Continuing Research Ethics Review
Continuing Research Ethics Review FAQ
Continuing Research Ethics Review FAQ Categories:
- A. General Questions
- B. Reports of Unanticipated Issues
- C. Request for Change to Cleared Research
- D. Annual Status Report
- E. End of Study Report
A. General Questions
- What if I don't have a copy of my Certificate of Research Ethics Clearance and I need it for my thesis binding?
- When do I have to update the REB?
- When can I submit a request to the REB?
1. What if I don't have a copy of my Certificate of Research Ethics Clearance and I need it for my thesis binding?
Certificates of Research Ethics Clearance are sent to the investigators at the time of initial research ethics clearance. The first step is to check with your faculty supervisor if you are unable to locate a copy. If you need a copy of your certificate at any point, please contact the Office of Research Ethics. The Office of Research Ethics has your master file and a copy of your certificate can be provided to you.
2. When do I have to update the REB?
Generally, researchers update the REB when:
- something unanticipated occurred in the research;
- when you are making changes to what has been cleared by the REB to date;
- if you change the title of your study,
- if team members or contact information for the research changes;
- your funding circumstances change (Example: You received new or additional funding for your research.)
Please don't hesitate to contact the Office of Research Ethics to ask your specific questions, whenever unsure. Understanding what needs formal REB clearance and what can be considered a courtesy update to the REB as well as understanding that the REB is a contact for the research, just as the investigators are; is a learning process. Researchers frequently speak with the Research Ethics Officer or the REB Chair to discuss their plans and receive guidance involving how to move forward given their specific circumstances during the entire lifecycle of the study. Please reach out with your questions and/or draft work for help and guidance. If you would like to book a time with the Research Ethics Officer at email@example.com, office hours are Tuesday and Thursdays 10 am to 12 pm.
3. When can I submit a request to the REB?
The REB accepts requests at any time during regular university business hours. If you have any questions, please contact the office for guidance at firstname.lastname@example.org or (902) 420-5728.
B. Unanticipated Issues Reporting Questions
- What happens if a participant of my research study experiences an adverse event?
- Will I receive a certificate involving the adverse event from the REB?
1. What happens if a participant of my research study experiences an adverse event?
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. 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.
Relating Reading: SMU REB Policy on Adverse Events
2. Will I receive a certificate involving the adverse event from the REB?
Once the Adverse Event Report has been reviewed by the Board, the REB Chair will provide written feedback from the REB meeting with any additional actions that may need to be taken. A certificate concerning adverse events is not issued.
C. Request for Changes to Cleared Research Questions
- What if I need to make changes to an already cleared application?
- Do I need to submit a modification request when someone new joins the research team?
- Do I need to submit a modification request when someone leaves the project?
- Do I need to submit a modification request when the proposed end date of my research study as indicated on my initial application has changed?
- How long does it generally take to get my modification request approved?
- Will I receive a certificate involving my modification from the REB?
1. What if I need to make changes to an already cleared application?
Researchers routinely make changes to the research plan, the informed consent form or script or supporting documents at any time, and as many times as needed. A Modification to Previously Cleared Proposals (Form 2), is submitted to the REB and you may employ the new changes in the conduct of your research when it is formally cleared by the REB. 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.
2. Do I need to submit a modification request when someone new joins the research team?
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. If that person is involved in, for example, library research or activities that are removed from participants, then no. For instance, the REB should be notified (via Form 2) if a student joins a research project and conducts it as part of his or her thesis. However, understanding that the REB is a contact to participants throughout the lifecycle of the research study, as are designated investigators and that this is conveyed to participants during the consenting process, researchers update their master files with the Research Ethics Officer in courtesy as well so the REB is better positioned to communicate fully with research participants at any point needed. Researchers frequently communicate with the Research Ethics Officer to understand the details of the reporting process in light of their specific circumstances.
3. Do I need to submit a modification request when someone leaves the project?
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 applicants are asked to ensure that the Office of Research Ethics is always updated on the correct contacts 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 Office of Research Ethics so the research master file is always 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.
4. Do I need to submit a modification request when the proposed end date of my research study as indicated on my initial application has changed?
It is not required that you formally amend the end of your study date. However, if the study date is extended and the date exceeds the period for which you have REB clearance (one year at a time, one year from the original approval date) you may need to submit an annual clearance request; an Annual Progress Report for Previously Cleared Proposals, (Form 3).
5. How long does it generally take to get my modification request cleared?
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 documents might be missing that would accompany the modification request form. This is normally not the case. Researchers generally provide well-written modification requests, include the documents they are changing and check off the applicable items on the request form. Researchers often request changes and receive their updated clearance from the REB. A certificate is not issued for modifications. Researchers receive communication about the clearance by email directly from the REB Chair.
6. Will I receive a certificate involving my modification from the REB?
No. A certificate will not be issued for amending a research plan, informed consent or supporting documents. You will receive an email notification from the REB conveying that the changes you requested have been cleared and you may start employing the changes immediately from that point onward. If you have any questions about the process or when you can begin implementing your changes exactly, please contact the Research Ethics Officer for guidance.
D. Annual Status Report Questions
- When should I send in my extension request?
- Will I receive a certificate involving my renewal/extension from the REB?
1. When should I send in my extension request?
If you would like to continue conducting your research beyond the date specified on your Certificate of Research Ethics Clearance, the REB asks that researchers submit an Annual Status Report (Form 3) a month prior to the expiry of the anniversary date of your most recent REB clearance expiry. The period for the research ethics clearance is stated on your original Certificate of Research Ethics Clearance or your most recent Certificate of Continuation.
2. Will I receive a certificate involving my renewal/extension from the REB?
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 your funder/sponsor, if applicable. You will receive an email notification from the Office of Research Ethics that your annual renewal request has been cleared and a Certificate of Continuation will be issued to the investigators of the project. It is the researchers responsibility to ensure that there is no lapse in approval for the research study.
The REB website lists all currently active studies. Researchers can look up their current clearance dates any time. If you have any questions or notice any discrepancies at any time, please contact the Research Ethics Officer at email@example.com or (902) 420-5728.
E. End of Study Report Questions
- When has research ended from the perspective of the REB?
- Will I receive a certificate involving my research completion from the REB?
1. When has research ended from the perspective of the REB?
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 researchers are experiencing is always available.
2. Will I receive a certificate involving my closure from the REB?
No. A certificate is not issued when the REB formally closes the master file at the Office of Research Ethics. The Completion of Research form (Form 5) is processed and the master file is closed. If you have any questions about the status of your research, completing the study or wanting to reopen a closed research file, please contact the Research Ethics Officer at any point, help and guidance is always available.