Bill · S. 3564· Senate(119-S-3564)
NIH Clinical Trial Integrity Act
- Introduced
- 12/18/2025
- Last activity
- 12/18/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Andy Kim
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
The NIH Clinical Trial Integrity Act requires NIH-funded research organizations to set clear goals for recruiting and retaining diverse participants based on race, ethnicity, age, and sex. It mandates detailed plans for achieving these goals and encourages the use of less burdensome follow-up methods for participants. The bill also directs a study on removing cost barriers for human subjects and establishes a national public awareness campaign to increase trial diversity. Additionally, it provides grants to nonprofit entities to help with outreach and education efforts.
Yes· 3 of 26
Would Black Americans be better off under this?+9
Directly targets the inclusion of underrepresented racial groups in clinical trials.
Would Hispanic Americans be better off under this?+9
Directly targets the inclusion of underrepresented ethnic groups and provides materials for limited English proficiency.
Would Native Americans be better off under this?+9
Directly targets the inclusion of underrepresented racial groups in clinical trials.
The opposite
Does this protect people from being watched or searched?-1
Requires reporting of aggregate demographic data, though explicitly forbids individually identifiable information.
Does this give people more control over their personal data?-1
Requires annual sharing of aggregate demographic information, which introduces minor privacy risks.
Who it would affect, and how
Potential Positive Impacts for People
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Increased Representation in Research: By requiring goals that reflect the race, ethnicity, age, and sex of patients with a specific condition or the general US population, more diverse groups will be included in medical studies (Section 2(a)(1)).
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Reduced Participant Burden: The bill encourages research organizations to implement easier follow-up options, such as telemedicine, virtual visits, wearable technology, or using local labs and imaging centers (Section 2(a)(4)).
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Improved Accessibility and Awareness: The creation of a national campaign and the distribution of materials in languages for those with limited English proficiency helps more people understand and access clinical trials (Section 4(a) and 4(b)(2)).
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Potential for Financial Support: The bill mandates a study to modernize guidelines for compensating human subjects for their time and reimbursing out-of-pocket expenses (Section 3(2)).
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Community Support: Grants provided to nonprofit organizations, faith communities, and community pharmacies can help these groups better support underrepresented populations in participating in trials (Section 4(d)).
Potential Negative Impacts for People
- Privacy Risks: While the bill mentions privacy protections, it requires the sharing of aggregate demographic information of trial participants on an annual basis (Section 2(b)(1)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For African Americans+9Good For Hispanic Americans+9Good For Native Americans+9Good For Asian Americans+8Good For Low Income Households+7Good For Immigrants+6Good For Men+6Good For Rural Residents+6Good For Women+6Good For Children+5Good For Middle Aged+5Good For People With Disabilities+5Good For Retirees+5Good For Seniors+5Good For Young Adults+5Good For Middle Class Households+4Good For White Americans+4Good For High Income Households+2
- Social Issues And Justice
- Improves Racial Equity+8Improves Gender Equality+6Improves Poverty Reduction+3
- Healthcare
- Improves Healthcare Access+7Increases Research Funding+5
- Governance And Ideology
- Improves Government Transparency+6Increases Federal Power+3Improves Privacy Rights-1
- Education And Technology
- Increases Scientific Research Funding+4Improves Data Privacy-1
- 12/18/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
Susan CollinsRepublican · Maine