Humans in Research
Research involving human participants conducted by faculty members and graduate students under the auspices of the University of Toronto must be reviewed and approved by a University of Toronto Research Ethics Board (REB) prior to its commencement.
All of the Toronto Academic Health Sciences Network (TAHSN) hospitals have their own, independent REBs. All hospital-based reseaarchers must submit human participant research protocols to their respective hospital REB for review, and to the REBs of all hospitals involved in the research. Researchers should also submit protocols to their appropriate University of Toronto REB if recruitment, intervention or interaction with human participants will be done on campus. For hospital-based projects where U of T plays a peripheral role, please see Administrative Review, below.
The ORE offers one-to-one or group ethics consultations for researchers, study staff, and students prior to and throughout the ethics review process to assist in the development and conduct of ethically sound research protocols, providing advice in accordance with federal, provincial and institutional requirements and best practices. Consultations are also offered for community agencies and their researchers who have partnered with the University and for which the University REB is the REB of record.
Please email firstname.lastname@example.org well in advance of your intended REB submission due date to schedule a meeting date and time.
The default review process is full review, where a protocol is brought to a monthly REB meeting and reviewed by the entire board. The delegated (formerly known as expedited) review process involves review conducted by one member, or a subcommittee of the board. Determination of whether to submit through the full board or delegated review process involves evaluating the risk of the project.
The delegated (formerly known as expedited) review process involves review conducted by one member, or a subcommittee of the board. Deadlines for delegated and full reviews are posted according to REB.
The main criterion that is used to determine whether a protocol may be reviewed through the delegated process is risk. Only research that meets the threshold of minimal risk may be delegated. Minimal risk is defined as,
“The probability and magnitude of possible harms implied by participation in the research can reasonably be expected by participants to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research, or during the performance of routine physical or psychological examinations or tests.”
To evaluate risk for this protocol, consider:
- Group vulnerability i.e., any pre-existing vulnerabilities associated with proposed participant groups, e.g., relating to pre-existing physiological or health conditions, cognitive or emotional factors, and socio-economic or legal status.
- Research risk i.e., the probability and magnitude of harms participants may experience as a result of the proposed methods to be used and types of data to be collected, e.g., relating to physiological or health issues such as clinical diagnoses or side effects, cognitive or emotional factors such as stress or anxiety during data collection, and socio-economic or legal ramifications such as stigma, loss of employment, deportation, or criminal investigation (e.g., in the event of duty to report intent to cause serious harm, subpoena, or breach of confidentiality).
Please consider overall assessments of group vulnerability and research risk (i.e., low, medium, high) and locate the protocol in the matrix , below.
|Group Vulnerability||Research Risk|
A variety of additional factors might also lead to a project’s being escalated to full review–for instance, if the project is unusual, complex, or large scale, there could be an increased probability of harm and need for close review.
We accept electronic submissions exclusively by email (no hard copies), for both delegated and full REB reviews for all of our REBs. Please e-mail one electronic copy of your protocol and appendices as a single Word document or a pdf, with appendices pasted in at the end, to email@example.com. Electronic signatures are preferred.
All other submissions, which are not new (e.g., revisions and continuing review submissions), as well as general inquiries, should be sent to firstname.lastname@example.org.
The deadline for delegated review is every Monday (or first business day of the week) by 4 pm.
Submission due dates and meeting dates are determined by the respective REB. Please submit your protocol well in advance of your intended start date.
Ethics review submissions should normally not include thesis proposals, journal articles, or budgets.
Applicants are advised to refer to the Guide for Informed Consent Documents when preparing information and consent letters/forms.
The ORE accepts TAHSN harmonized protocol forms for all studies that have been submitted for hospital REB review. Please e-mail the approved protocol (including appendices) with the approval letter from the hospital REB, and the University of Toronto TAHSN Cover Sheet.
Each cycle through the delegated review process (i.e. initial review or review of revisions) takes approximately 4-5 weeks to complete from the date the study was sent to the reviewer. The overall duration of a given review will depend on how many rounds of revision are required.
