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).

Two distinct policies, commonly discussed together

NIH Policy and Guidelines on the Inclusion of Women and Members of Racial and/or Ethnic Minority Groups in Clinical Research is the older of the two, with a statutory basis in PHS Act section 492B (42 U.S.C. section 289a-2), stemming from the 1993 NIH Revitalization Act. It requires NIH-funded clinical research to include women and members of racial/ethnic minority groups appropriate to the scientific question being asked, unless a clear and compelling scientific or ethical rationale justifies excluding a group. Applications must describe the planned study population by sex/gender and race/ethnicity with supporting rationale, and Phase III clinical trials specifically must include a valid analysis plan for whether the intervention’s effects differ by sex/gender and by race/ethnicity; that sex/gender and race/ethnicity enrollment data is then collected and reported in progress reports. The policy’s most recent revision, NOT-OD-25-131 (posted 17 July 2025), retitled the policy and updated its terminology to align with Executive Order 14168 (referring to sex, not sex/gender) and OMB Statistical Policy Directive No. 15’s race/ethnicity categories.

NIH Policy on the Inclusion of Individuals Across the Lifespan is the newer, age-focused policy: it requires individuals of all ages — including children and older adults — to be included in NIH-funded human subjects research unless a scientific or ethical reason justifies exclusion for a given study. It applies to applications submitted for due dates on or after 25 January 2019, per NOT-OD-18-116. Applications must justify any age-based exclusion, and grant budgets are expected to account for the recruitment and retention costs of enrolling across the full scientifically relevant age range.

What “compelling rationale” means in practice

Neither policy bans excluding a group outright — both require the application to state a specific, study-relevant justification rather than defaulting to a narrow population out of convenience. Acceptable rationales are tied to the scientific question itself (for example, a condition that genuinely occurs, or is genuinely studied, only in one sex, or a safety concern specific to a particular age range); administrative convenience, recruitment difficulty alone, or “that’s how it’s always been done” are not compelling rationales under either policy.

How this interacts with recruitment materials

Because inclusion policy shapes who a study is required to try to enroll, it has a direct practical link to how a study advertises for participants. FDA/OHRP guidance treats direct advertising for research subjects (posters, flyers, digital ad copy) as the start of the informed-consent and subject-selection process, requiring IRB review before use — the same review process that checks the ad is not coercive is also where inclusion-plan consistency (whether the ad’s framing matches the population the application committed to recruiting) typically gets scrutinized.

Worked examples

• 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.
• 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

• 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.
• 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.

Related terms

• Informed consent — the related subject-protection process that recruitment materials and inclusion-plan enrollment both feed into.
• ClinicalTrials.gov — where NIH-funded Phase III trial results, including subgroup analyses required under the inclusion policy, are commonly registered and reported.

Frequently Asked Questions

Does NIH require every study to enroll equal numbers of every group?

No. NIH requires inclusion of women, racial/ethnic minority groups, and the full relevant age range appropriate to the specific scientific question — not a fixed quota or strict demographic parity. A clear, compelling scientific or ethical rationale can justify excluding or limiting a group for a given study.

What is NOT-OD-25-131?

The most recent (17 July 2025) revision to NIH’s Inclusion of Women and Minorities policy notice, which retitled the policy and updated its sex/gender and race/ethnicity terminology to align with Executive Order 14168 and OMB Statistical Policy Directive No. 15.

What is NOT-OD-18-116?

The NIH notice establishing the Inclusion Across the Lifespan policy, applying to applications submitted for due dates on or after 25 January 2019, requiring inclusion of children and older adults in NIH-funded human subjects research absent a scientific/ethical justification for exclusion.

Do these policies apply to all NIH grants, or only clinical trials?

The Inclusion of Women and Minorities policy applies to NIH-defined clinical research broadly, with the Phase III subgroup-analysis requirement specific to Phase III clinical trials. The Inclusion Across the Lifespan policy applies to NIH-funded human subjects research generally, not only trials.

Last verified 2026-08-16 against NIH’s own policy pages (grants.nih.gov/policy-and-compliance/policy-topics/inclusion/women-and-minorities and …/inclusion/lifespan) and notice text (NOT-OD-25-131, NOT-OD-18-116); grants.nih.gov has repeatedly returned access-restricted responses to automated fetches this session, so these citations rely on convergent corroboration across multiple retrieval attempts rather than a single clean fetch — re-verify directly against grants.nih.gov if this page is reused after roughly 6-12 months, since NIH revises inclusion-policy notices periodically.