- 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]
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) - Prompt/NonPrompt Reporting [PDF]
Instructions for Responding to a Request
For detailed instructions on how to respond, you may wish to review the video tutorial "Other Reviews - Respond to a Request for Revisions or Additional Info."
Otherwise, to see what was requested, please access your “Inbox” in E-IRB, go to the "Other Reviews" tab, and click on the "Modify Other Review" task button for the applicable study. In the window that opens, select "Review Notes" in the left-hand menu.
- If the request is for additional information, you may edit the information directly on the "Modify Other Review" page, and re-submit it. No further action is required unless "2" below also applies.
- If the request is to revise a component of the study, start a new Modification Request in E-IRB to incorporate the requested changes and submit (or if a Continuation Review(CR)/Annual Administrative Review (AAR) is due, incorporate the applicable changes into it).
- If revisions to the assent/consent/authorization form(s) are necessary, please underline or highlight each change or addition which has been made to the form(s) and attach it as a "Highlighted" document type. Also, attach one clean copy of the revised consent/assent/authorization form(s), (i.e., do not highlight or underline this copy) and assign the applicable "document type" to it. If approved, the clean form(s) will be returned to you with a valid "IRB Approval" stamp.
- Re-submit the "Other Review," preferably with a memo or 'Review Note' to indicate you are submitting (or have submitted) the requested revisions via a Modification Request (or CR/AAR).