This QuickGuide outlines steps for viewing and responding to comments from the REB within MacREM.

*NOTE: There may be recommendations for changes by the Ethics Office and by the MREB Chair. The Ethics Office will ask for recommendations for example if your application is not complete when submitted. The MREB Chair will ask for changes based on the review outcome from reviewers on the board.  The process for responding to these comments differ; please see below.

Viewing REB recommendations

There are multiple ways the view the recommendations:

1. Email:
   • When recommendations are ready, you will receive an email containing a PDF letter with the recommendations, and a link to your project.
   • Clicking this link will take you right to your project (if you are logged in) or the login page (if you are not logged in)
2. MacREM Notification Tile
   • At the same time as the email is sent, a Notification will be placed in your Notification Tile.  You will see that the number of Notification has increased, and the numbers will be red.
   • Clicking on the Notification tile will bring you to Notifications page, and you’ll see a new one: “Notification received: Application returned to Applicant”.  You can navigate to the form from that page.
3. History Tab
   • When inside the relevant project, you will see a “history” tab on the main page
   • Clicking all that tab will show every notification in the project’s history, and you can also download all the letters sent by MREB about the project.
4. Reviewer Comments Tile
   • When inside the relevant project, you will see a “Reviewer Comments” tile on the left.  Clicking that tile will show you the current comments, and you can click on the comment to be brought right to the relevant question.

• If you open the application and click on the review comments you can go directly to the panel where the comment was made. Alternatively you can navigate through the application to find the number in a blue bubble on the panel where the comment was made.
•  Some of the changes that you will be requested to make are specific changes requested while others are more like responding to comments or concerns.

Responding to MREB Comments

NOTE: You could SHARE your application with the Ethics Office (with their permission) if you would like some initial consultation on the completeness of your application. Please contact the ethics office at ethicsoffice@mcmaster.ca or ext. 23142 for more information. The Ethics staff can also remotely connect with your application to walk you through the process.

1. Question 1.4 asks if you are creating an Initial Submission or Responding to MREB Recommendations.  You will want to be sure that the proper response is chosen.
   • “My new application OR my revised application in response to the Research Ethics Officer’s administrative comments” does not require a response document
   • “My revised application in response to ethics review comments from the MREB Chair” will open up Question 1.5, where you need to upload a response document.  Please see Point 4 below for more information.
2. Navigate to applicable questions within the online form and make the revisions.  Edits to text fields in the main form should be made within the online interface so the system can track the changes (as opposed to making changes in a Word document and then pasting back into MacREM).
3. Revise Supporting Documents if Required (e.g. Letter of Information, Questionnaire, etc.)
   • Use grey highlighting or track changes so the Chair can easily see revisions.
   • Upload a PDF version of the revised document(s), with a new version number, to the appropriate question within the application.
   • Delete the old version of the document(s) from the application.
4. If applicable, summarize the Revisions for the Chair
   • Create a document that lists each reviewer comment (and question number), along with your response to the comment. Follow the format in the Sample Summary of Revisions document.
   • Use italics, or some other visible formatting, to distinguish your response from the reviewer comments.
   • Any changes you make to the application that are in addition to responding to reviewer comments should be explained in the document as well.
   • Upload the summary of revisions document in Question 1.5. The attachment should be in PDF format.

Following the above steps will make it easier, and therefore faster, for the Chair to review the revisions. If you think it will be insufficient to use the summary document to address a concern you have with a specific reviewer comment, and that a discussion with the Chair may be necessary, please directly contact the reviewing Chair via email or phone.

*** Once everything is done you can sign the form to resubmit to the Chair. The Chair will be notified when you have responded or made revisions.

Receiving Clearance

• If your response is satisfactory, you will receive an email and letter of clearance which means you can start your research. The “official” letter of clearance will arrive later sent by the Ethics Office, once they have set an expiry date for annual reporting purposes. Both documents will be saved in your project.
• If your response still requires more clarification, the Chair will return it to you again with additional comments. You will need to follow the “Responding to MREB Comments” steps again and resubmit.

Questions?
T. 905-525-9140 ext. 23142
E. ethicsoffice@mcmaster.ca

If you wish to download a PDF copy of this document, please click here.