The memo and ‘Notification of Planned Protocol Deviation’ form will be updated and re-posted here, as required. Ensure that you are always accessing the most recent version.
Notifying the REB of a Planned Protocol Deviation During the Publicly Declared Emergency
Use the new Notification of Planned Protocol Deviation form to notify the REB of temporary changes to approved study procedures as a result of a publicly declared emergency AND the changes increase risk to participants or adversely affect the integrity of the data.
NOTE: A temporary halt of recruitment or of your study due to the publicly declared emergency does not require submission of the Notification of Planned Protocol Deviation form. If your study or recruitment is being stopped for other reasons (safety, efficacy, etc.), please report this to the REB as you normally would.
PROCESS: The Notification of Planned Protocol Deviation form:
- The form is to be completed during the publicly declared emergency and submitted electronically to your Research Ethics Coordinator or to firstname.lastname@example.org.
- OHSN-REB will review the submission in a timely manner.
- If we have any concerns about your planned deviation, we will outline these in a response email.
- If we have no concerns, you will be notified that your submission has been acknowledged and noted to file. We will not be approving any documents that are specific to the planned deviation.
The Research Ethics Office at 725 Parkdale Avenue, Civic Campus is currently closed, and all staff are working remotely; no hard copy submissions are being accepted at this time.
All submissions should be submitted electronically.
New Research Studies:
- New studies related to COVID-19 should be submitted electronically in the Clinical Research Registration form in IRIS well as an email to Nancy Camack at email@example.com, Dr. Saginur at firstname.lastname@example.org, and Dr. Cameron at email@example.com.
- All other new studies should be submitted electronically through IRIS.
- New studies unrelated to COVID-19 will continue to be reviewed; however, studies related to COVID-19 will be prioritized.
- If submitting a new application related to COVID-19, let your Research Ethics Coordinator or REBAdministration@toh.ca know immediately upon submission.
Existing Research Studies:
- All post approval submissions (i.e.: new Planned Protocol Deviation Form, Amendment Form, Continuing Review Form, Reportable Event Forms, Study Closure Form) must be submitted to the REB via email to your Research Ethics Coordinator or to REBadministration@toh.ca.
- Please include the REB Protocol Numbers as well as the submission type in the email subject line.
- If you are submitting a Continuing Review Form, please also include the study’s expiration date in the subject line to help the REB office ensure ethical approval does not lapse.
- For initial REB applications, the Principal Investigator, Co-Investigator and Department/Division Head signature pages can be digitally signed by the applicable party, or email confirmation can be uploaded into the application in lieu of the signature page.
- If the PI’s signature is requested on a response to a Review Letter issued by the REB, the response letter can be digitally signed by the PI, or email confirmation from the PI can be provided.
- In lieu of PI signature on REB post approval forms, all post approval forms submitted to REB should be sent by the PI or by a research team member with the PI cc’d.