NIH Inclusion Policies for Research Subjects

NIH Inclusion Policies (Women, Minorities, and Across the Lifespan)

A study satisfies NIH inclusion requirements when its application describes the planned participant population by sex/gender, race/ethnicity, and age range appropriate to the science; provides a compelling rationale for any exclusion of women, a minority group, or an age range rather than defaulting to exclusion; and, for Phase III trials, includes a valid analysis plan for whether effects differ by sex/gender and race/ethnicity. This combines two distinct NIH policies: the statutory Inclusion of Women and Minorities policy (sex/gender and race/ethnicity, in force since the 1993 NIH Revitalization Act) and the Inclusion Across the Lifespan policy (age, including children and older adults, in force since January 25, 2019 under NOT-OD-18-116).

ByCASRAI Editorial Board

· Last updated 3 Aug 2026

Ask about NIH Inclusion Policies (Women, Minorities, and Across the Lifespan)

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Examples

Worked examples

Is an instance
A Phase III cardiovascular drug trial enrolls a study population reflecting the disease's sex/gender and race/ethnicity distribution and pre-specifies a subgroup analysis of whether treatment effect differs by sex/gender and race/ethnicity.
Is an instance
A chronic-disease study originally limited to adults 18-64 is amended to include children and older adults, or provides NIH a specific scientific/safety rationale for excluding those age ranges, satisfying the Lifespan policy.

Counter-examples

Looks similar, but isn't

Not an instance
An R01 application for a condition affecting both sexes proposes a study population that is about 90% one sex with no stated rationale for the imbalance.
Not an instance
A protocol caps enrollment at age 65 by default convention with no age-specific scientific or safety justification -- the exact practice NOT-OD-18-116 was created to eliminate.

Machine-readable encodings

Use in your systems

JATS XML <role> element

xml

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Schema.org DefinedTerm (JSON-LD)

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