Sponsors (12)
The bill would improve representation, data quality, and participant support in clinical trials—benefiting historically underrepresented patients—but does so at the cost of higher sponsor and federal administrative burdens, potential delays and added legal risk, and modest new federal spending.
Patients from racial/ethnic minority groups, women, and older adults will see increased representation in NIH‑funded/approved clinical trials, producing stronger safety and effectiveness data for those subgroups.
Trial participants (especially people with chronic conditions, caregivers, and those with limited time/money) will face lower time and cost barriers through flexible follow‑up options (telemedicine, fewer visits, local labs, evening/weekend hours).
Community organizations, community pharmacies, and local outreach programs will receive grant funding to pilot outreach strategies and cover administrative costs, supporting recruitment of underrepresented participants.
Clinical trial sponsors and developers (including small businesses) may face higher costs and longer timelines to meet subgroup enrollment and reporting requirements, which could slow product development and raise prices for patients and taxpayers.
Sponsors of smaller or early‑phase trials and the participants they serve could be disadvantaged if those studies cannot meet subgroup targets, leading to waivers, added exclusions, or difficulty obtaining NIH approval.
Sponsors, research institutions, and federal agencies will face added administrative and data‑management burdens from annual demographic reporting, remediation plans, grant administration, and program implementation.
Based on analysis of 5 sections of legislative text.
Requires NIH-reviewed clinical trial protocols to set measurable recruitment/retention goals by race/ethnicity/age/sex, plan subgroup analyses, study human-subjects payment rules, and fund outreach grants and education.
Official title: To 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 Robin L. Kelly · Last progress December 18, 2025
Requires NIH-reviewed clinical trial protocols to include clear, measurable recruitment and retention goals by race, ethnicity, age, and sex that match disease prevalence (or U.S. population if unknown), a rationale for subgroup counts, and plans for separate subgroup analyses and less-burdensome follow-up options. Directs NIH to study updating human-subjects protections and payment/reimbursement guidance, launches a national education/outreach campaign with a grants program to improve recruitment of underrepresented groups, and authorizes $10 million annually for FY2027–2030 for that campaign.