The IRB would only very rarely take action in regards to the cost of an investigational device due to 21 CFR 812.7, which prohibits the commercialization of an investigational device by charging participants a price greater than that is necessary to recover costs of manufacture, research, development, and handling.
An IRB, however, may ask for additional rationale for the cost of the device if the cost is considered exceptionally high and the prospect of benefit is low or the participant has no available alternative therapies. In either circumstance, the IRB would be concerned that there could be the possibility of undue influence (therapeutic misconception) or coercion (lack of choices) and thereby an inability to obtain legally effective informed consent.
