# 119-s-3564: NIH Clinical Trial Integrity Act

119-s-3564, NIH Clinical Trial Integrity Act, is a 119th Congress bill sponsored by Sen. Kim, Andy [D-NJ] (D-NJ); status introduced; PRIA reads it as touching household money (as of 2026-04-21).

- Canonical: https://policyrisk.com/legislation/119-s-3564
- As of: 2026-04-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-3564
- Congress: 119
- Title: NIH Clinical Trial Integrity Act
- Status: introduced
- Introduced: 2025-12-18
- Sponsor: Sen. Kim, Andy [D-NJ] (D-NJ)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-04-21

## 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. - 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.*

## Cosponsors (1)

- Sen. Collins, Susan M. [R-ME] (R-ME), 2025-12-18T00:00:00.000Z

## Provisions PRIA read

- New diversity rules for NIH trials: benefit, medium. 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 peopl…
- Reporting and training for NIH trials: benefit, medium. 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 educa…
- Education campaign and community grants: benefit, low. 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 gr…
- Study on payments and safe harbors: benefit, low. 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 saf…

## Related bills

- 119-s-2120: Older Americans Act Reauthorization Act of 2025
- 119-s-1541: SHIPS for America Act of 2025
- 119-s-5022: Cannabis Administration and Opportunity Act
- 119-s-2838: Protecting Our Democracy Act
- 119-s-2819: Head Start for America's Children Act
- 119-s-1748: Kids Online Safety Act

## Sources
- [119-s-3564 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/3564)

## Related
- [119-s-2120: Older Americans Act Reauthorization Act of 2025](https://policyrisk.com/legislation/119-s-2120)
- [119-s-1541: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-s-1541)
- [119-s-5022: Cannabis Administration and Opportunity Act](https://policyrisk.com/legislation/119-s-5022)
- [119-s-2838: Protecting Our Democracy Act](https://policyrisk.com/legislation/119-s-2838)
- [119-s-2819: Head Start for America's Children Act](https://policyrisk.com/legislation/119-s-2819)
- [119-s-1748: Kids Online Safety Act](https://policyrisk.com/legislation/119-s-1748)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-3564 (as of 2026-04-21).