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119-s-3564119th CongressWALLET

NIH Clinical Trial Integrity Act

Sponsored By: Senator Kim, Andy [D-NJ]

Introduced

Summary

Boosting diversity in NIH-funded clinical trials. This bill would require researchers seeking NIH trial funding to set measurable recruitment and retention goals by race, ethnicity, age, and sex and would tackle cost and awareness barriers to participation.

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  • Families and participants: Would see trial plans that reduce time and travel burdens, including telemedicine, home visits, evening or weekend hours, and use of local labs or wearable tech to ease follow-up.
  • Researchers and NIH-funded sites: Would have to include clear, measurable recruitment and retention goals, justify sample sizes for meaningful subgroup results, complete diversity training, and submit annual demographic and retention reports disaggregated by race, ethnicity, age, and sex.
  • Community groups and health professionals: Would benefit from a national public awareness campaign with materials, PSAs, curricula, and grants to nonprofit and community organizations to test outreach and cover administrative costs. The bill would authorize $10.0 million per year for FY2026–FY2029 for this work.
  • Federal regulatory review: Would require a study within two years on updating human-subject rules for reimbursements, compensation, recruitment incentives, and possible safe-harbor changes under anti-kickback law.

*Authorizes $10.0 million per year for FY2026–FY2029 for the public awareness and grant program.*

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Bill Overview

Analyzed Economic Effects

4 provisions identified: 4 benefits, 0 costs, 0 mixed.

New diversity rules for NIH trials

This bill would require NIH-funded clinical trial applicants to set clear, measurable recruitment and retention goals by race, ethnicity, age, and sex. It would require a written rationale for how many people are needed from each group and a plan to analyze groups separately and enroll enough people to assess safety and effectiveness. Applicants would also need a plan to use less burdensome follow-up options (for example, fewer visits, phone or home visits, telemedicine, or alternate labs) or explain why those options cannot be used. These rules would apply starting on the date of enactment to NIH-funded drug, device, biological, and NIH-approved behavioral intervention trials, but applicants could justify why recruiting a given group is not scientifically necessary.

Reporting and training for NIH trials

This bill would require groups running NIH-funded trials to share aggregated participant demographics each year while recruiting. They would also submit yearly retention rates and final participant counts disaggregated by race, ethnicity, age, and sex. Trial researchers would need to complete education and training on diversity in clinical trials. Any shared data would have to exclude individually identifiable information and follow federal privacy laws and NIH policy.

Education campaign and community grants

This bill would fund a national public awareness campaign to boost knowledge about the need for diverse clinical trial participation. NIH would produce written materials, public service ads, curricula for health professionals, and steps to reach people with limited English. The bill would create grants to nonprofits, community groups, faith communities, colleges, organizations serving underrepresented populations, and community pharmacies to test outreach and cover administrative costs. It would authorize $10,000,000 each year for fiscal years 2026 through 2029 to carry out this work.

Study on payments and safe harbors

Not later than two years after enactment, this bill would require HHS, through NIH, to study whether to update human subject rules and guidance. The study would look at reimbursement for out-of-pocket expenses, compensation for time, and incentives for recruitment. It would also examine whether safe-harbor rules under the Federal Anti‑Kickback Statute and related rules need updating. The study would inform whether regulatory changes are needed to lower cost barriers for people who join clinical trials.

Sponsors & CoSponsors

Sponsor

Kim, Andy [D-NJ]

NJ • D

Cosponsors

  • Sen. Collins, Susan M. [R-ME]

    ME • R

    Sponsored 12/18/2025

Roll Call Votes

No roll call votes available for this bill.

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