Clinical Trial Participation & Access

Current understanding

Federal policy is exploring ways to reduce financial and legal barriers to clinical trial participation, particularly for underrepresented populations. Proposals include grant programs for community outreach, anti-kickback safe harbors for trial-related expense reimbursement, and tax exclusions for participant compensation. Status is early-stage legislative activity (introduced bills) rather than enacted law.

Evidence log

• 2025-02-10 — HALT Fentanyl Act: cross-connection with drug-scheduling-controlled-substances: HALT Fentanyl Act pairs permanent class scheduling of fentanyl-related substances with eased DEA Schedule I research registration requirements, linking controlled-substance enforcement policy to clinical research access. (novelty: 3)
• 2026-07-23 — A bill to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes.: 2026 — S5127 introduced to amend the Internal Revenue Code to exclude certain compensation paid to clinical trial participants from gross income, a standalone codification of the tax-exclusion component previously seen in broader trial modernization bills. (novelty: 2)
• 2026-07-16 — Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026: 2026 — ALS Critical Therapies Reauthorization Act (S4472) introduced; extends federal programs that facilitate access to investigational therapies for ALS patients, an access pathway adjacent to conventional clinical trial enrollment. (novelty: 2)
• 2026-07-09 — Accelerating Innovation (AI) for Kids with Cancer Act: 2026 — AI for Kids with Cancer Act (HR9632) (citation removed): Introduced bill to promote AI-driven innovation for pediatric cancer; could intersect with trial access if implementation includes AI-enabled trial matching or eligibility tools, though specifics are not yet public. (novelty: 3) (novelty: 3)
• 2026-04-29 — Clinical Trial Modernization Act: Clinical Trial Modernization Act (introduced) would combine three interventions to reduce barriers: grants for outreach to underrepresented communities, anti-kickback exemptions for participant expense reimbursement and digital health tools, and a federal income tax exclusion on up to $2,000 of trial compensation. (novelty: 3)
• 2025-05-20 — Clinical Trial Modernization Act: cross-connection with anti-kickback-safe-harbors: Proposed clinical trial expense exemption would create a new anti-kickback safe harbor category specifically for trial participation. (novelty: 3)

Open questions

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