15. Protections from Medical Expenses

The Common Rule does not require payment or reimbursement of medical expenses, provision of medical care, or compensation for research-related injuries. For studies that involve more than minimal risk, informed consent requires an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.  (32 CFR § 219.116(a)(6)). Every Navy research project involving greater than minimal risk shall include an arrangement for emergency treatment and necessary follow-up of any research-related injury. (SECNAVINST 3900.39D(6)(a)(5)).   The IRB application for Navy projects must specify (a) whether any compensation is available if injury occurs and (b) a plan for emergency treatment and necessary follow-up of any research related injury.