Author: Meredith M. Hoog

Saint Louis University Institutional Review Board
Protocol Violation (PV) Decision Tree

Did the event occur at SLU or a SLU affiliated site?

No

Yes

Event is not reportable to SLU IRB.

Is the event related or possibly related to participation in the research?

No

Yes

Did the event place participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than if the protocol was followed as intended?

Yes

No

Did the event involve any of the following?
An unintentional variation from the approved research protocol
An error in the conduct of the study
Failure to get IRB approval prior to implementation of a protocol deviation
A reportable consent violation

Did the variation involve a reportable consent violation or the implementation of a protocol deviation without prior IRB approval?

Yes

No

No

Event is not a reportable PV.

Yes

Event is a PV.
Report to IRB within 7 days from the date the violation becomes known.

Event is not a reportable PV.

PVs should be reported on the Report Form in eIRB. Submit the Change-in-Protocol/For Information Only form if the study is not in eIRB.
PVs that result in SAEs are to be reported in accordance with SAE required timelines.
If the PV results in the death of a subject, notify the IRB immediately at 977-7744 or irb@slu.edu.

Version Date: 4/2017