Continuing REB Review Guidance

In order for a request to be registered for initial REB review, the SMU REB Standard Operating Procedure (SOP) REB Review Criteria must be met.  The criteria is listed in the REB's short standard operating procedures document.  When the criteria is met, the request will receive a SMU REB file number, and the review process will begin.  A request receipt will be issued that will detail SMU REB file number and confirm that review work is under way!

Generally, researchers update the REB when:

• new information about the research emerges;
• something unanticipated occurred in the research;
• there are alterations or changes to what has been cleared by the REB to date;
• the title of your study changes,
• team members or contact information for the research changes;
• funding circumstances or statuses change (Example: New or additional funding for the research is received.)

Please don't hesitate to contact the Office of Research Ethics to ask your specific questions, whenever unsure.  Understanding what needs REB review and clearance and what can be considered a courtesy update to the REB as well as understanding that the REB is also a contact for the research together with the investigators is a learning process. 

Researchers frequently discuss their former and current plans with the REB and receive guidance about next steps given their specific circumstances throughout the life cycle of the research.  Please feel free to reach out with questions and draft work for help and guidance.  If you would like to book a time with the Research Ethics Officer at ethics@smu.ca, office hours are Tuesday and Thursdays 1-3 pm. 

The REB accepts requests at any time during regular university business hours.

All adverse events of all magnitude must be reported to the SMU REB as soon as possible no later than one business day following the event. 

New information and ways the well-being of participants have been affected may prompt the need for REB review and a plan moving forward.  Possible outcomes are that researchers and the REB Chair discuss whether any, what particular or whether no changes to the current design of the research study should be adjusted.  The REB offers guidance throughout the lifecycle of the research study.  Feel free to reach out to discuss your circumstance.

Once the New Information and Unanticipated Issues Report has been reviewed by the Board, the REB Chair will provide written feedback with any additional actions that may need to be taken.  A certificate concerning new information and unanticipated issues is not issued.

Researchers routinely make changes to the research plan, the informed consent form or script or supporting/research documents at any time, and as many times as needed.   

A Request for Change to a Cleared Research Plan is submitted to ethics.continuingreview@smu.ca for continuing REB review. 

REB clearance is needed in order to apply the change in the research.  The REB understands and supports that it is during the time that researchers are conducting their studies that they learn and evaluate whether they wish to stick to their original design or wish to adjust it and add new items and ways they would like to proceed.  Making changes to the current research plan is encouraged any time, as researchers like. 

A good rule to remember is that the researchers' and the REB's master files need to match throughout the life cycle of the research. 

If the new team member is handling the data or is involved in an aspect of the project that involves contact with participants, then yes. For instance, the REB should be notified  if a student joins a research project and conducts it as part of his or her thesis, new investigators join locally or from another institution, etc.  These changes are common.  If that person is involved in, for example, library research or activities that are removed from participants, then no. Such changes may be updated during the Annual Status Report as general course of clearance renewal business. 

However, understanding that the REB is a contact to participants throughout the lifecycle of the research study together with the investigators as it is conveyed to participants during the consenting process, researchers update their master files with the REB in courtesy as well so the REB is better positioned to communicate fully with research participants at any point needed. 

A good rule to remember is that the researchers' and the REB's master files need to match throughout the life cycle of the research. 

Normally, the REB would not need to be notified if someone leaves the project however, in cases where the supervisor of the student project would no longer hold SMU affiliation by leaving the campus and a new supervisor is required, such a change must be reported to the REB. 

As a general rule researchers are asked to ensure that the REB is always updated about the team composition and the correct roles and affiliations  involving the research until the study is formally closed by the REB.  While there may not be a formal requirement involving some instances, it is always good practice to update the REB so the research master file is always fully up-to-date.  This is important so the REB is best positioned to communicate with research participants fully during the lifecycle of the research study. 

It is not required that researchers formally amend the end of the study date.  However, if the study date is extended and the date exceeds the period for which the current research plan holds REB clearance (one year at a time, one year from the original clearance date) an Annual Status Report is submitted to request to extend the REB clearance period. 

Change requests must be sent to ethics.continuingreview@smu.ca to avoid delays. It depends on the type of request, whether it is minor or major in nature how long investigators and the REB discuss the change that is being requested.  Revisions to the request may be needed or the updated documents might be missing along the request.  This is normally not the case.  Researchers generally provide well-written requests, include the new documents or the documents that are changing and highlight the changes within the documents and receive clearances quickly.

No.  A certificate will not be issued for changes to the current research plan. 

An email notification is issued from the REB conveying when the changes that have been requested have been cleared.  Changes may be implemented immediately from that point onward.  

If you would like to continue conducting your research beyond the date specified by the initial REB review process, on your Certificate of Research Ethics Clearance, the REB asks that researchers submit an Annual Status Report 30 days prior to the expiry of the clearance expiry date. 

The REB clearance period for the current research plan is stated on the original Certificate of Research Ethics Clearance or the most recent Certificate of Continuation.  

Yes. As all active projects must have current REB clearance at all times, you will always have a valid certificate to evidence that you have valid research ethics clearance as it is a requirement of the TCPS 2, the University and the funder/sponsor of the research project, when applicable. You will receive an email notification from the Office of Research Ethics that the Annual Status Report has been cleared and a Certificate of Continuation will be issued.  It is the researchers responsibility to ensure that there is no lapse in REB clearance for the research study.

The REB website lists all currently active studies that hold SMU REB clearance.  Researchers can look up their current clearance dates at any time.  If you have any questions or notice any discrepancies at any time, please contact the Research Ethics Officer at ethics@smu.ca.

Since the primary purpose of the REB is to protect human research participants, a project is deemed to be complete when involvement with and risk exposure to participants has ended.  Please consult the Office of Research Ethics if you have any questions.  It is common that researchers discuss with the REB what promises they have made to participants and what their current intentions are involving the conduct of the study. Help and guidance understanding the regulations in light of the specific circumstances that researchers are experiencing is always available. 

No. A certificate is not issued when the REB formally closes the master file. The End of Study Report is processed and the master file is closed. 

If you have any questions about the status of your research, completing a study or wanting to reopen a closed research file, please contact the Research Ethics Officer at any point, help and guidance is always available.