Responding to IRB Request for Clarification, Modifications Required to Secure Approval, or Deferral

You may receive a request from IRB to make changes to your submission during the pre-review screening process or after formal IRB review. Three different scenarios require the study team to respond to move the review forward.
•    Clarification Requested
•    Modifications Required to Secure Approval (MRTSA)
•    Deferral- Full Board Studies Only

The PI, PI Proxies, and the study’s Primary Contact will receive an email notification that the IRB has requested a response from the study team. Log into Research Gateway IRB (ReGI) to view the IRB’s requests.

How to Respond

Review the Respond to IRB Requests user guide for step-by-step instructions on how to: 

  • Locate the IRB's requests
  • Prepare a written response
  • Edit the study documents and SmartForms
  • Submit your response

Clarifications Requested

“Clarifications Requested” is the process by which an IRB Coordinator sends a request for clarification or study changes during the pre-review screening phase. Your response will be reviewed by the IRB Coordinator, who will then:
•    Return it with more clarification requests, or
•    Move the submission forward for formal review

Modifications Required to Secure Approval 


“Modifications Required to Secure Approval” is a formal review outcome. It means that the submission can be approved after specific modifications are made by the study team. Once the modifications are made, the approval becomes effective. Your response will be reviewed by the IRB Coordinator, who will then:

  • Return it if not all modifications were addressed sufficiently, or
  • Send it to one or more IRB Reviewers for review, or
  • Approve the submission. 
  • In iRIS, this outcome was called “Revisions required.

Deferral

“Deferral” is a formal review outcome. It means that the IRB requires additional review they can determine if it is approvable. Your response will be reviewed by the IRB Coordinator, who will then:

  • Return it if not all requests were addressed sufficiently, or
  • Place it on an upcoming agenda for a fully convened IRB meeting.
  • In iRIS, this outcome was called “Return for additional information.”
     

Tips for Responding to the IRB

  1. Address each request in writing in a point-by-point format.
  2. Provide rationale if you disagree with the request.
    If you disagree with the IRB’s recommendations and do not wish to make a certain change, provide rationale for not making the change. Without an explanation, the response will not be complete and approval may be delayed.
  3. Revise your study materials
    If you need to revise any portion of your study or submit new documents, follow the instructions in the user guide. 
    When revising Word documents, make sure Tracked Changes in ON. Submit the version with Tracked Changes to the IRB. During approval, the tracking will be accepted, and a clean final document will be created.
  4. Make general comments about the response (optional). If you have any general comments to submit with your response, include them in the "Notes" section when submitting the response (see the user guide).
     

If you need additional help or have questions about the stipulations, contact the IRB analyst assigned to the submission.

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