NIH Clinical Trial Integrity Act

Bill Number

S. 3564

Origin Chamber

Senate

Congress

119th Congress, Session 1

Status

Introduced

Latest Action

2025-12-18: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Last Updated

2026-01-21T05:23:16Z

AI-Generated Summary

Purpose

The NIH Clinical Trial Integrity Act (S. 3564) aims to enhance diversity in clinical trials funded by the National Institutes of Health (NIH) by requiring measurable recruitment and retention goals for underrepresented groups, reducing participation barriers, and launching public education efforts. This ensures that trials better reflect the U.S. population, leading to more equitable and effective medical research outcomes for drugs, devices, biological products, or behavioral interventions.

Key Provisions

• Diversity Requirements for Funding Applications (Sec. 2):
• NIH-funded research organizations must include in funding applications or renewals:
• Clear, measurable goals for recruiting and retaining participants based on race, ethnicity, age, and sex, reflecting either the affected patient population or the general U.S. population if disease prevalence is unknown.
• A rationale explaining how participant numbers will be determined or strategies for enrollment across groups.
• A detailed plan for achieving goals, including separate analysis of subgroups and recruitment methods that ensure scientific validity and sufficient sample sizes for meaningful safety and effectiveness data.
• Plans to implement less burdensome follow-up options (e.g., phone/virtual visits, wearable tech, or flexible scheduling) or explanations why they cannot.
• As a funding condition:
• Annual sharing of aggregate demographic data (without personal identifiers) on underrepresented groups during the trial.
• Annual reporting of retention rates by demographic category.
• Mandatory training for researchers on clinical trial diversity.
• Final submission of participant numbers by demographics at trial end.
• Exceptions allowed if recruitment of certain groups is not scientifically justified or feasible, with supporting reasoning.
• All data sharing must comply with federal privacy laws (e.g., no individually identifiable health information).

• Study on Cost Barriers (Sec. 3):
• Within two years of enactment, the NIH Director must complete a study reviewing and modernizing human subject regulations (e.g., on reimbursing out-of-pocket costs, compensating time spent, and recruitment incentives).
• The study will also assess updates to "safe harbor" rules under anti-kickback laws to allow such assistance without legal risks.

• Public Awareness and Education Campaign (Sec. 4):
• A national campaign, in consultation with HHS agencies (e.g., FDA, CDC) and community advocates, to raise awareness among the public, patients, and healthcare professionals about the importance of diverse clinical trials.
• Campaign elements include:
• Educational materials, public service announcements targeting underrepresented groups, and curricula for professionals on trial participation and patient enrollment.
• Efforts for limited English proficiency access and addressing health disparities/barriers (e.g., access to care).
• Best practices sharing for recruitment among sponsors, providers, and community organizations.
• Grants to nonprofits (e.g., community groups, faith-based organizations, universities, pharmacies) for outreach strategies and administrative support to diversify trials.
• Authorizes $10 million annually for fiscal years 2026–2029.

• Definition (Sec. 5):
• "Clinical trial" is defined as a study assigning human participants to interventions (including controls or placebos) to evaluate effects on health-related biomedical or behavioral outcomes.

Significant Changes to Existing Law

• Introduces mandatory diversity goals and reporting in NIH funding applications, which were previously encouraged but not required—shifting from voluntary guidelines to enforceable conditions.
• Mandates a study to update federal regulations on participant compensation and incentives, potentially expanding "safe harbors" under anti-kickback statutes (which prohibit improper financial inducements in healthcare) to explicitly allow trial-related reimbursements.
• Establishes a new national campaign and grant program, formalizing federal efforts to address trial underrepresentation, building on existing but less structured initiatives like those from the NIH's inclusion policies.

Potential Impacts

• Government Agencies: NIH and HHS will face increased administrative burdens for reviewing applications, monitoring reports, conducting the cost study, and managing the campaign/grants; could lead to more efficient resource allocation in research funding toward equitable trials.
• Citizens: Underrepresented groups (by race, ethnicity, age, sex) may gain better access to trials, reducing health disparities and improving treatment applicability; participants could benefit from reduced burdens via flexible follow-ups and potential reimbursements.
• International Relations: Minimal direct impact, though enhanced U.S. trial diversity could indirectly strengthen global health research standards by setting a model for inclusive methodologies.

Main Stakeholders Affected

• NIH and HHS Agencies: Primary implementers, including the NIH Director, FDA, CDC, and Office on Minority Health, responsible for oversight, studies, and campaign execution.
• Researchers and Institutions: NIH-funded organizations must adapt protocols, reporting, and training, potentially increasing costs but improving research quality.
• Clinical Trial Participants: Especially underrepresented populations, who gain targeted recruitment, education, and barrier reductions.
• Healthcare Professionals: Providers and investigators receive training and tools to boost enrollment from diverse groups.
• Nonprofits and Communities: Community-based organizations, faith groups, and advocates eligible for grants to support outreach, enhancing their role in health equity.
• Pharmaceutical and Device Sponsors: Indirectly affected through NIH-funded trials, facing pressure for more inclusive designs.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens compliance with existing laws like the Federal Food, Drug, and Cosmetic Act and Public Health Service Act by embedding diversity in funding; the privacy protections align with HIPAA (Health Insurance Portability and Accountability Act), ensuring no new data exposure risks. The anti-kickback study could clarify ambiguities in compensation rules, reducing litigation potential for trials.
• Constitutional: No apparent conflicts; promotes equal protection under the law by addressing disparities without infringing on free speech or due process—focuses on voluntary participation and scientific justification for exceptions.
• Political: Advances health equity agendas, potentially bridging bipartisan support (introduced by Sens. Kim and Collins); could influence future funding debates by tying grants to diversity metrics, emphasizing social justice in biomedical research without mandating quotas.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Kim, Andy [D-NJ]

Cosponsors (1)

Sen. Collins, Susan M. [R-ME]

Recent Actions

• 2025-12-18: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• 2025-12-18: Introduced in Senate

Bill Versions

• NIH Clinical Trial Integrity Act — issued 2025-12-18 — PDF (11 pages)