It is best to advise study subjects of their financial obligations specific to their study participation by:
Providing clear and specific language in the informed consent form describing subjects’ responsibility for deductibles/copayments/co-insurance for billable care rendered at the study visits just as for any ordinary care visit
Reviewing these responsibilities during the consenting process and explaining that the study team has no discretion to waive their deductible/copayments for billable care provided at study visits.
The study subject’s copayments, co-insurance and deductibles related to clinical study protocol services that are billed to insurance are handled just as they would be for ordinary care. Waiver/payment of the subject’s financial responsibility is generally not appropriate unless specific policy criteria are met, such as the hospital financial assistance policy.
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.