Reporting Protocol Deviations and Requesting Exceptions
Exceptions. A protocol exception is defined as a circumstance in which the specific procedures called for in a protocol are not in the best interests of a specific subject.
It is the responsibility of the Investigator to request permission from the IRB for planned exceptions to the approved protocol. Exceptions must be approved by the IRB before being implemented. Exceptions may not increase risk or decrease benefit; affect the participant’s rights, safety, or welfare; or affect the integrity of the resultant data.
Deviations. A protocol deviation is defined as a violation that is unanticipated and happens without prior IRB approval. The IRB will review these reports for frequency and may audit any protocol reporting frequent deviations.
It is the responsibility of the Investigator not to deviate from the protocol approved by the IRB, except to avoid an immediate hazard to the participant. The Investigator must submit an amendment request to the IRB and receive written approval prior to implementation of any change to the protocol.
Deviations that increase risk, have potential to recur, or are undertaken to eliminate an immediate hazard would be considered an Unanticipated Problem.
Repetitive deviations may be ruled by the IRB to constitute non-compliance resulting in suspension of IRB approval.
Deviations must be reported to the IRB within 10 business days after the PI becomes aware that the deviation has occurred. Forms for Deviations and Requests for Exceptions are to be completed and filed with the IRB Office. The IRB Office will forward the report to the IRB Chair or designee for review. All deviations will appear on the Board’s next meeting agenda.