IRB Review Types

IRB Introduction [PDF]

Exemption

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.

Contact: Joe Brown, 859-257-9084

  • Exemption Certification Request (application) (Log in to E-IRB)
  • Issues to be Addressed When Conducting Exempt Review [PDF] (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 [PDF]
  • UK ORI New Common Rule Exemption Categories Tool [PDF]

***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. Please contact Joe Brown (Joe.Brown@uky.edu) or Craig Vaughn (CraigVaughn@uky.edu) for any additional information.***

Initial Expedited Review

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 [PDF] (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 [PDF]

Initial Full Review

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)
  • Nonmedical Full Review Application (Log in to E-IRB)
  • Full Review SOP (Revised 7/8/11) [PDF]
  • 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)" [PDF]
  • Criteria for IRB Approval: Reviewer Checklist [F26.0000] [PDF]

Modification of a Currently Approved Protocol

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, 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. 

Continuation Review

Federal regulations dictate that previously approved research protocols must be re-reviewed by the respective IRB at least once a year. Continuation review by the IRB requires the investigator to complete and return a report form sent to him/her by the Office of Research Integrity.

If you need a CR report form for your study, please contact the Office of Research Integrity and provide the IRB protocol number. A CR report form specific to your study will then be generated and sent to you.

Click here for more information.