SecBot SecBot

NIH Clinical Trial Diversity Act of 2023

H.R. 3503 Rep. Robin Kelly (D-IL-2) In committee
Bill text PDF
  1. Introduced May 18
  2. Committee May 18
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, May 18, 2023Next: House vote
1258d ago May 19, 2023: Referred to the Subcommittee on Health.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
1company, 2 filings
Subscribe to see spend
Member trades
5trades in the last 90 days
Subscribe to see who
Who backs the bill and who pushes back Subscribe

Companies lobbying on this bill

1 company
Companies by sector
Biotech & Pharma 1
Search all 1 companies, their asks and price moves Subscribe

Summary

NIH Clinical Trial Diversity Act of 2023

Full summary9 paragraphs

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.

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.

Library of Congress summary, May 18, 2023

Summary versions
  • Introduced in HouseMay 18, 2023

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.