What are the requirements for including women and minority subjects in NIH-funded studies?
NIH policy requires the inclusion of women and members of minority groups and their subpopulations 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 or 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 or center director based on a compelling rationale and justification. This policy applies to research subjects of all ages. 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. NIH fund
