Introduction

After you have submitted a Main REB Application Form (or Statement of Intent), or an amendment to a previously approved REB application, the Research Ethics Office will conduct a preliminary review prior to forwarding (if required) to the REB for further review and approval. During these review cycles, there may be requests to clarify or modify your content.  

Applicants receive a summary of the comments and requested modifications and will be required to address the feedback, re-upload any supporting documents (and delete ones that are no longer valid) and resubmit your application.  

If you have any questions as you respond to feedback requests, please reach out to RAIMSsupport@uoguelph.ca who will promptly address or triage your question.  

You can also use the Correspondence feature in your application to email the Research Ethics office if your question is more ethics-related (e.g. you are looking for ethics guidance specific to the scope of your research study).  

Email Notification and Modification Statuses

If modifications are requested, the applicant (or anyone on the study team configured to receive notifications) receives an email notification with an attached Feedback Letter (PDF) summarizing the feedback and requested revisions. As you address the feedback and resubmit the application, the status of the application will update accordingly.  

Sample Email  

The email will include the Project ID reference and the Feedback Letter as a PDF attachment.  

Screen shot of a sample email notification when an application is ready for review.

Sample Feedback Letter

The Feedback Letter summarizes feedback in a table so you know each question for which feedback or modifications will be needed.  

Download the Feedback Letter (or print, if desired) so you have it as an ongoing reference as you address the changes.  

You will be able to link directly to your project from the Feedback Letter.

Screen shot of a sample Feedback Letter with a table that shows the EthOS area and the comments from the REB.

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Modifications Requested Statuses

Modifications can be requested during an initial submission or an amendment. They can also be requested from the Research Ethics Office before the REB review (as part of the Pre-Review for Clarification), or from the REB after their review. As your application moves through the modifications workflow, and depending on your scenario, you may see one of the following statuses for your project. (For a full list of statuses, consult the Status Definitions table in the Basic Navigation user materials.)

Status When
Modifications Requested (Pre-Review) The Research Ethics Office is requesting clarification to a main form application before sending to the REB
Modifications Received (Pre-Review) You have submitted your main form pre-review modifications back to the Research Ethics Office
Modifications Request The REB has requested clarification of your main form application
Modifications Received You have submitted your main form modifications in response to REB feedback
Modifications Request SOI The Research Ethics Office is requesting modifications to your Statement of Intent (SOIs do not require further REB review)
Modifications Received SOI You have submitted your SOI modifications back to the Research Ethics Office
AMD Modifications Request (Pre-Review) The Research Ethics Office is requesting clarification to an amendment before sending to the REB
AMD Modifications Received (Pre-Review) You have submitted your amendment pre-review modifications back to the Research Ethics Office
AMD Modifications Request The REB has requested clarification of your amendment
AMD Modifications Received You have submitted your amendment modifications in response to REB feedback

 

To see your application’s status:

  1. Use the link in the Feedback Letter or log into EthOS and find your Project in the Project List (search by Project #)

  2. Expand the Project title and note the status

    Screen shot of a the Project search bar, the Project Title drop-down arrow and the status of a project highlighted.

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Addressing Feedback – Process Overview

After you have reviewed your Feedback Letter, preparing and submitting your response will involve the following:  

  1. Navigate to your project (from the Feedback Letter or search by Project ID in your Project List)  
  2. In the Application Overview, you will indicate that you are providing a Response to REB Feedback
  3. After which, the form will open a Resubmission Details panel at the end of each section for you to summarize any changes made in that section (referencing the related REB comment)  
  4. Documents that are nullified as a result of the feedback are to be deleted and new, clean versions of those documents should be uploaded in their related question area; tracked changes versions of certain documents will also be required as part of the final resubmission summary section at the end of the form  
  5. At the end of the form, you complete the Resubmission Information section to summarize your feedback (including why you may have opted not to address any feedback items) and upload any additional or tracked changes documents  
  6. Prior to resubmitting, you can leverage the EthOS Tracked Changes feature which allows you to compare your current and previous versions of your content – extremely useful!  
  7. The Principal Investigator (PI) will need to sign the resubmission  
  8. Upon resubmission, you receive a confirmation email and the workflow continues through the remaining review and approval cycle  

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Preparing your Feedback in EthOS

Once you have reviewed your Feedback Letter, you can prepare your response. Consider having your Feedback Letter open and/or printed to ensure that you are addressing all items.  

