Bills · S 3564
IN COMMITTEE· 119TH CONGRESS
Senate BillS 3564Health
NIH Clinical Trial Integrity Act
INTRO DEC 18· LAST ACTION DEC 18
READING
9MIN
COSPONSORS
1
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenThis bill matters because clinical trials, which test the safety and effectiveness of new medicines and treatments, often do not include enough diverse participants. When trials lack diversity, it's harder to know if a treatment will work well for everyone, or if it might have different side effects in different groups of people. For example, some drugs may affect people of different races or ages differently, and if those groups aren't adequately represented in trials, these differences might be missed.
If this bill becomes law, it could lead to better, more inclusive medical research, ensuring that new drugs and therapies are safe and effective for the full spectrum of the American population. This could improve public health outcomes, reduce health disparities, and build greater trust in the medical research process. If it doesn't pass, the current challenges of limited diversity in clinical trials and potential barriers for participants might continue, potentially leading to treatments that are not optimized or fully understood for all patient populations.
KEY PROVISIONS
4AI-extractedPROVISION 01
Requires NIH-funded clinical trial applications to include clear and measurable goals for recruiting and retaining participants based on race, ethnicity, age, and sex, reflecting either the disease prevalence or the general population.
This aims to ensure that clinical trials are designed from the outset to be inclusive and representative, leading to more broadly applicable research findings.
PROVISION 02
Mandates that NIH-funded research organizations share aggregate demographic data of trial participants annually and submit participant retention rates, both disaggregated by race, ethnicity, age, and sex.
This provision provides ongoing oversight and data to track progress in diversity and retention throughout the trial's duration.
PROVISION 03
Requires NIH-funded research organizations to plan for, or explain why they cannot implement, less burdensome follow-up options for trial participants, such as virtual visits, home visits, or using local labs.
This seeks to reduce practical barriers that often prevent people, especially those with limited time or resources, from participating in or completing clinical trials.
PROVISION 04
Directs the Secretary of Health and Human Services to conduct a study on modernizing regulations for reimbursing human subjects for out-of-pocket expenses and compensating them for time, and updating safe harbor rules for incentives.
This aims to identify and address financial barriers that deter participation in clinical trials, potentially making it more feasible for a wider range of individuals to take part.
SPONSORSHIP
1 + 1
D· New Jersey
YRS IN OFFICE
7
BILLS LED
43
COSPONSOR BREAKDOWNBIPARTISAN · 0%
DEM 0 REP 1 IND 0
ACTION TIMELINE
2 EVENTSDEC 18
Introduced in Senate
DEC 18
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
BILL INFO
TypeSenate Bill
NumberS 3564
Congress119th
StatusIn Committee
IntroducedDec 18, 2025
Last actionDec 18, 2025
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IN COMMITTEE· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED DEC 18, 2025
Senate BillS 3564Health
NIH Clinical Trial Integrity Act
INTRODUCED DEC 18, 2025· LAST ACTION DEC 18, 2025
PASSAGE CHANCES
—%
READING
9 min
COSPONSORS
1
COMPLEXITY
Moderate
