IRB Review Types

Research that involves no more than minimal risk and meets criteria specified by federal regulations may qualify for exemption.

Note: Effective June 21, 2017, new Exemption Applications must be submitted via the new web-based application system "E-IRB". You are NOT required to submit a paper copy when submitting through the E-IRB system. Visit the E-IRB information web page for more info, E-IRB Log-in, and the link to video tutorials.

• Exemption Certification Request (application) (Log in to E-IRB)
• Limited Review Form for Exempt Categories (Required for Exemption categories 2 & 3 if retaining identifiers)
• Issues to be Addressed When Conducting Exempt Review (This document helps explain the exemption categories and the issues that IRB reviewers must address when making a determination about Exemption Certification)
• Exempt Review SOP
• UK ORI New Common Rule Exemption Categories Tool
• Exempt Review Decision Interactive Tool
• UK ORI Exemption Decision Charts

***Modifications for Exempt protocols that were submitted and approved via IRBSubmission@uky.edu will still be submitted electronically in PDF format to IRBSubmission@uky.edu. If an Exempt protocol was submitted via E-IRB, the modification must be submitted through E-IRB.***

The Institutional Review Board (IRB) uses an expedited review process to review studies that meet the categories adopted by the Department of Health and Human Services (DHHS), or the Food and Drug Administration (FDA) and that involve no greater than “minimal risk.” Expedited review procedures allow the IRB to review and approve studies that meet the criteria in the attached document without convening a meeting of the full IRB.

Contact: For both Medical and Nonmedical Initial Expedited Review, contact ORI at (859) 257-9428 or IRBSubmission@uky.edu, to be forwarded to the appropriate ORI staff person. 

• Medical & Nonmedical Expedited Review Applications (Log in to E-IRB)
• Issues to be Addressed When Conducting Expedited Review (This document helps explain categories and the issues that IRB reviewers must address when making a determination about the research's eligibility for expedited review.)
• Expedited Review SOP 

Research that cannot meet the criteria for exempt or expedited review must be submitted for full review.

• Medical Full Review Application (Log in to E-IRB)
  • See our Contact Us page for Medical IRB staff contacts
• Nonmedical Full Review Application (Log in to E-IRB)
  • See our Contact Us page for Nonmedical IRB staff contacts
• Full Review SOP (Revised 7/8/11)
• Requested Revisions from a Full Review - Major versus Minor Determination: "Guidance on whether convened IRB request should be designated as minor (vote #2) or major (vote #3 or #4)"
• Criteria for IRB Approval: Reviewer Checklist [F26.0000]

A modification is defined as any change to a protocol from what was previously approved during the period for which approval was given. Changes in research procedures, study personnel, the informed consent process, and/or the consent/assent document cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.  Should protocol changes be made without prior IRB approval to eliminate apparent hazards to the subject(s), submit a memorandum immediately to the IRB addressing the nature of the change, why it was necessary, and the outcome.  

Click here for more information. 

Federal regulations dictate that previously approved research protocols must be re-reviewed by the respective IRB at least once a year. 

Click here for more information.

Deviations and Exceptions - IRB Review of Changes SOP (3/15/19)

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.  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.

Protocol Violation Review SOP (Revised 8/19/09)

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.

Unanticipated/Anticipated Problem/Adverse Event Reporting SOP (Revised 7/8/11)

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

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

Forms:

• Internal Prompt Reporting Form
• External Prompt Reporting Form
• Non-Prompt Reporting of Problems/Events (If sponsor requires the PI to submit reports that do not require reporting according to UK's policy)

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).