Tax and Legal Considerations for Compensation Programs for Clinical Trial Participants

This document evaluates the three main approaches to providing financial support to clinical trial participants for non-medical costs: reimbursement, prepayment, and stipends.

Each of these approaches raises a variety of ethical and legal considerations for sponsors and patients, including concerns about inducement, anti-kickback restrictions, tax implications, and impact on eligibility for safety net programs.

The report concludes that most of the perceived and real risks for the various stakeholders could largely be mitigated by implementation of policy solutions outlined in this brief.