Research Ethics Board Applications
The standards by which the University of Toronto Research Ethics Board (REB) evaluates submissions are informed by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) . If you are unfamiliar with research ethics, the Council offers an excellent, online introductory course on research ethics. It consists of eight modules that focus on generalizable principles applicable to all research.
Answers to six questions about research ethics applications:
1. When do I require an REB and where do I submit my application?
You will require University of Toronto REB approval if you are conducting research involving humans under the auspices of the University of Toronto.
Toronto Academic Health Sciences Network (TAHSN) hospitals have their own REBs, and researchers should submit REB applications to their respective hospital REB for review. Researchers should also submit REB applications to the University of Toronto if recruitment, intervention, or interaction with human participants will take place on campus.
For TAHSN-based projects where the University of Toronto plays a peripheral role (administration of funds, graduate student involvement, and/or analysis or storage of personal data or biological samples), an Administrative Review must be completed.
Determining What Requires Approval
Refer to TCPS2 Article 2.5 for types of activities that are recused from REB approval. For example, quality assurance (QA) and quality improvement (QI) projects do not necessarily require REB approval. If the intent of the QA/QI project is internal use for assessment, management, or improvement purposes, then you may not require REB approval; however, if the intent is research (e.g., using a program evaluation as a generalizable case for the purpose of extending knowledge to other similar programs), then you may require REB approval.
Intent to publish and the use of rigorous data collection/analysis methods are not indicative of whether a project requires REB approval. Both research and QA/QI can be published, and both can use similar methodologies. Note that if data are collected for the purposes of QA/QI, and later used for research purposes, it is considered secondary use of data and may necessitate REB approval. Refer to this QA/QI research checklist (Word doc) to help determine if your project requires REB approval.
2. Which REB form do I have to complete?
Which University of Toronto REB submission form you require depends on your project and your role. The most commonly used forms are:
New Application form for Faculty Researchers (if you are the PI on the project),
New Application form for Supervised and Sponsored Research (if the PI is a supervised student and the supervisor is a faculty member)
Cover Sheet for TAHSN-approved applications for Administrative Reviews
3. Who is allowed to submit an application to the University of Toronto REB as a PI or supervisor?
PIs and supervisors must be University of Toronto faculty members with research privileges. Research privileges authorize the PI/supervisor to submit REBs, and they are outlined in your employment letter with the University of Toronto. Please refer to your employment letter for further information.
4. How do I obtain the Chair’s signature for my REB submission?
All DFCM faculty, staff, and students submitting REB applications through the DFCM requiring the signature of our Chair must first submit their REB application, relevant appendices (if applicable), and completed DFCM Resource Implication Form (Word doc) for REB Submissions to the Research Program for review. Once your REB application package is signed by the Chair, it will be returned to you, and it is then your responsibility to submit it to the University of Toronto REB.
Your submission to the University of Toronto REB has separate requirements. Please visit the Research and Innovation site for full instructions on their submission requirements and process.
To determine whether a QA/QI project requires REB review, submit your QA/QI research checklist to the Research Ethics Manager, Health Sciences.
5. What are the timelines for my REB submission?
The DFCM internal review of your REB application will take a maximum of two weeks. Once you have made necessary changes to your application, as suggested by the DFCM Research Program, and the Chair has signed your application package, you can submit it to the University of Toronto REB.
Applications for delegated review: the deadline for delegated review is every Monday (or first business day of the week) by 4 pm. You can expect to receive a response from the REB within 4-5 weeks.
Applications for full board review: the full board usually meets on a monthly basis. Considering the schedule of meeting dates and corresponding due dates, investigators are advised to submit well in advance of their anticipated start date.
6. What if I need to make a change to my approved REB protocol?
Minor variations to protocols are acceptable without the need for submission of an amendment. These changes should be addressed in the annual renewal or study completion form.
Any other proposed changes to an approved REB protocol require submission of an Amendment Request (Word doc). An amendment is any change to the study that affects scholarly intent, study design, or human participant protection. Any change to the protocol that alters the risk to participants, regardless of whether that change increases or decreases risk, requires an amendment.