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In order to comply with federal, state, and institutional regulations and standards for clinical research billing, the University is responsible for establishing effective processes to ensure that all services for a study are billed properly. These processes can be complex because clinical research often involves multiple entities that are responsible for costs incurred during the course of a trial. During a single visit a research participant may receive routine medical care in addition to services or procedures conducted for research purposes.

UNC adheres to the Centers for Medicare and Medicaid (CMS) regulations for billing to the patient (or a third party on the patient’s behalf) in the context of a research protocol. These regulations require that a study be qualifying and that the costs billed to the patient meet specific criteria. You can NEVER bill for items or services that are paid for by the sponsor, promised free in the informed consent, or are part of a non-qualifying protocol.