Modifications, reports, and adverse events

Over the duration of a project, circumstances may change, and it may become necessary to modify your ethics approval. Modifications could include but are not limited to adding new researchers, updating surveys, extending the expiry date and changing the recruitment method.

In the event that there are changes to a project which has previously been approved by the HRECs or the Low Risk Panel, a Modification Request Form must be submitted. Modification forms can be accessed by logging into ResearchNow Ethics & Biosafety through your Okta dashboard. To submit a Modification Form:

1. Login to ResearchNow Ethics & Biosafety (through your Okta dashboard).
   
2. Open the project you want to modify and click on 'Create Sub Form' under the Actions menu on the left.
   
3. A pop-up appears. Select the modification form from the drop-down menu.
   
4. Click 'Create' to create and open your modification form.
   
5. Provide the date of the request and submit the form.
   
6. The Research Ethics, Integrity and Compliance Office will review the submitted information and unlock the approved main project form for modification.
   
7. You will be notified once the project form has been unlocked.
   
8. Please add the proposed changes to the main project application form and submit it for review.

An adverse event must be reported to the Research Ethics, Integrity and Compliance Office within 24 hours of the event.

The Adverse Events Form can be accessed by logging into ResearchNow Ethics & Biosafety (through your Okta dashboard).

1. Login to ResearchNow Ethics & Biosafety through your Okta dashboard.
   
2. Open the project you want to submit an Adverse Event Form for and click on 'Create Sub Form' under the Actions menu on the left.
   
3. A pop-up appears. Select the Adverse Event Form from the drop-down menu.
   
4. Click 'Create' to create and save your form. Provide the requested information and then submit the form for approval.