NIH Clinical Trial Integrity Act
- Bill Number
- H.R. 6867
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-12-18: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-01-22T14:55:44Z
AI-Generated Summary
Purpose This legislation directs the Secretary of Health and Human Services, through the Director of the National Institutes of Health (NIH), to increase diversity in clinical trials for drugs, devices, biological products, and behavioral interventions. It aims to ensure trial participants better reflect the race, ethnicity, age, and sex of patients with the condition under study or the broader U.S. population.
Key Provisions
- Diversity Goals (Section 2): Sponsors must submit applications including measurable recruitment and retention goals based on demographic data, rationales for those goals, detailed plans for achievement (such as separate analysis of groups, community partner involvement, and proportional representation), less burdensome follow-up options, and training on diversity and health inequities.
- Reporting and Terms: Sponsors agree to annual sharing of aggregate demographic data, retention rates by group, completion of diversity training by researchers and reviewers, and final participant counts by demographics, with privacy protections.
- Exceptions and Publication: Sponsors may explain why certain groups are unnecessary; NIH must publish summaries of goals or exceptions on a public website without revealing study design.
- Remediation: If goals are missed, sponsors must create and implement a strategic plan with advocacy groups within set timelines; technical assistance may be provided.
- Waivers and Studies: Ongoing NIH-funded trials are exempt; the Government Accountability Office must study federal efforts to address participation barriers.
- Nondiscrimination: Section 1557 of the Affordable Care Act applies to covered trials.
- Cost Barriers (Section 3): NIH must complete a study within two years on updating human subject regulations for reimbursements, compensation, incentives, and anti-kickback safe harbors.
- Public Awareness (Section 4): NIH and FDA must run a national campaign with educational materials, public service announcements, curricula for professionals, focus groups, and grants to nonprofits for outreach, with $10 million authorized annually from 2027 to 2030.
Significant Changes to Existing Law The bill adds new mandatory diversity planning, annual reporting, and remediation requirements for NIH-approved clinical trials, which were not previously required in this structured form. It expands NIH oversight to include publication of trial summaries, community involvement mandates, and training obligations. It also initiates regulatory reviews for cost-related barriers and launches a funded public education program.
Potential Impacts
- Government Agencies: Increases NIH administrative workload for application reviews, website management, remediation oversight, and grant programs; requires coordination with FDA and other HHS offices.
- Citizens: May improve representation of underrepresented groups in trials, potentially leading to more equitable health data and treatments; addresses access barriers through education and reduced participation costs.
- International Relations: No direct provisions affect international relations.
Main Stakeholders Affected
- Clinical trial sponsors (e.g., researchers and companies seeking NIH protocol approval).
- NIH, FDA, and other HHS agencies (e.g., Office on Minority Health, CDC).
- Patients and communities from underrepresented racial, ethnic, age, and sex groups.
- Community-based organizations, advocacy groups, healthcare professionals, and institutions of higher education eligible for grants.
- Congress (via required reports).
Notable Legal, Constitutional, or Political Implications The bill incorporates existing nondiscrimination rules from the Affordable Care Act and references Federal privacy laws for data handling. It may raise questions about balancing scientific justification with demographic goals in trial design. No explicit constitutional issues are addressed in the text.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (11)
Rep. Fitzpatrick, Brian K. [R-PA-1], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Tonko, Paul [D-NY-20], Rep. Stansbury, Melanie A. [D-NM-1], Rep. Casten, Sean [D-IL-6], Rep. McClellan, Jennifer L. [D-VA-4], Rep. Moore, Gwen [D-WI-4], Rep. Pocan, Mark [D-WI-2], Rep. Gottheimer, Josh [D-NJ-5], Rep. Jayapal, Pramila [D-WA-7], Rep. Crow, Jason [D-CO-6]
Recent Actions
- 2025-12-18: Referred to the House Committee on Energy and Commerce.
- 2025-12-18: Introduced in House
- 2025-12-18: Introduced in House
Bill Versions
- NIH Clinical Trial Integrity Act — issued 2025-12-18 — PDF (16 pages)