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Community Response to RFI on the Creation of Clinical Trial Support Safe Harbor

August 24, 2026

ACS CAN was joined by 128 other organizations in responding to an HHS request for information (RFI) related to the creation of a new safe harbor from the Anti-Kickback Statute related to clinical trial participation. The letter called for HHS to create a safe harbor that would allow trial sponsors to provide financial support to clinical trial patients to offset additional costs of participating.  Financial considerations are a common reason that individuals decide not to participate in trials, and this barrier is especially problematic for rural residents and those with lower incomes.