NIH Clinical Trial Integrity Act

Key Points

• Sponsors of NIH-approved clinical trials would have to set clear goals to enroll and keep participants that match the disease’s patient mix (or the U.S. population if unknown).
• Trial sponsors would have to regularly share participant counts and retention rates broken out by race, ethnicity, age, and sex, with privacy limits on shared data.
• If a trial misses its diversity goals by an agreed date, the sponsor must create and then carry out a public plan (with community groups) to improve participation.
• HHS would study ways to reduce cost barriers for volunteers, like paying back out-of-pocket costs and compensating people for their time, and whether rules need updating.
• HHS and FDA would run a national education campaign and give grants to nonprofits to boost awareness and recruitment; the bill authorizes $10 million a year for 2027–2030.