OFFICE FOR PROTECTION OF HUMAN SUBJECTS
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NATIONAL INSTITUES OF HEALTH (NIH) GUIDELINES FOR INCLUSION OF CHILDREN, WOMEN AND MINORITIES IN FUNDED RESEARCH
It is the policy of NIH (National Institutes of Health) that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center 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 Institute/Center 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 the proposed outreach programs for recruiting women and minorities as participants.
PROCEDURES FOR COMPLETING HUMAN SUBJECTS PROTOCOLS THAT ARE FUNDED BY THE NATIONAL INSTITUTES OF HEALTH (NIH)
Protocol applications must provide clear and concise responses that address the issues on the inclusion of children (individuals under the age of 21), women and minorities when responding to questions in parts 4 and 6 of the application (Reseach Overview and Description of Subject Populations). Human subjects research funded by NIH must also include a description of plans for including children. If children will be excluded from the research, the protocol must present an acceptable justification for the exclusion (attachment A, question 7). The policy provides possible reasons for exclusion:
- The research topic is irrelevant to children.
- There are laws barring their inclusion.
- The knowledge being sought is already available for children.
- A separate age-specific study in children is warranted.
- Insufficient data are available to judge the risk of participation to children.
- The study involves follow-up on a previous adult study.
- Other justifications are found acceptable by review groups and the Institute Director.
A complete copy of the NIH Guidelines is available from the Office for Protection of Human Subjects, Riverfront Research Park, Suite 105. Call (541) 346-2510 if you have any questions.
INFORMATION FOR NIH TRAINEES
If any student researcher is a trainee on an Institutional National Research Service Award (NRSA) or training grant, they must conform to the NIH policies on the inclusion of children, women and minorities in study populations. Details of such studies, including a description of the population and the rationale for inclusion/exclusion of children, women and minorities, must be provided to the Office for Protection of Human Subjects and the NIH program administrator of the grant before any trainee undertakes such studies.