Modifications, reports, and
unexpected adverse events (UAE)

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 HREC 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 appropriate modification form from the drop-down menu.
   
4. Click 'Create' to create and open your modification form.
   
5. Provide the details of the date of the request and submit the form.
   
6. The Human Research Ethics Office will review the submitted information and unlock the approved project for modification.
   
7. You will be notified once the project has been unlocked.
   
8. Please add the proposed changes to the project application form and submit it for approval.

An unexpected adverse event is an event that was not foreshadowed in the application approved by the HREC and must be reported within 24 hours of the event.

The Unexpected 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 UAE for and click on 'Create Sub Form' under the Actions menu on the left.
   
3. A pop-up appears. Select the UAE 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.