Summary

Makes NIH approval for new clinical trials conditional on sponsors setting clear, measurable recruitment and retention goals by race, ethnicity, age, and sex and submitting plans to achieve and analyze those goals. Requires ongoing demographic reporting, public summaries of representation, remediation plans when targets are missed, and privacy protections. Requires a study on updating human-subject payment rules and safe-harbor guidance, and funds a national education campaign plus grants to community organizations to increase trial diversity (authorized $10M/year FY2027–2030).

Key Points

• NIH clinical trial approval becomes conditional on sponsors setting measurable recruitment and retention goals by race, ethnicity, age, and sex.
• Sponsors must submit strategies to meet goals, reduce participant burden, require investigator training, and report demographics annually during recruitment and finally after the trial.
• NIH must publish disease prevalence, trial representation versus goals, and remediation plans when targets are missed; sponsors must submit and publish remediation plans within 90 days.
• NIH must study updating human-subject payment and incentive rules and anti-kickback safe-harbor guidance within two years.
• A national education campaign plus a grant program for community and nonprofit organizations will support outreach and best practices; $10M/year is authorized for FY2027–2030.
• Section 1557 nondiscrimination protections apply to covered trials and privacy protections are required for demographic data.
• Ongoing NIH-funded trials at enactment are exempt, but waivers must be listed in a triennial report.
• GAO will study federal actions to reduce barriers for specified demographic groups and report to Congress within one year.
• Many requirements could increase administrative burden and operational costs for trial sponsors and may affect trial timelines.
• Implementation depends on future appropriations and NIH/FDA rulemaking and guidance updates.

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