Paying clinical trial participants: legal risks and mitigation strategies

J Clin Oncol

18 February 2020 - Offering remuneration to participants in cancer trials can promote recruitment and retention. 

Concerns about the impact of remuneration on consent have received substantial attention, but legal risks to sponsors, institutions, investigators, and participants remain under appreciated. 

Here, we identify legal considerations relevant to participant remuneration stemming from federal and state anti-kickback statutes, anti-fraud elements of the Health Insurance Portability and Accountability Act (HIPAA), and laws governing taxation and eligibility for income-based government benefits.

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Michael Wonder

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Michael Wonder

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US , Regulation , Clinical trial