Sponsors (12)
The bill aims to make clinical trials more inclusive and generate better evidence for diverse patients—improving access and data quality—while imposing higher costs, greater administrative and legal burdens, and potential challenges for small or early‑phase studies and taxpayers.
Patients from underrepresented groups (racial/ethnic minorities, women, older adults) will see increased representation in NIH‑approved trials, producing more reliable safety and effectiveness data for diverse populations.
Trial participation will become less burdensome (telemedicine, fewer visits, local labs, evening/weekend hours), lowering time and cost barriers for patients and increasing who can realistically enroll.
Public reporting of enrollment goals, ongoing demographic reporting, and remediation plans will let communities, advocates, and regulators monitor trial equity and hold sponsors accountable.
Sponsors and trial organizers will likely face higher trial costs and longer timelines to meet subgroup enrollment, reporting, and remediation requirements, which could slow product development and raise downstream prices.
New and recurring reporting, monitoring, and grant-administration duties create added administrative burdens and data‑management costs for sponsors, NIH/HHS/FDA staff, and trial sites.
Smaller or early‑phase trials may struggle to meet subgroup targets, potentially causing waivers, exclusions, or barriers to NIH approval and limiting research on rare conditions or early-stage interventions.
Based on analysis of 5 sections of legislative text.
Requires NIH-approved trial protocols to set measurable diversity recruitment/retention goals, subgroup analysis plans, low-burden follow-up options, funds outreach grants, and studies participant compensation rules.
Introduced December 18, 2025 by Robin L. Kelly · Last progress December 18, 2025
Requires NIH approval for clinical trial protocols to include clear, measurable recruitment and retention goals and plans to ensure participant diversity by race, ethnicity, age, and sex, plus subgroup analysis and community engagement strategies. Directs NIH to study modernizing human-subjects protections and compensation rules, and funds a national public education and outreach campaign with grants to community organizations to boost participation from underrepresented groups.