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New FDA Guidance – Payment and Reimbursement to Research Subjects

On January 25, 2018, the FDA (Food and Drug Administration) published guidance on payment and reimbursement for research participants.

Paying research participants in exchange for their participation is a common and, in general, acceptable practice. The FDA recognizes payment for participation may raise difficult questions such as undue influence that should be addressed by the IRB.  In contrast to payment for participation, the FDA does not consider reimbursement for reasonable travel expenses associated with participating in a clinical investigation to raise issues regarding undue influence.  Research participation payment (and reimbursement, when applicable) should be credited during appropriate intervals in the clinical investigation, and should not be provisional on completing all the research procedures and visits.  Additionally, payment for early withdrawal (or termination) from the study may be made at the time a research participant would have completed the requirements of the clinical investigation (or a phase of the study) had they not withdrawn.

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