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NIH Clinical Trials Diversity Act: Ensuring Fair Representation in Medical Research.

This Act mandates that sponsors of NIH-approved clinical trials must set measurable goals to recruit participants reflecting the race, ethnicity, age, and sex of the affected population. The goal is to ensure that new drugs and treatments are tested on diverse groups. It also requires sponsors to submit a plan for implementing less burdensome follow-up options, such as virtual or home visits, or to explain why such options cannot be implemented.
Key points
Mandatory diversity goals for clinical trial recruitment (race, ethnicity, age, sex) to match disease prevalence in the US population.
Requirement for sponsors to plan for flexible participation options (e.g., telemedicine, home visits) or explain why they cannot be implemented.
Study required on modernizing rules for reimbursing participants' out-of-pocket expenses and compensating them for time spent in trials.
Authorization of a national public awareness campaign regarding diverse clinical trials, with $10 million authorized annually for fiscal years 2027 through 2030.
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Introduced
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Additional Information
Print number: 119_HR_6867
Sponsor: Rep. Kelly, Robin L. [D-IL-2]
Process start date: 2025-12-18
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Summarized by: gemini-3-pro-preview
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OFFICIAL LEGAL TITLE

NIH Clinical Trial Integrity Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_HR_6867.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2025-12-18.

What are the main provisions?

Key points include:

  • Mandatory diversity goals for clinical trial recruitment (race, ethnicity, age, sex) to match disease prevalence in the US population.
  • Requirement for sponsors to plan for flexible participation options (e.g., telemedicine, home visits) or explain why they cannot be implemented.
  • Study required on modernizing rules for reimbursing participants' out-of-pocket expenses and compensating them for time spent in trials.
  • Authorization of a national public awareness campaign regarding diverse clinical trials, with $10 million authorized annually for fiscal years 2027 through 2030.
What is the specific legal status?

The current status is Introduced.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Kelly, Robin L. [D-IL-2].

What is the latest detailed status?

The latest detailed status is: Referred to the House Committee on Energy and Commerce.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2026-01-23.

CATEGORIES

Health