Protocol Deviations
Unanticipated problems emerge when there is a variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual activities being performed. Reporting violations or deviations of a protocol are required to be made, in writing, to the IRB. (45 CFR 46.103(5)) Pursuant to federal regulations, the responsibility for reporting such noncompliance issues extends to principal investigators as well as any National Jewish faculty or staff that becomes aware of the noncompliance occurrence.
Protocol Deviation Form
Protocol Deviation Form Instructions
Protocol Deviations/Violations reporting Flowchart
Unanticipated Problems Policy