  1. Open your project from the Feedback Letter link or log into EthOS and find your Project in the Project List (search by Project #)  

  2. Open the Application Overview section  

    Screen shot of the Main REB Application Form with the Application Overview section and question highlighted.

  3. Indicate that you are providing a Response to REB Feedback (note how the process for responding to REB feedback is summarized here also for you)  

    Screen shot of the Main REB Application Form with the response to REB Feedback option selected and highlighted.

  4. The Response to REB feedback selection will result in a Resubmission Details panel being visible at the end of each section in the form  

    • Note: there is also a mandatory Resubmission Information section at the end of the application which will be explained later in these user steps

      Example of a Resubmission Details panel

      Screen shot of the Resubmission Details panel that appears at the bottom of each page (this example is for Informed Consent).

  5. Navigate through the application, summarizing how you have addressed each feedback item in the Resubmission Details panel in each section

  6. In the Actions pane, you can also use the Reviewer Comments tile which summarizes the list of comments from the reviewers and allows you to navigate to the related question  

    Screen shot of the Reviewer Comments button in the actions pane highlighted with the number of comments showing one.

    • Note: you can also access comments about each question from the comment ‘bubble’ icons to the right of each question; the first of which shows the number of comments from the study team (only visible to the study team), and the second shows the number of comments made by the reviewer(s)

      Screen shot of an Ethos question and two comment icons showing that there have been comments made on the question.

  7. As you address the feedback in each section, please delete any documents that are no longer valid and re-upload clean, new versions in that section so that your resubmission includes only the latest versions of the documents; for more information see Deleting and Uploading Documents section below.  
    • Note: you may also need to upload tracked changes versions of documents, but you will do so in the final Resubmission Information section at the end (see Steps 8 and 9)  
  8. At the end of the application you reach the Resubmission Information summary section; identify if any documents were changed as a result of the REB’s feedback and upload the tracked changes version here  

    • Note: the clean (accepted changes) version should have been uploaded already in its related question area (see Step 7 above), but if not then please return to the relevant section to do so  

      Screen shot of the Resubmission Details list that appears at the end of the response to REB feedback form.

  9. If you have any further documents that have not yet been uploaded as part of your response, select Yes and follow the upload prompts; otherwise, select No

    Screen shot of the Do you Have other documents question and the Yes and No options.

  10. Enter any final or further comments in response to the feedback, considering the guidelines provided

    Screen shot of the last section on the response form asking for any additional information and the text box where you enter it.

  11. Prior to requesting the PI’s signature (or signing, if you are the PI), you may wish to review the changes you have made compared to your previous submission; see the Comparing to a Previous Version user materials
  12. When you are ready to resubmit your application having addressed all feedback and document requirements, the remaining steps are the same as new submissions: the form will need to be resigned by the Principal Investigator as per the steps in Signatures and Submitting Applications

  13. Once the PI has re-signed the form, the Signatures tab is updated, the form owner receives an email confirmation, and the status of the submission changes to one of the Modifications Received statuses depending on your scenario

    Screen shot of a Project with the status highlighted showing Modifications Requested (Pre-Review) status.

You have now completed your response to REB Feedback. See below for some EthOS functionality you may have needed to use throughout these steps.  

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Deleting or Uploading Documents

Many feedback requests involve a change to the previously submitted study documents. For example, you might be requested to upload a new document or edit one that was previously submitted.  

Whatever documents you originally attached to the application will be visible and downloadable as you complete your resubmission. If you delete a document as part of the resubmission, it is removed from the application form only, not your hard drive.  

Note: When you are changing documents (deleting, replacing, or adding new ones), you cannot do so from the application’s Documents tab. Instead, you must navigate to the form’s section and the specific question prompt for which the document was originally uploaded and delete (and/or re-upload) from there.  

Because this feature is similar across many EthOS application scenarios, please see the Deleting or Uploading Documents steps in the Amendments user materials.    

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Comparing to a Previous Version

As you are making your changes, and before you submit them, you may wish to remind yourself or confirm what you have changed since the previous version.  

Note: This feature allows comparison between previous and current versions on the form responses. If you change documents, EthOS will highlight the addition (or deletion) as a change in the list of attachments, but does not highlight changes in the contents of each document. If you need to compare document contents (e.g., differences between two survey questionnaires) please do so outside of EthOS.  

Because this feature is similar across many EthOS application scenarios, please see the Comparing to a Previous Version steps in the Amendments user materials.

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