Staff Services / Research Ethics / Research Ethics Board / Protocol Deviation

An unanticipated or unintentional divergence or departure from the expected conduct of an approved study that is not consistent with the current approved research protocol, consent document or study addenda. 

Deviations may or may not have a significant effect on the research participant’s rights, safety or welfare, or on the integrity of the data. Deviations are different from amendments in that they generally apply to a single occurrence or participant and are not intended at the time to modify the entire protocol.

All protocol deviations must be reported to the Research Ethics Board (REB) within 15 days of the study team’s awareness of the event.

1. Step 1: Log into the Unity Health eREB to complete and submit a Protocol Deviation form. For information on creating an account and logging in, please see the eREB page. Guides on completing post-approval submissions can be found in the eREB.
2. Step 2: The submission will be reviewed by the REB.
3. Step 3: An acknowledgement letter signed by the Chair or designee will be sent to the study team via email. 

For more details, read the guidelines for reporting protocol deviations.