What is a “protocol waiver” or “protocol exception”?

A protocol “waiver” or “exception” is an intentional deviation from the approved protocol, such as the enrollment of a participant in violation of the protocol’s inclusion/exclusion criteria. Most sites realize that it is necessary to obtain the sponsor’s approval prior to implementing a protocol waiver. It is also necessary, however, to obtain the IRB’s approval prior to implementing a protocol waiver, unless the change is deemed necessary to eliminate an apparent immediate hazard.