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Mandating Diversity and Reducing Burden in NIH-Funded Clinical Trials.

This Act requires NIH-funded clinical trials to set clear goals for recruiting participants that reflect the race, ethnicity, age, and sex of the population affected by the disease. The goal is to ensure that new treatments are proven safe and effective across all demographic groups. Furthermore, it mandates that researchers offer less burdensome follow-up options, such as virtual visits or local lab testing, making participation easier for citizens.
Key points
NIH-funded trials must establish measurable goals to ensure participant diversity reflecting the affected patient population (race, ethnicity, age, sex).
Researchers must implement flexible follow-up options (e.g., virtual visits, home visits, evening hours) to reduce the time and cost burden on trial participants.
HHS must study how to modernize rules regarding reimbursement for out-of-pocket expenses and compensation for participants' time in trials.
A national public awareness campaign will be launched to educate citizens and healthcare providers about the importance of diverse clinical trial participation.
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Introduced
Citizen Poll
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Additional Information
Print number: 119_S_3564
Sponsor: Sen. Kim, Andy [D-NJ]
Process start date: 2025-12-18