Clinical Research & Human Studies
2.1.3 NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
NIH policy requires that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving clinical research unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant IC Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an IC Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research. This policy applies to research subjects of all ages.
The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. The Research Plan should describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of
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the proposed outreach programs for recruiting women and minorities as participants. See http://grants.nih.gov/grants/funding/women_min/women_min.htm.
2.1.4 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research
See NIH Policy on Reporting Ethnicity/Race and Sex/Gender in Clinical Research in Part II, 5.8.
The Office of Management and Budget (OMB) defines minimum standards for maintaining, collecting, and presenting data on race and ethnicity for all grant, contract, and intramural proposals and for all active research grants, cooperative agreements, contracts, and intramural projects. The minimum standards are described in the 1997 OMB Directive 15, http://www.whitehouse.gov/omb/fedreg/ombdir15.html.
The standards were revised in 1997 and include two ethnic categories (Hispanic or Latino, and Not Hispanic or Latino) and five racial categories (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White). The categories in this classification are social-political constructs and should not be interpreted as being anthropological in nature. NIH is required to use these definitions to allow comparisons to other Federal databases, especially the census and national health databases. Federal agencies will not present data on detailed categories if doing so would compromise data quality or confidentiality standards.
Collection of this information and use of these categories is required for research that meets the NIH definition of clinical research. See Part II, 5.8 for additional information.
2.1.5 NIH Policy on Inclusion of Children
Research involving children (see definition of "child") must comply with the NIH Policy and Guidelines on the Inclusion of Children in Clinical Research. Investigators should obtain full copies of the Policy and Guidelines from NIH staff, or from http://grants.nih.gov/grants/funding/children/children.htm.
NIH policy requires that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH unless there are clear and compelling reasons not to include them. Therefore, proposals for clinical research must include a description of plans for including children. If children will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.
The involvement of children as subjects in research must be in compliance with all applicable subparts of 45 CFR Part 46 as well as with other pertinent Federal laws and regulations.
IRBs have special review requirements to protect the well-being of children who participate in research. These requirements relate to risk, benefit, parental/guardian consent, and assent by children, and to research involving children who are wards of the state or of another institution. The local IRB approves research that satisfies the conditions set forth in the regulations.
DEFINITION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED INDIVIDUALS:
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Socially and Economically Disadvantaged Individual. A member of any of the following groups: Black Americans; Hispanic Americans; Native Americans; Asian-Pacific Americans; Subcontinent Asian Americans; other groups designated from time to time by the Small Business Administration (SBA) to be socially disadvantaged; or any other individual found to be socially and economically disadvantaged by SBA pursuant to Section 8(a) of the Small Business Act, 15 U.S.C. 637(a).
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