Amendments

Introduction

Once your Main REB Application Form or Statement of Intent (SOI) is approved, you may need to submit an amendment when there is a change to the approved protocol that affects participants at any stage of the research including, but not limited to, changes to the consent form, the addition of study interventions, or changes to measures to protect privacy and confidentiality.

If you are unsure of whether an amendment is required for your research protocol, contact reb@uoguelph.ca for help and guidance.

Note: The steps below are for EthOS-generated Main REB Application Forms or SOIs. If you need to amend a protocol that resides in your project list as a Legacy Protocol (approved prior to the EthOS launch using the MS Word form), please consult the Legacy Protocol user materials.

Process Overview

To amend an approved Main REB Application Form or SOI, you will first outline a summary of the changes required to the REB, and then ‘unlock’ your form to make those changes.

You will then sign the amended application as the Principal Investigator (PI), or request their signature if you are not the PI completing the amendment, which will trigger the amended application to be submitted for REB review and approval.

As with initial submissions, the amendment application is subject to any modification requests after REB review, prior to approval.

Once approved, a new approval certificate is issued for the protocol.

Applicants receive automated notifications from EthOS as the amendment moves through this workflow.

• Reminder: Notifications are sent to your EthOS email address and also appear in your Work Area Notifications tile. 

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Unlock your Previously Approved Application

1. From your EthOS Work Area and Project List, locate the project to be amended

2. In the Actions pane on the left of the screen, click on the Unlock to Amend button (only available for previously approved submissions) 
   
    

   An Unlock to Amend pop-up window opens for you to enter summary details about the amendment including the current status of the application, the scope of your changes, and the rationale. Once this pop-up window is open, scroll through and answer the question.

   Important: If you close this pop-up window - either by clicking the X, the Close button, or EthOS times out - you will lose any of your answers! Plan to answer these questions in one sitting.

3. If there is an asterisk beside the Timeline Notes field, enter some content (e.g., today’s date, or your project’s title); otherwise ignore this field and continue scrolling through the form answering the prompts

   

4. When you have finished scrolling through and answering the questions, click on the Preview button to generate a PDF view of your responses

   

   • We strongly suggest that you download or print the PDF version to cross-reference with the changes you will soon make in the application itself

5. When you are happy with your answers, click on the green Unlock to Amend button, and then answer Yes to confirm

   

6. The status of your application will change to Under Amendment (visible from the main page of the application underneath the Project Tree area)

   

   You are now ready to update your previously approved application with your desired amendments. 

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Make Your Amendments

Once the form is unlocked, you can proceed with making your desired changes directly in the previous application.

Note: To reduce the need for clarification or modification requests before or during the review of your amended protocol, ensure that whatever changes you outlined in the Unlock to Amend step are now reflected in the amended application. This includes the deletion or replacement of any previous study documents that are no longer valid or have changed. Referencing the PDF of your initial answers is a great way to ensure that you are making all the changes you indicated were required.

1. From the Application Overview screen, select Initial Submission (an unlocked form is considered an initial submission)

   

2. Continue working your way through the unlocked application, updating the content as required

   • Reminder: You can use the Navigate button to jump to specific sections of the form, or use the Previous and Next buttons to move through your application page by page

     

   Since amending an application has unlocked the form, the functions available to you are the same as those during the initial application. See the user materials under Create & Submit an REB Application for a reminder on any of these steps. 

   However, there are some EthOS features that you will likely want to use when you are amending a previous application, as per below.

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Deleting and Uploading Documents

Many amended protocols involve a change to the previously submitted study documents. For example, if you are adding a new survey then you should upload the new survey questionnaire.

Whatever documents you attached to the original application will be visible and downloadable from the Documents tab or their related section/question area. If you delete a document, it is removed from the application form only, not your hard drive.  

However, when you are deleting, replacing, or adding new documents, 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.

To delete a document:

1. Navigate to the section and the question where the document resides

2. From the document area, locate the document and click on the Delete button

   

   The document is deleted from the application.

To add a new document:

1. Navigate to the section and question prompt to which the document will apply

2. Click on the Upload button

   

3. Click on the Browse button to select the file from your computer’s local or network drives, enter the Version Date and Version Number and click on the green Upload button

   

4. EthOS displays a green Save Complete banner to confirm that the document was added.

Note: To upload multiple documents, repeat steps 1-3. To replace a document, first delete the document that is no longer required and then add the new or updated one.

The following short clip shows a user first deleting a document and then replacing it with a new one.  

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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. EthOS allows you to see the changes between your previous and current versions.

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.

To compare versions:

1. From any page in your application, if changes have been made you can click on the Compare with Previous Version button in the top right corner of the section

   

2. EthOS displays a panel on the right-hand side of your screen in Track Changes mode
3. On the page, review the changes:
   • Content that has been added is highlighted in green
   • Content that has been changed is highlighted in red
   • Content that has been deleted is highlighted in red and shown in strikethrough font

4. To turn off the Track Changes mode, click on the Return to Edit mode and continue making your changes

   

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Review Your Amended Application Before You Submit

We encourage researchers to review your amended application before triggering the final Signature step. Ensure that you have addressed all the changes you outlined in the initial Unlock to Amend form.

Tip: This will be easier if you have printed or downloaded a PDF version as per the suggestion in the earlier Unlock to Amend steps.

1. From any page in the application, click on the Navigate button to return to the Main Application Overview page; here you can spot-check areas as needed, e.g.:
   • Review the Documents tab to ensure that you have successfully uploaded (or deleted) any changed documentation
   • Review the Collaborators tab to confirm that your study personnel are correct and have the correct permissions
   • Review the Correspondence tab to review and previous correspondence with the Research Ethics Office, or to send a new email to the Research Ethics Office

2. When you are ready to Sign (or Request a Signature), navigate to the Signatures section

   

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Sign and Submit an Amended Application

When you have made and reviewed all your desired changes, the PI (if not yourself) will need to sign your amended application before it can be submitted.

These steps are the same as with your Main REB Application Form or SOI submission. See the instructions under the Create & Submit an REB Application, Signatures & Submitting Applications.

Note: On the Main REB Application Form page, the form’s status will appear as Under Amendment until the PI’s signature triggers the automatic submission to the REB office. Once submitted, you will receive an automated email and notification and the form’s status changes to Amendment Submitted.

You have now completed your amendment.

As with the initial submission, the Research Ethics Office may request clarification or modifications during either the pre-review clarification or review of your amendment. See the user materials under Responding to REB Feedback for guidance on these steps.

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