- Deviations and Exceptions - IRB Review of Changes SOP (3/15/19) [PDF]
- Protocol Violation Review SOP (Revised 8/19/09) [PDF]
- Unanticipated/Anticipated Problem/Adverse Event Reporting SOP (Revised 7/8/11) [PDF]
- IRB Policy on Unanticipated Problem and Safety Reporting (Policy Effective 6/15/06; Revised 5/10/18) [PDF]
Deviation: A one-time departure from the current IRB approved protocol once a subject has actually been enrolled is considered a protocol deviation. Examples: drawing a 13th tube of blood from a subject where the protocol specifies that 12 samples will be collected for the study; or, instituting a procedure on one or more enrolled subjects that is not specified in the protocol.
Exception: A one-time enrollment of a research subject in a protocol that fails to meet current IRB approved protocol inclusion criteria, or falls under protocol exclusion criteria, is considered a protocol exception. Examples: enrollment of a 70 year old patient when the inclusion criteria specifies 25-65 years of age; or, enrollment of a patient with a serious disease that is precluded from participation in the protocol exclusion criteria.
It is IRB policy that deviations and/or exceptions to IRB approved protocols be reviewed and approved prior to their implementation. Most sponsors also require approval prior to implementation of any deviations from the protocol. For Exemption Applications approved external to E-IRB, use the IRB's Modification Request Form and submit it to IRBsubmission@uky.edu. If the protocol is approved in E-IRB, please see the E-IRB Video Tutorial on how to create a deviation or exception and follow the instructions.
Please note, a deviation and/or exception should be a one-time event and IRB approval for its implementation does not change the entire protocol.
Modification Request Form:
A protocol violation is any exception or deviation involving a single subject that is not approved by the IRB prior to its initiation or implementation. These protocol violations may be major or minor violations. If either a protocol deviation or protocol exception occurs without prior IRB review and approval, the Principal Investigator is responsible for completing a Protocol Violation (PV) Report Form and submitting it to the IRB within 14 days of the occurrence. For Exemption Applications approved external to E-IRB, the Protocol Violation Report should still be submitted electronically in PDF format to IRBSubmission@uky.edu. If the protocol is approved in E-IRB and a PV needs to be reported, view the E-IRB Video Tutorial on how to create a Protocol Violation Report and follow the instructions. If applicable, the Principal Investigator is responsible for reporting protocol violations to the sponsor, and/or FDA.
How to prepare your Protocol Violation e-mail IRB submission [PDF]
Protocol Violation Reporting Form:
Unanticipated Problem/Safety Reporting
If an Unanticipated Problem/Safety Report needs to be submitted on an E-IRB protocol that is approved or pending review/approval in E-IRB, review the E-IRB Video Tutorial on how to create an Unanticipated Problem Report and follow the instructions.
For Exemption Applications approved external to E-IRB, the Unanticipated Problem/Safety Report should still be submitted electronically in PDF format to IRBSubmission@uky.edu.
UK IRB Policy on Unanticipated Problem and Safety Reporting [PDF]
Internal Prompt Reporting Form [PDF]
External Prompt Reporting Form [PDF]
Non-Prompt Reporting of Problems/Events [PDF] (If sponsor requires the PI to submit reports that do not require reporting according to UK's policy)