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Inclusion Of Women And Minorities In Research Study Populations Involving Human Subjects

·         It is the policy of Federal agencies that women and members of minority groups and their sub-populations must be included in all Federal agency-supported research projects involving human subjects, unless clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public law 103-43).

·         All investigators proposing research involving human subjects should read the “NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research” which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following address: grants.nih.gov/grants/notic-files/not94-100.html. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Inclusion Of Children As Participants In Research Involving Human Subjects

·         It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998.

·         All investigators proposing research involving human subjects should read the “NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects” that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following address: grants.nih.gov/grants/guide/notice-files/not98-024.html.

Last Modified: February 18, 2005