S. 3564 — NIH Clinical Trial Integrity Act

This section directs the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to require NIH-funded research organizations or entities seeking funding or approval for clinical trials investigating drugs or devices (as defined in 21 U.S.C. 321), biological products (as defined in 42 U.S.C. 262(i)), or NIH-approved behavioral interventions to submit applications or renewals that include (1) clear and measurable goals for recruitment and retention reflecting the race, ethnicity, age, and sex of patients with the disease or condition (or the U.S. general population if prevalence is unknown); (2) a rationale specifying participant numbers or enrollment/retention strategies by those categories; (3) a detailed plan for achieving the goals, including separate analyses by category and recruitment sufficient for statistically meaningful safety and effectiveness determinations; and (4) a plan for, or explanation against, less burdensome follow-up options (e.g., phone/virtual visits, wearables, or primary care provider involvement). As a condition of NIH funding, such organizations must (1) share annual aggregate demographic data on underrepresented populations during recruitment; (2) report retention rates disaggregated by race, ethnicity, age, and sex annually or as required; (3) complete diversity training; and (4) submit final disaggregated participant counts, all without disclosing individually identifiable or protected health information. This section allows applicants to justify, in lieu of diversity goals, why recruitment of specified population groups is scientifically unjustified or impossible.

This section directs the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to conduct and complete, not later than two years after enactment, a study on (1) the need to review human subject protection regulations specified in 45 C.F.R. part 46 (or successor regulations) and related guidance; (2) modernizing such regulations and guidance to establish updated guidelines for reimbursement of human subjects' out-of-pocket expenses, compensation for time spent participating in clinical trials, and incentives for recruitment of human subjects; and (3) the need for updated safe harbor rules under 42 C.F.R. § 1001.952 (or successor regulations) and § 1128B of the Social Security Act (42 U.S.C. § 1320a-7b) (i.e., Federal Anti-Kickback Statute) with respect to assistance provided under this section.

This section directs the Secretary of Health and Human Services (HHS), in consultation with specified stakeholders (i.e., representatives from FDA, HRSA, HHS Office of Minority Health, CDC, NIH, and community-based resources and advocates), to carry out a national public awareness and education campaign to increase knowledge of the need for diverse clinical trials (i.e., reflecting demographic groups identified in section 2(a)(1)) among individuals including health care professionals, patients, and others. The campaign must include development and distribution of educational materials and public service announcements encouraging participation in clinical trials by members of specified demographic groups; curricula for health care professionals on participating as investigators and enrolling patients; efforts for limited English proficiency access; and best practices and training for recruiting underrepresented populations shared among sponsors, providers, community organizations, and the public. The campaign must also recognize and address health disparities and barriers to clinical trial access and participation for such groups. This section further directs HHS to award grants to nonprofit private entities (e.g., community-based organizations, faith communities, institutions of higher education eligible under section 371 of the Higher Education Act of 1965 [20 U.S.C. 1067q, i.e., certain minority-serving institutions], national organizations serving underrepresented populations, and community pharmacies) to test outreach strategies for diverse clinical trials and cover related administrative costs. This section authorizes $10 million for each of FY2026 through 2029.

This section defines the term "clinical trial" for purposes of the Act as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.