Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015

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5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical Research

NIH policy requires that women and members of minority groups and their subpopulations be included in all NIH-supported biomedical and behavioral research projects involving NIH-defined clinical research unless a clear and compelling rationale and justification establishes to the satisfaction of the funding IC Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances must be designated 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. 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, race, and ethnicity, and provide a rationale for selection of subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants. See

5.7 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

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, applications for clinical research must include a description of plans for including children and the age range(s). If all children or a subset of children (e.g., children under the age of 18) will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion. Please refer to the NIH Policy on the Inclusion of Children for additional information.

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.

5.8 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research

The Office of Management and Budget (OMB) defines minimum standards for maintaining, collecting and presenting data on race and ethnicity for all Federal reporting agencies (including NIH) in OMB Directive 15: 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. Investigators shall use these categories when collecting and reporting data on race and ethnicity. The collection of greater detail is encouraged, for example on racial or ethnic subpopulations. However, any collection that uses more detail must be designed in a way that data can be aggregated into these minimally required OMB categories. Use self-report or self-identification to collect this information by asking two separate questions – one on ethnicity and one on race. Collect ethnicity information first, followed by the question on race and provide participants with the option to select more than one racial category. When feasible, NIH encourages investigators to include information about individuals who select more than one race and consider that data in their analyses. Participants who self-identify with more than one racial category should be reported to the NIH under the “More than one race” category of the report. See NIH Policy on Inclusion of Women and Minorities and

The following definitions apply to the minimum standards for the ethnic and racial categories.

Ethnic Categories:

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, “Spanish origin,” can be used in addition to “Hispanic or Latino.”

Not Hispanic or Latino

Racial Categories:

American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliation or community attachment.

Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.)

Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”

Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

Ethnic/Racial Subpopulations: In addition to OMB ethnic and racial categories, each ethnic/racial group contains subpopulations that are delimited by geographic origins, national origins, and/or cultural differences. It is recognized that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on self-reporting of specific origins and/or cultural heritage. Attention to subpopulations also applies to individuals who self identify with more than one race. These ethnic/racial combinations may have biomedical, behavioral, and/or socio-cultural implications related to the scientific question under study.
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