NOT-OD-25-131 announces effective August 18, and applicable to all NIH-supported grants, contracts, and studies moving forward, NIH has revised its Inclusion Policy to align with Executive Order 14168, replacing the term “sex/gender” with “sex” and updating race/ethnicity categories to match federal data standards.
Women and members of racial and/or ethnic minority groups and their subgroups must be included in all NIH-funded clinical research, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center/Office Director that inclusion is inappropriate with respect to the health of the participants[1] or the purpose of the research. Cost is not an acceptable reason for exclusion except when the study duplicates data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. The policy applies to research participants of all ages in all NIH-supported clinical research studies.
The inclusion of women and members of racial and/or ethnic minority groups and their subgroups must be addressed in developing a research design or contract proposal appropriate to the scientific objectives of the study. The research plan/proposal should describe the composition of the proposed study population in terms of sex and race and/or ethnicity groups and provide a rationale for selection of such participants. The plan/proposal should contain a description of the proposed outreach programs for recruiting women and members of racial and/or ethnic minority groups as participants.
The Policy outlines specific elements investigators must consider when planning, conducting, analyzing, and reporting an NIH defined Phase 3 Clinical Trials. Based on prior studies, investigators would consider one of three situations: 1. Prior Studies Support the Existence of Significant Differences 2. Prior Studies Support No Significant Differences 3. Prior Studies Neither Support nor Negate Significant Differences. In submissions to ClinicalTrials.gov, NIH-defined Phase 3 applicable clinical trials must specify outcomes and include results of valid analyses by sex and race and/or ethnic group(s).
Within the Roles and Responsibilities section, the Principal Investigator’s section expands guidance for the research plan/proposal requirements identified above. Additional Roles and Responsibilities outlining additional instructions and definitions are detailed within the Notice.
Please see Notice on where to direct inquiries.