Deductibles and Co-Pays for Protocol Visits What should the informed consent language include to communicate financial obligations for billable protocol services to study subjects?The informed consent form should include sufficient detail for the subjects to delineate protocol items/services that are research-only provided at no cost, protocol services that are ordinary care or routine costs that will be billed to the subjects and their insurance, or otherwise indicate when the study will cover all costs including the routine care required for the study.3 | |
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