In order for a request to be registered for initial REB review, the 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:
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.
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