Renewals, Closures, Event Reports

Introduction

Post-approval activities will be required at some point during your project's life cycle. While there are a variety of scenarios that warrant a post-approval submission, all of them will involve the use of an EthOS subform. Subforms are ‘branches’ (children) of the Main REB Application or SOI form (parent), and are part of the overall Project in EthOS. As you create subforms, the Project Tree hierarchy grows, with every subform branching off its parent application form.  

If you are unsure of how any of these scenarios apply to your research protocol, contact reb@uoguelph.ca for help and guidance.  

The steps below are for EthOS-generated Main REB Application Forms or SOIs. If you need to renew, close, or report on a protocol that was approved using the pre-EthOS MS Word forms, consult the Legacy Protocols user materials. (Although the system steps are similar, training materials on pre-EthOS content are consolidated for you in the Legacy Protocol user material section).

Post-Approval Activity for Main REB Applications

Once your Main REB Application is approved, at some point you will need to complete one or more of the following actions:

• An annual renewal if the study is continuing beyond its current expiry date to ensure that your protocol has continued ethics approval
• A study closure when the research is considered complete, all data has been collected, and no further study activities will be taking place
• An event report when any unanticipated issue or event has occurred that has impacted, or could impact, the protection of the human participants involved in the study

Note: 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, you will need to amend the previously approved protocol. Consult the Amendments user materials.

Post-Approval Activity for Statements of Intent (SOIs)

When an SOI is created, the applicant enters the date on which they expect (or will need) their subsequent REB ethics application to be approved. Since this date is often an estimate and needs to take into account time required to prepare an ethics application and the REB's review times, it is possible that the timeline is missed. When this happens, the SOI date must be extended. Without an extension, the Research Ethics Office will notify the Grant Teams (Research Support Services, Agri-Food Partnership Office, etc.) of the SOI expiry, which could potentially risk the research team's access to their funding accounts.

Alternatively, once an REB ethics application is approved, the researcher must officially close out the SOI as part of the grants and funding process.  

For either of these scenarios, researchers should complete an SOI Renewal/Closure form, the steps for which are also included in these materials.

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Process Overview

Renewals, Study Closures, and Event Report subforms in EthOS can only be added to approved projects.  

To confirm if your project is approved, locate the project in your EthOS Project List and review the status information under the Project Tree.  

Once created, subforms will be part of your overall Project file’s hierarchy and will extend from the Main REB Application (or SOI) branch. Key details from the initial main application are inherited and ‘shared down’ to the subforms.  

• Tip: When you are completing your main application, every time you see a red sideways “V” beside a question area, this lets you know that whatever you are entering in that section will be inherited by any subforms.

  

As with main forms, subforms can be shared with other study members. The Principal Investigator’s (PI’s) signature will also be required, and the form is automatically submitted after the signature is received.  

All three of the renewal, closure, and event report subforms are very short and follow the same system steps. They are reviewed and approved by the Research Ethics Office and/or the REB where required. As with other applications, there may be a request for clarification or modifications prior to approval.  

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Expiry Date Automated Alerts - Main REB Applications

EthOS will trigger an automated reminder alerts starting 4 weeks before the expiry date on the currently approved study. Please ensure that you renew (or close) your protocol prior to expiry to remain in compliance with the Tri-Council Policy Statement.

If you have missed renewing the application, EthOS will trigger a reminder alert 2 weeks after the expiry date. Again, please prioritize your prompt attention to either renewing or closing the protocol as soon as any alerts are received.

The Research Ethics office is here for any support you need so that your study is renewed proactively and avoids any compliance issues.

Note: The Research Ethics Office no longer requires the 5 year resubmission process for approved protocols. You can continue to renew studies annually for as long as necessary.

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Expiry Date Automated Alerts – Statements of Intent

EthOS will trigger automated reminders starting 2 weeks before an SOI’s expiry date and will continue after an SOI has expired.  

Non-compliant, expired SOIs could impact the researcher's access to funding, so it is imperative that SOIs are renewed (or closed, if applicable) asap upon receiving any automated reminder. As with all applications, the Research Ethics Office is here for any support you need so that your SOI is renewed (or closed) in a timely manner.

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Main REB Application Renewals, Event Reports, or Study Closures

The EthOS steps for submitting a renewal, event report, or closure are the same regardless of the type of subform you are creating.  

