To provide written guidelines regarding the federal regulations requiring the inclusion of women and minorities in research studies sponsored by the National Institutes of Health (NIH).
Investigators engaging in NIH-sponsored research will submit the Supplemental Report on the Inclusion of Women and Minorities in Clinical Research as part of the original new study submission and at each continuing review of the study.
Institutions have a responsibility to create an environment in which equitable selection of research participants is fostered. To comply with federal regulations, NIH-supported investigators are required to provide details of the proposed involvement of human subjects in the research, including:
- the characteristics of the subject population,
- anticipated numbers of individuals affected with the condition,
- age ranges of the affected population group,
- health statuses.
The proposed research should specify the gender and racial/ethnic composition of the subject population, as well as criteria for inclusion or exclusion of any subpopulation.
The CHS IRB has an approved template of the Supplemental Report on the Inclusion of Women and Minorities in Clinical Research (see Appendix A). It must be submitted with all new study - and continuing review - submissions, if the study is in some way funded by the NIH. This includes National Cancer Institute (NCI) funded cooperative group oncology trials.
If ethnic, racial, and gender estimates and continuing review numbers are not included in the background data for a protocol, the investigators must provide a clear rational for exclusion of this information (see OHRP guidance at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/hsdc94-01.htm, Section 492B of the Public Health Service Act, and NIH Guide for Grants and Contracts, vol. 23, Number 11, March 18, 1994).
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