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Increasing Diversity in Clinical Trials: New Rules and Participant Support.

This act aims to boost diversity in clinical trials funded by the National Institutes of Health. This means drug and medical device studies will better reflect the population's diversity, potentially leading to safer and more effective treatments for everyone. The act also introduces measures to make trial participation less burdensome for individuals.
Key points
Clinical trials must set clear goals for participant diversity based on race, ethnicity, age, and sex, reflecting either the patient population or the general U.S. population.
Research organizations will need to submit detailed plans for recruiting and retaining diverse participant groups and analyze data separately for these groups.
Less burdensome follow-up options will be implemented for trial participants, such as phone calls, home visits, online options, or wearable technology, to make participation easier.
A public awareness campaign will be launched to educate people about the importance of diversity in clinical trials and encourage participation.
A study will be conducted on reimbursing out-of-pocket expenses and compensating participants for their time to remove financial barriers.
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Expired
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Additional Information
Print number: 117_S_5268
Sponsor: Sen. Menendez, Robert [D-NJ]
Process start date: 2022-12-15
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

NIH Clinical Trial Diversity Act of 2022

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_5268.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2022-12-15.

What are the main provisions?

Key points include:

  • Clinical trials must set clear goals for participant diversity based on race, ethnicity, age, and sex, reflecting either the patient population or the general U.S. population.
  • Research organizations will need to submit detailed plans for recruiting and retaining diverse participant groups and analyze data separately for these groups.
  • Less burdensome follow-up options will be implemented for trial participants, such as phone calls, home visits, online options, or wearable technology, to make participation easier.
  • A public awareness campaign will be launched to educate people about the importance of diversity in clinical trials and encourage participation.
  • A study will be conducted on reimbursing out-of-pocket expenses and compensating participants for their time to remove financial barriers.
What is the specific legal status?

The current status is Expired.

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 Sen. Menendez, Robert [D-NJ].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-29.

CATEGORIES

Health