Question: Can the IRB approve reimbursement of copays for routine costs in a clinical trial?

Question:

Will an IRB allow reimbursement for co-pays for routine patient care costs associated with participation in a clinical trial when the costs are covered by insurance, but the subject is responsible for a high co-pay? Examples of these costs include extra blood tests, scans, or administration of medication other than the study drug.
- Principal consultant

Response:

The IRB can approve this but there may be other parties that have to weigh in. While it is not ethically objectionable to reimburse out of pocket expenses for research participation, there may be potential legal issues with reimbursement of co-pays. It is illegal to pay for co-pays under Medicare, and many private insurers have elected to follow suit. As a result, having a research sponsor reimburse co-pays could lead to legal issues for the research physician and the insured individual. 

About the Author

David Borasky, MPH, CIP | VP of IRB Compliance

In addition to his compliance oversight responsibilities at WCG, Mr. Borasky also serves as Co-Chair of the Subpart A Subcommittee of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) former member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R).

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