1. In your Work Area’s Project List, locate the project for which you will create the Annual Renewal, Event report, or Closure

2. In the Project Tree, make sure you are on the ‘parent’ submission for which the subform will be created, and then in the Actions pane on the left-hand side of your screen, click on the Create Subform button (only available on approved applications)  

   

3. From the drop-down list, select either Annual Renewal, Event Report, or Study Closure and then click on the green Create button  

   

4. EthOS displays a green banner indicating that the subform was created successfully  

   

5. In the Project Tree, your subform has been added as a new ‘branch’ below the main application form

   

6. From your subform, navigate to the first page of questions (you will need to scroll down to find the editable portion)
7. Complete the required questions and upload any required documents
8. Complete the signature step  
   • Note: The Signature (or Request Signature) steps for a subform are the same as the main application process; consult the Signatures and Submitting Applications user materials  

Once the signature step is complete, the subform is submitted to the Research Ethics Office and routed for their review and approval. You will continue to receive automated email notifications throughout the approval cycle.  

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Statement of Intent Renewal/Closure  

1. In your Work Area’s Project List, locate the project for which you will create the SOI Renewal/Closure subform  

2. In the Project Tree, make sure you are on the ‘parent’ SOI for which the subform will be created, and click on the Create Subform button (only available on approved SOIs)  

   

3. From the drop-down list, select SOI Renewal/Closure and then click on the green Create button  

   

4. EthOS displays a green banner indicating that the subform was created successfully  

   

5. In the Project Tree, your renewal/closure is added as a new ‘branch’ below the SOI form; click on the first page of Questions (SOI Renewal/Closure)

   

6. From your subform, navigate to the first page of questions (you will need to scroll down to find the editable portion)
7. Complete the required questions, continuing to follow the instructions in the form
8. Complete the signature step  
   • Note: The Signature (or Request Signature) steps for a subform are the same as the main application process; consult the Signatures and Submitting Applications user materials  

Once the signature step is complete, the subform is submitted to the Research Ethics Office for review. Once approved, the Grants Team (Research Support Services or Agri-Food Alliance office) will be notified so they can proceed with the release of funds. You will continue to receive automated email notifications throughout the approval cycle and the Grants Team will also be notified of any SOI expiries, renewals or closures for your project(s).

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Modifications Requested on a Subform

For any of these subforms, if clarifications are needed the application will be returned to you in a Modifications Requested status. You will be required to resubmit and can follow the steps in Responding to REB Feedback user materials.  

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Review a Subform’s Status

To check on the approval status of a subform:  

In your Work Area’s Project List, find the project for which the subform was created  

Expand the title to see the main application form and any supporting subforms along with their status and other details

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Understanding Subform Permissions

You can share a subform with any collaborators on the project. If you have used the Assign Role function in the Main REB Application Form to provide permissions to the Principal Investigator (PI), you do not need to share the subform. The PI will have access to all subforms throughout the project.

However, if you previously shared the main application with collaborators using the Share Form function and assigned specific permissions per individual, you will need to repeat this step for any subforms you wish to continue sharing with these collaborators.

To confirm whether you used the Assign Role or Share function previously:

1. Return to the Main REB Application Form (or SOI) and open the Collaborators tab
2. If you see a collaborator for whom you can edit the permissions, this means you only shared the main application form with them and you will need to re-share the subform
3. If you see a collaborator for whom you cannot edit the permissions, they are either the Form Owner or you assigned the PI role and you will not need to re-share the subform

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Sharing a Subform

To share a subform with a collaborator:

1. From your Work Area’s Project List (or the Project Tree), click into the subform you want to share

2. From the Actions pane on the left-hand side of your screen, click on the Share button  

   

3. In the Share pop-up window, enter the collaborator’s email and specify their permissions; to add another collaborator, click on the green Plus icon (or to remove them, click on the Minus icon)
   • Note: As with all EthOS applications, the collaborator must have an active account first in the system for their email to be a selection option

4. When you have finished adding all collaborators and their permissions, click on the Share button  

   

Collaborators receive a notification that you have shared the subform with them.  

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Deleting a Subform

Subforms can only be deleted before they are submitted.

To delete a subform:  

1. Navigate to the desired form

2. In the Actions pane on the left-hand side of your screen, click on the Delete Form button

   

3. Confirm your decision to delete your form by clicking on the green Delete button

   

EthOS displays a green banner message indicating that the form was deleted.  

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Duplicating a Subform

Duplicating a subform is useful especially for annual renewals. See the Duplicating Only Subforms steps in the Managing your Projects user materials for guidance.

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