The informed consent (ICF) and clinical trial contract (CTA) are required to address the issue of who bears financial responsibility for costs incurred in diagnosing and treating study-related injuries.
Sometimes, industry sponsors will propose language that indicates the sponsor will pay for study-related injuries only if the patient’s insurance denies payment. The Institution will not accept such language or similar language that requires that Institution to bill the third-party insurance companies or the research subjects in lieu of recovery of such costs from the sponsor. In such cases, the conditional language must be removed.