Sponsors (2)
The bill meaningfully increases clinical-trial inclusion and reduces participation barriers for underrepresented and underserved patients—at the cost of added federal spending, greater administrative and enforcement complexity, and risks of privacy, undue influence, and uneven implementation.
Underrepresented groups (racial/ethnic minorities, tribal communities, rural and low-income patients, people with disabilities) are more likely to be recruited and included in clinical trials, improving representativeness of results and access to experimental therapies.
Patients from underserved communities (including Medicare/Medicaid beneficiaries) face lower financial and logistical barriers because sponsors can cover travel, meals, digital tools, and allowable out-of-pocket cost‑sharing, making participation more feasible.
Community clinical sites, community health centers, and training programs can gain funding and partnerships that strengthen local research capacity, expand convenient access to trials, and diversify the investigator workforce.
Taxpayers and federal programs face increased costs from new appropriations, greater CMS-covered service use, potential abusive billing exposure, and lost revenue from the participant tax exclusion.
Researchers, sponsors, providers, and regulators may face new and shifting administrative and compliance burdens and ambiguity (changing definitions of 'underrepresented,' IRS reporting complexity, uncertain boundaries around permissible inducements).
Increased outreach, provision of devices, or payments could raise privacy, data-security, and informed-consent risks for participants if safeguards and oversight are inadequate.
Based on analysis of 7 sections of legislative text.
Authorizes HHS grants to increase enrollment of underrepresented groups in clinical trials, allows certain participant payments and digital tools, permits manufacturer cost-sharing with safeguards, and excludes up to $2,000 of participant payments from tax.
Official title: Modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes.
Introduced April 29, 2026 by Tim Scott · Last progress April 29, 2026
Creates a new HHS grant and contracting program to boost enrollment of underrepresented populations in clinical trials for drugs, devices, and vaccines and authorizes funding for FY2027–FY2028. It changes federal fraud-and-abuse law safe harbors to allow certain payments, travel support, and free digital health technologies to help underrepresented people participate in trials, permits manufacturers to pay participant cost-sharing under strict safeguards, and excludes up to $2,000 per year of clinical trial payments from individual taxable income. The bill adds definitions aligned with NIH and FDA guidance, sets program priorities (multilingual outreach, tribal and rural communities), requires IRB and investigator safeguards for manufacturer cost-sharing, and clarifies that the new exceptions do not limit other existing liability protections. Some provisions take effect on enactment; the tax exclusion applies to taxable years after enactment and grant funding is authorized for FY2027–FY2028.