This bill requires that clinical trials funded by the National Institutes of Health (NIH) include diverse participants that reflect the racial, ethnic, age, and sex makeup of the patient population being studied—or the general U.S. population if the disease prevalence isn't known. When research organizations apply for NIH funding to conduct clinical trials, they must now submit clear recruitment goals, explain their strategy for reaching different demographic groups, and show how they'll analyze results separately for each group to ensure the drug or treatment actually works the same way for everyone.

The bill also tackles practical barriers that keep people from participating in trials. It requires researchers to consider less burdensome follow-up options like phone check-ins, home visits, telemedicine appointments, and flexible scheduling instead of requiring everyone to come in person repeatedly. Within two years, the NIH must study whether current rules about paying participants for their time and reimbursing their expenses need updating. Additionally, the government will launch a national awareness campaign—with $10 million in funding through 2029—to educate the public, healthcare providers, and community organizations about the importance of diverse clinical trials and how to participate. The campaign will include translated materials for people with limited English proficiency and will work with community groups, faith organizations, and pharmacies to reach underrepresented populations.