Such applications should explain what plans are available if denial of payment should occur. The Institutions are concerned with coverage of possible medical care costs from unanticipated side effects caused by investigational drugs or devices used as part of a research study. Patients or volunteers who participate in human subjects research protocols should not be placed at risk of incurring medical care bills should they require treatment for an unanticipated adverse event. Therefore, commercial sponsors of research protocols must provide an indemnification agreement which states that the sponsor will provide the cost of reasonable medical care for treatment of a research- related injury caused by the investigational product. Prompt submission to the ORA will avoid withholding of the approved consent form while administrative details are worked out.
Acceptable agreements are on file for several sponsors.
Appendix K offers a sample of a master agreement and a sample protocol-specific indemnification agreement. In the event that a sponsor will not provide an acceptable indemnification agreement, the JCCI will forward the matter to the Ethics and Economics Committee. If the Ethics and Economics Committee should determine that a waiver from the indemnification requirement is not appropriate, and the sponsor will not alter their position, then the study described in the RPN may not be conducted at the Institutions.