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.
For eREB studies and migrated pre-eREB studies:
- 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.
For studies that are not yet migrated:
- Step 1: Complete the protocol deviation reporting form, with an original signature of the Site Investigator at the site where the deviation occurred. In lieu of an original signature, the submission email can be sent by the Site Investigator or by a research team member with the Site Investigator cc’d.
- Step 2: Submit an electronic copy of the complete submission to researchethics@unityhealth.to, with the subject line “REB <REB Number> – Protocol Deviation”. Incomplete submissions will be returned to the submitter.
- Step 3: The submission will be reviewed by the REB.
- Step 4: A copy of the form 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.
