Frequently Asked Questions (FAQs)

Any activity that meets the federal definition of both "Research" and "Human Subjects" or the Food and Drug Administration (FDA) definition of "Clinical Investigation" requires review and approval by the University of Kentucky (UK) IRB. Additional information on this topic is available at the What Needs IRB Review webpage and in ORI's Guidance/Policy Document: When do activities involving human subjects need Institutional Review Board (IRB) review and approval? (PDF).

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Full reviews generally take longer to approve because the IRB must conduct the initial review (and sometimes subsequent reviews) at a convened meeting. A typical turnaround time for full review submissions includes:

• Protocol Submission: When an investigator submits a full review protocol, the E-IRB system schedules the application on the agenda for the next available IRB meeting. Medical IRBs meet every three weeks, and the Nonmedical IRB meets once a month. Protocols are scheduled “first-come, first-served” with a limited number of full reviews allocated per IRB meeting to ensure adequate time for discussion and deliberation.
• Initial IRB full review: IRB members receive the agenda for a convened meeting 7 working days in advance. Determinations for scheduled protocol reviews are made during the convened meeting.
• If the IRB committee requests revisions, ORI staff can take up to 3 working days to convey the IRB’s request. If the protocol is approved during the initial convened meeting, ORI staff may take up to 2 working days to communicate the determination.
• Additional IRB full review: If the IRB makes a ruling of minor revisions (directive or non-substantive changes), the IRB Chair is given the authority to approve the revisions through an expedited review procedure when they are submitted. In this instance, ORI staff can take up to 3 working days to screen revisions after the protocol has been resubmitted. The Chair that is reviewing the revisions can then take 10 working days to complete the review.
  
  If the IRB requests major (substantive) clarification or revisions, the revisions cannot be approved through the expedited review procedure (i.e., only by the IRB Chair). An entire convened board will review the major revisions at the next available convened meeting. In this instance, the revisions should be submitted before the close of the meeting agenda.

Factors That Can Impact the Review and Approval Process

• Screening and reviewing timelines are working days and do not include weekends or holidays.
• The amount of time it takes an investigator to respond to a request for revisions from the IRB reviewer. The longer the investigator needs or takes to resubmit the application, the longer the overall review and approval time.
• An IRB-requested consultant review of the application (e.g., due to subject population and/or non-English consent documents).
• Limited ORI staff or high volumes of protocol application submissions.

Generally, IRB approval can take between 4-6 weeks. However, not all submissions will take that long, and some approvals may take longer. General turnaround for an exempt or an expedited approval includes:

• Initial Screening: Once a protocol application is submitted, ORI staff may take up to 3 working days to either contact the investigator for further information or send for IRB review. This is the same for Initial Reviews (IR), Modification Requests (MR), Annual Administrative Reviews (AAR), Continuation Reviews (CR), or Other Reviews (OR).
• Additional Screening: If a protocol application is returned to the investigator with screening comments from ORI staff or request for revisions from the IRB reviewer, ORI staff may take up to 3 working days for an additional screening after the protocol is resubmitted by the investigator.
• Initial IRB review: Once a protocol application has been assigned an IRB reviewer, the IRB reviewer is asked to complete their review for an IR, MR, AAR/CR, or an OR within 10 working days.
• Additional IRB review: If the IRB reviewer requests revisions be made to the protocol application, ORI staff may take up to 3 working days to communicate the IRB request for revisions to the investigator. When the investigator resubmits the revised protocol application, the IRB reviewer is asked to complete review of the revisions within 10 working days.

Factors That Can Impact the Review and Approval Process

• Screening and reviewing timelines are working days and do not include weekends or holidays.
• The amount of time it takes an investigator to respond to screening comments from ORI staff or request for revisions from the IRB. The longer the investigator needs or takes to resubmit the application, the longer the overall review and approval time.
• An IRB-requested consultant review of the application (e.g., due to subject population and/or non-English consent documents).
• Limited ORI staff or high volumes of protocol application submissions.
• IRB reviewers who volunteer their time can sometimes experience unforeseen circumstances that require reassigning the protocol to another reviewer.
• The IRB reviewer determines that the protocol needs to go before a convened board.

For IRB determination issues, contact the applicable IRB Committee. Go to the ORI Staff web page to contact a specific staff member or submit feedback anonymously on our customer service form. If the issue is regarding ORI or administrative procedures, contact ORI Director, Dr. Helene Lake-Bullock.

You can also request a consultation if you aren’t sure who to ask. Consultations are offered for studies in development as well as approved research projects. Provide the E-IRB protocol number for approved or submitted studies.

Submit a request for a consultation

We host Office Hours events as well, for your convenience. You’re welcome to drop in with any questions about current research, developing projects, the E-IRB system, and more! A variety of staff will be available to answer questions and provide support in real time. 

View upcoming dates for ORI Office Hours