 2001 (11/06/06 - See updated list of NIH contacts (MS Word) for this policy) NOTICE: NOT-OD-02-001
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National Institutes of Health The National Institutes of Health policy on the Inclusion of Women and Minorities as Subjects in Clinical Research has been amended. A complete copy of the amended policy may be found on the "Inclusion of Women and Minorities Policy Implementation" web site: The October 2001 policy provides a consolidated, concise, and clear document of the updates and changes to the NIH policies to implement the original legislation (PL 103-43), the 1994 Federal Register notice ( and the August 2000 notice in the NIH Guide to Grants and Contracts ( EFFECTIVE DATE: This amended policy is effective immediately and applies to all grants and cooperative agreements currently active and to be awarded. Contract solicitations issued as of October 2001 must adhere to the amended policy. The amended policy incorporates the following four points: 1. The definition of clinical research as reported in the "1997 Report of the NIH Director’s Panel on Clinical Research" is used to implement the NIH policy on the inclusion of women and minorities as subjects in clinical research. In June 2001, NIH adopted the definition of clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies, (2) Epidemiologic and behavioral studies, and (3) Outcomes research and health services research 2. Racial and ethnic categories have been updated in order to comply with the new standards issued by the Office of Management and Budget (OMB) in Directive No. 15 This directive defines the minimum standards for maintaining, collecting, and presenting data on race and ethnicity for all Federal reporting. NIH is required to use these definitions to allow comparisons to other federal databases, especially the census and national health databases. The categories in this classification are social-political constructs and should not be interpreted as anthropological in nature. 3. Language governing NIH-defined Phase III clinical trials has been clarified in order to be consistent with the mandate for the inclusion of women and minorities as subjects in clinical research (PL103-43), the new PHS 398 form and OMB Directive 15. The amended policy provides additional guidance on the analyses and reporting of analyses of sex/gender, racial/ethnic and relevant subpopulation differences in intervention effects for NIH-defined Phase III clinical trials. 4. Roles and responsibilities of NIH staff and the extramural community have been updated with regard to the implementation of the NIH policy on the inclusion of women and minorities as subjects in clinical research. While this policy applies to all applicants/offerors for NIH-fundeded clinical research, certain individuals and groups have special roles and responsibilities with regard to its implementation.

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