Politiparty
Politiparty
LeaderboardCongressBills

118th Congress Health

H.R. 3503: NIH Clinical Trial Diversity Act of 2023

Introduced

  1. Introduced (completed)May 18, 2023
  2. Passed House (not reached)
  3. Passed Senate (not reached)
  4. To the President (not reached)
  5. Became law (not reached)

Summary

Introduced in House, May 18, 2023

This bill sets out requirements to increase the diversity of clinical trial participants and requires other activities to foster participation in clinical trials.

As a condition of approval from the National Institutes of Health (NIH) for a clinical trial investigating a drug, device, or behavioral intervention, a sponsor's application must include certain information related to diversity in its trial, such as

  • goals for recruiting and retaining trial participants,
  • plans for achieving the recruitment and retention goals and implementing less-burdensome clinical trial follow-up requirements, and
  • requirements for researchers and other individuals involved with the trial to complete education and training about diversity in clinical trials.
Read the full summary

A sponsor must also annually share demographic data of clinical trial participants with the NIH. The NIH must publish on its website information about the diversity of and other information concerning the clinical trials it funds.

If a sponsor fails to meet its diversity goals or related requirements, the sponsor must develop and implement a strategic plan to increase the diversity of the clinical trial participants.

Further, the NIH and the Food and Drug Administration must carry out a national campaign to increase awareness about the need for diverse clinical trials.

The bill also requires studies on barriers to participation in clinical trials. The Government Accountability Office must study actions taken by federal agencies to address such barriers while the NIH must study regulations that govern reimbursements of out-of-pocket expenses of and incentives for clinical trial participants.

Written by the Congressional Research Service, Library of Congress.

Roll calls

0 votes on this bill

No roll call votes have been held on this bill.

Amendments

0 offered

No amendments were offered to this bill.

Cosponsors

40

Bipartisan support.

Who scored on this bill

12 points earned
  1. 1Robin Kelly D-IL SponsorDrew cross-party cosponsors, introduced, reached a cosponsor milestone3 events+12
See all scorers and every scoring event

Introductions and cosponsorships count toward weekly caps and show no points.

Other bills by Robin Kelly

History

  1. May 18, 2023Introduced in the House by Robin Kelly.
Show the full action history (3 actions)
  1. May 19, 2023Referred to the Subcommittee on Health.
  2. May 18, 2023Introduced in House
  3. May 18, 2023Referred to the House Committee on Energy and Commerce.