Sponsors (2)
Official title: Direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes.
Introduced December 18, 2025 by Andy Kim · Last progress December 18, 2025
The bill aims to increase diversity, clarity, and protections in clinical trials—improving access and oversight for underrepresented participants—while imposing new reporting, compliance, and funding burdens that could raise costs, slow some research, and create privacy or incentive risks.
Underrepresented people (racial/ethnic minorities, women, older adults, those with limited English proficiency and disabilities) will be more likely to enroll in clinical trials because of strengthened recruitment requirements, outreach grants, training, and less-burdensome follow-up options that lower practical barriers.
Researchers, institutions, and federal agencies (NIH/HHS) will get clearer, standardized definitions and more disaggregated demographic reporting, improving oversight, targeting of interventions, and consistency about which studies are covered.
Patients—especially those with chronic conditions, low-income participants, caregivers, and older adults—will face lower participation burdens and financial barriers thanks to allowance of less burdensome follow-up methods and updated guidance on reimbursing out-of-pocket expenses.
Research institutions, sponsors, and investigators will face increased administrative, reporting, and compliance costs (including from new demographic reporting and possible reclassification of studies), which can delay study starts and raise overall trial costs.
Smaller or early‑phase trials and community groups with limited capacity may struggle to meet subgroup enrollment expectations or compete for grants, risking reduced funding, exclusion, or infeasible burdens for small studies and organizations.
Annual sharing of disaggregated demographic data and potential changes to compensation rules raise privacy and inducement risks—participants could face higher re-identification risk, and looser safe-harbors or incentives could create improper inducements to enroll.
Based on analysis of 5 sections of legislative text.
Requires NIH-funded clinical trial applicants to set/justify demographic recruitment goals, report disaggregated data, complete diversity training, study human-subjects rules, and fund outreach grants.
Requires organizations running NIH-funded clinical trials to set and justify measurable recruitment and retention goals for race, ethnicity, age, and sex; to report disaggregated demographic recruitment and retention data; and to complete diversity training as a condition of NIH funding. Directs HHS/NIH to study whether human-subjects regulations and anti-kickback safe harbors should be updated for reimbursement, compensation, and recruitment incentives, and creates a national outreach/education campaign plus grants (authorized at $10M/year 2026–2029) to improve trial diversity.