NIH Clinical Trial Integrity Act
Sponsored By: Representative Rep. Kelly, Robin L. [D-IL-2]
Introduced
Summary
Diversity in clinical trials is the core goal of this bill, which makes NIH protocol applicants set measurable recruitment and retention goals and reduces cost and access barriers through studies, training, and outreach.
Show full summary
- Families and participants: Applicants must propose recruitment and retention goals that reflect disease prevalence or the U.S. population by race, ethnicity, age, and sex. Sponsors must report annual aggregate demographic counts and disaggregated retention rates while protecting individual privacy.
- Researchers and sponsors: Applications must include subgroup analysis plans, community partner review, training on health inequities, and alternatives to burdensome follow up like telemedicine or remote testing. NIH can require and publish corrective strategic plans if agreed enrollment targets are missed.
- Communities and outreach groups: Establishes a national public awareness and education campaign with materials, provider curricula, best practices sharing, focus groups, and a grants program for community and nonprofit groups to test outreach strategies. The bill authorizes $10.0 million per year for FY2027–2030 for these activities.
*Authorizes $10.0 million annually for FY2027–2030 for the campaign, which would modestly increase federal spending.*
Your PRIA Score
Personalized for You
How does this bill affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this bill and every other piece of legislation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
New NIH diversity rules for trials
If enacted, sponsors seeking NIH approval would have to set clear recruitment and retention goals by race, ethnicity, age, and sex. Applications would need a written rationale showing how subgroup numbers were calculated and plans to analyze safety and effectiveness by subgroup. Sponsors would also have to describe community engagement, training on diversity and health inequities, and less burdensome follow-up options or explain why alternatives are not possible. The bill would define which studies count as clinical trials and which entities are sponsors.
Reporting, posting, and fix-it rules
If enacted, sponsors would have to share annual, aggregate participant data by race, ethnicity, age, and sex while recruitment is ongoing. Sponsors would report retention rates on request and final participant counts at trial end. The NIH would publish summaries of disease prevalence, trial representation, and stated goals while protecting confidential study design. If agreed targets are missed, sponsors would have 90 days to submit, post, and implement a strategic plan; NIH may provide technical help. Trials already funded by NIH and ongoing at enactment would be exempt, and NIH must list granted waivers. The bill would apply the Affordable Care Act's Section 1557 nondiscrimination rules to covered trials.
National campaign and community grants
If enacted, NIH and the FDA would run a national public education campaign to boost awareness of diverse clinical trial participation. The campaign would make materials, public service announcements, training for health professionals, best-practice guides, and focus groups and would ensure access for people with limited English. The bill would fund grants to nonprofit and community groups to test outreach and cover administrative costs. Congress would be authorized to appropriate $10 million per year for each of fiscal years 2027 through 2030 to carry out the campaign and grants.
Free Policy Watch
You just read the policy. Now see what it costs you.
Pick a topic. PRIA runs your household against live legislation and sends you a free personalized readout.
Pick a topic to get started
Sponsors & CoSponsors
Sponsor
Rep. Kelly, Robin L. [D-IL-2]
IL • D
Cosponsors
Rep. Fitzpatrick, Brian K. [R-PA-1]
PA • R
Sponsored 12/18/2025
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 1/7/2026
Rep. Tonko, Paul [D-NY-20]
NY • D
Sponsored 1/7/2026
Rep. Stansbury, Melanie Ann [D-NM-1]
NM • D
Sponsored 1/7/2026
Rep. Casten, Sean [D-IL-6]
IL • D
Sponsored 1/7/2026
Rep. McClellan, Jennifer L. [D-VA-4]
VA • D
Sponsored 1/7/2026
Rep. Moore, Gwen [D-WI-4]
WI • D
Sponsored 1/7/2026
Rep. Pocan, Mark [D-WI-2]
WI • D
Sponsored 1/7/2026
Rep. Gottheimer, Josh [D-NJ-5]
NJ • D
Sponsored 1/13/2026
Rep. Jayapal, Pramila [D-WA-7]
WA • D
Sponsored 1/15/2026
Rep. Crow, Jason [D-CO-6]
CO • D
Sponsored 1/21/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.govTake It Personal
Get Your Personalized Policy View
Take the PRIA Score to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in