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How Do I Respond to an REB Request for Clarifications?

How Do I Respond to an REB Request for Clarifications?

If the Research Ethics Board (REB) requests clarifications about your application, the Principal Investigator (PI) and student lead (where applicable) will be notified via email. The email will include a Word document outlining the questions for clarification from the REB. You will need to save this document to your computer and then type your responses to the questions in the document (as noted in the email). Once finished, you will use the Attachments tab to attach the ‘Clarifications Required’ document to your application in IRIS.

Clarification Response for New Applications:

  1. When clarifications are requested, edit access will be granted to your research team for the application. You will find the application in the Applications: Requiring Attention link on the home page in IRIS. Remember, this link may be found under either the Role: Principal Investigator section or Role: Project Team Member section, depending on your role as noted in the file.
  2. After editing the application and attaching the Word document with your response to clarifications, the PI can resubmit the application. While all project team members can view and edit the application, only the PI is able to submit.

Clarification Response for Post Approval Applications (eg. Change Request, Renewal, Closure, Adverse Event):

  1. Under Role: Principal Investigator, click on ‘Events: Requiring Attention’. In the next window, select the ‘Events’ button.
    1. Scroll down to the ‘Events: Requiring Attention” section, and select the ‘Edit’ button.
  2. Clicking 'Edit' allows you access to the original project application. Make any changes that were requested in the ‘Clarifications Required’ letter.
  3. Upload the clarification response letter using the Attachments tab.
  4. When all revisions to the Change Request Application have been made and the clarification response letter is uploaded to the Attachment tab, click ‘Re-Submit’ to send your application back to the REB. 
  5. Please note that ‘Save’ will only keep your application in IRIS and will not send it back to the REB.  You need to click ‘Re-Submit’ to send it back to REB.

Notes:

  1. Applications with student leads or postdoctoral leads will require review and approval from their supervisor before resubmitting. While the student lead can make the edits and attach the response to the clarifications document, only the supervisor (who will be noted as the PI on the application) can resubmit the application.
  2. You will no longer have access to edit the application after it is resubmitted. If you need to make further edits to the application, you will need to contact the research ethics coordinator to return your application to you (see the IRIS support page for contact information).  This will delay the review of your application.