When & How to Submit Renewals, Protocol Completions, Adverse Events & Protocol Deviation Reports

Renewals are required for research that will continue beyond the Research Ethics Board (REB) approval expiry date. This is usually on the anniversary date of the initial REB approval, but not always, so please check the expiry date on the approval letter. Continuing research is defined as all ongoing activities needed to fulfill the primary objectives of the study. These include recruitment, interaction/intervention with participants, data collection and analysis.

Renewal applications are submitted on MRHP as part of the protocol file. Renewals may involve only an extension of the expiry date (by up to one year) or may also include necessary changes to the protocol. The latter is a combined renewal/amendment and may take longer for the REB to review and approve. Please see How to Amend a Protocol to determine what types of changes require an amendment.

Renewals are reviewed “just-in-time” of expiry, to comply with TCPS2 requirements of REB approvals of only up to one year. MRHP generated reminders to submit a renewal will be sent out until the renewal is approved. If concerned that an expiry date is approaching and notification of approval has not been received, please check the status by using Status History on MRHP.

Protocol Completion Reports (PCRs) must be submitted at the end of a research study to keep the file in good standing, in accordance with TCPS2 and Tri-Agency funding requirements.

Protocol completion is defined as the point of the study where all primary objectives of the research (as described in the Project Details section on MRHP) have been met and all interaction or intervention with participants, data collection or data analyses as described in the protocol is complete. Once a PCR is approved, the file is closed in good standing and cannot be reopened. Any subsequent research activities will require a new protocol submission.

PCRs can be submitted at any time and do not need to wait until notification that an expiry date is approaching. Allowing a protocol to expire in lieu of submitting a PCR may result in the freezing of funds and/or other consequences.

TAHSN hospital REB-approved protocols that have undergone the administrative review process at U of T require submission of renewals or protocol completion reports to remain in good standing. Expiry dates are those indicated on the TAHSN hospital REB approval letter.

Please note, the MRHP system will send an automated email reminder three months prior to the expiry date. Please wait until the TAHSN hospital REB renewal approval letter (with new expiry date) has been received. Include the following in the renewal submission.

• Copy of TAHSN hospital REB renewal approval letter
• Other new or revised documentation, if relevant

Please submit a PCR once the study is complete, in accordance with U of T’s definition of protocol completion above. It is understood that some TAHSN institutions may use other definitions. It is acceptable to maintain an open protocol, through renewal, at the University, while the protocol is closed at the respective TAHSN hospital.

Adverse events may occur to participants during the conduct of human research. As well, a researcher may deviate from the REB-approved protocol, whether intentionally to reduce risk to participants, or unintentionally. Sometimes these two actions are related.

An adverse event is defined as an occurrence or issue that occurs during the conduct of research with an undesirable outcome for the participants which may increase the level of risk to participants or have other ethical implications that may affect participants. These types of events may be unanticipated or anticipated by researchers.

A protocol deviation is any change, divergence, or departure from the study design or procedures defined in the protocol, consent document, recruitment process, or study materials originally approved.

Adverse Event and/or Protocol Deviation reports must be submitted to the REB through MRHP as soon as possible. Submission of a report does not indicate wrongdoing. Instead, it provides the REB with the necessary information to determine whether the risk level has changed, and whether any follow-up by the researcher or REB is necessary. If the researcher determines that the protocol should be changed for current or subsequent participants, an amendment is required.

• Provide guidance on how and when to submit a renewal or protocol completion report.
• Provide advice on administrative review procedures.