Bill > HR3521

This bill aims to modernize clinical trials and increase participation by underrepresented populations through several key provisions. First, it establishes a grant program to support community education, outreach, and recruitment activities for clinical trials, with a focus on diseases that disproportionately affect underrepresented groups. The grants will prioritize entities that develop multilingual materials and conduct outreach in traditionally underrepresented communities. The bill also modifies existing laws to allow clinical trial sponsors to provide financial support to participants, including reimbursement for expenses like travel and meals, and free digital health technologies to facilitate participation. Additionally, the legislation clarifies that sponsors can help participants with cost-sharing obligations without violating anti-kickback statutes, provided certain protective conditions are met. The bill further provides a tax benefit by excluding up to $2,000 of clinical trial participation remuneration from an individual's gross income. Throughout the bill, "underrepresented populations" are defined using guidelines from the National Institutes of Health and the Food and Drug Administration, with the overall goal of making clinical trials more accessible, diverse, and inclusive.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/3521/all-info