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.

Votes

No votes have been recorded for this legislation yet.

News

No related news coverage found for this legislation yet.

Related Bills

No related bills have been identified yet.