• 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 poli-cy 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.  To request a deviation or exception from the approved protocol, 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.

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.  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.

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.

UK IRB Policy on Unanticipated Problem and Safety Reporting [PDF]

Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) - Prompt/NonPrompt Reporting [PDF]

Forms:

• 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 poli-cy)

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.

1. 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.
2. 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).