NIH Clinical Trial Integrity Act
Summary
What This Bill Does
The bill requires applicants for NIH-approved or NIH-funded clinical trials to submit measurable recruitment and retention goals reflecting the disease population, or the general United States population when prevalence is unknown, by race, ethnicity, age, and sex. Sponsors must explain their rationale, detail recruitment plans, use less burdensome follow-up, provide diversity training, and submit corrective strategic plans if goals are missed. HHS and NIH must study participant reimbursement, compensation, incentives, and fraud-and-abuse safe harbor issues, while HHS, NIH, FDA, and stakeholders must run an awareness campaign with materials, public service announcements, professional curricula, limited-English-proficiency access, best practices, training, grants, and reporting.
Who Benefits and How
Underrepresented patients, clinical trial participants, community organizations, health care professionals, and researchers benefit from more representative recruitment goals, lower participation barriers, and public education about trial access.
Who Bears the Burden and How
NIH-funded clinical trial sponsors must comply with recruitment goals, training, follow-up, and corrective-plan requirements, while NIH reviewers, FDA campaign staff, HHS policy staff, and GAO auditors must perform review, study, outreach, grant, and reporting work.
Key Provisions
- Requires NIH clinical trial applications and renewals to include measurable diversity recruitment and retention goals.
- Directs HHS and NIH to study reimbursement, compensation, incentives, and safe-harbor issues that affect trial participation costs.
- Authorizes a public education campaign on diverse clinical trial participation with stakeholder materials, professional training, and community outreach.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Requires NIH-funded clinical trial sponsors to set measurable participant-diversity goals and directs HHS to study cost barriers and run a public education campaign on diverse clinical trial participation.
Key Policy Areas
Healthcare, Research & Science, Government, Education
Primary Purpose
Requires NIH-funded clinical trial sponsors to set measurable participant-diversity goals and directs HHS to study cost barriers and run a public education campaign on diverse clinical trial participation.
Policy Domains
Substantive provisions
Identified Gains
- Underrepresented clinical trial participants
- Community organizations
- Health care professionals
- Clinical researchers
Identified Costs
- NIH-funded clinical trial sponsors
- NIH reviewers
- FDA campaign staff
- HHS policy staff
- GAO auditors
Sponsors
Legislative Progress
In CommitteeMs. Kelly of Illinois (for herself and Mr. Fitzpatrick) introduced …
Referred to the House Committee on Energy and Commerce.
Introduced in House
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
FDA campaign staff, HHS policy staff, NIH outreach staff
Clinical trial participants with travel costs, Health care professionals, Underrepresented clinical trial participants
Positive-direction: Clinical trial participants with travel costs, Underrepresented clinical trial participants
Negative-direction: Health care professionals
Clinical researchers, Clinical trial sponsors, NIH-funded clinical trial sponsors
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology