What is the NIH policy on the inclusion of women and minorities as subjects in research?
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. This policy applies to research subjects of all ages in all NIH-funded clinical research studies. NIH-defined Phase III clinical trials (see Definitions) must be designed and carried out to allow for valid analysis of differences between men and women and racial/ethnic groups and this must be communicated to applicants. Peer review groups will determine whether each NIH-defined Phase III clinical trial has an appropriate s
Related Questions
- How does the inclusion policy for women and minorities in clinical research studies apply to the review of research contract proposals and projects?
- Does the policy on the inclusion of women and minorities apply to foreign projects and contract proposals funded by the NIH?
- How will conformance to the policy for inclusion of women and minorities in clinical research affect funding of contracts?