Several guidelines have been created to assist researchers in development of ethics protocols that deal with specific disciplines or methodologies (e.g. participant observation, use of deception and debriefing) and general topics (e.g. compensation).
All research to be conducted in schools must have administrative consent/permission prior to recruitment. Some school boards, including the Toronto District School Board, require protocol review by their Research Committee before gaining administrative permission. Please contact the school board to be involved with your research for further information.
Ethics approvals are valid for up to one year and only cover research conducted as described in the ethics protocol.
Annual Renewal and Study Completion
Researchers wanting to continue with a project beyond the expiry date of their current ethics approval are required to submit an Annual Renewal of Ethics Approval form. This may be done up to 4 times, for a total of 5 years of approval of a protocol.
If the study is to continue beyond 5 years, a re-review of the protocol, through a full REB or delegated review (based on level of risk), must be conducted.
Once the objectives of the study have been met (data collection and primary analysis completed), the study may be closed. This requires the submission of a Study Completion Report.
Review and approval of Annual Renewals and Study Completion Reports take normally 2 weeks. As expiry of ethics approval may affect the status of funding, it is advised that these documents be submitted well in advance of ethics expiry dates. Please submit all Continuing Ethics Review forms and supporting documentation to email@example.com.
Post-Approval Review Site Visits
All currently active REB-approved protocols are eligible to be selected for a site visit as part of the Post-Approval Review (PAR) program. This program has been developed as part of the University of Toronto’s commitment to maintaining the highest ethical standards in research. PAR site visits are intended to be collegial and educational to actively promote awareness of the ethical and regulatory requirements governing human research while facilitating compliance with the REB-approved ethics protocol.
Any proposed changes to an approved research project requires submission of an Amendment Request.
Definition of Amendment
An amendment is a written description of (a) change(s) to an ongoing, currently approved protocol. Amendments include any change to the study documents that affect scholarly intent, study design or human participant protection. Rationale for this/these change (s) should also be provided. 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 change to the protocol that alters the risk to participants, regardless of whether that change increases or decreases risk, requires an amendment. Amendments may include (but are not limited to):
- Recruitment methods or materials
- Research personnel – if principal investigator or faculty supervisor changes
- Location of the research – if major addition or change that may require additional permission or review (e.g. new school board)
- Length of study or intervention if risk level changes
- Participant population, inclusion or exclusion criteria
- Privacy issues and/or the nature of the information being collected (e.g. adding data that in combination with existing information could potentially identify participants) or confidentiality of participants
- Data management plan – change in storage, retention or destruction – physical and electronic safeguards
- Informed consent forms (unless only minor wording), procedures, new findings or information (Note: changes identified in aforementioned aspects may require changes to information sheets, consent forms and recruitment materials)
- Conflicts of interests
- Funding source(s)
- Change(s) of other institutional REB or administration approval, including additions or removals
Administrative updates apply for non-significant changes to the study that the ORE needs to keep track of for administrative purposes. These may include:
- Research personnel – addition, removal or change of student, post-doctoral fellow, co-investigator or alternate contact
- Location of research – if minor addition or change (e.g. additional classroom within the school)
- Data management plan – change in personnel with access to identifiable data or biological materials
- Study title
Please submit the form, revised protocol and appendices to firstname.lastname@example.org. All changes should be made to the protocol or appendices in bold, with new version number and date as the page footer.
Researchers must report adverse or unanticipated events that occur to participants in the course of the research process using the Adverse/Unanticipated Events Report Form. Reporting to the ORE should be done as soon as possible to email@example.com.
Please see our FAQs for additional information.
If research is to be conducted or funded by another country, it is important to understand the legal and ethical requirements of that country.
Under the United States Department of Health and Human Services (DHHS) Human Subjects Protection Regulations §45 C.F.R.46.103 (The Common Rule), every institution engaged in human subject research supported or conducted by the DHHS, i.e. NIH-sponsored research, must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP).
U of T holds a Federal-Wide Assurance, which will cover all DHHS-supported research projects that have undergone ethics review at the University. Our Assurance is coded: FWA00005463 – U Toronto. For any questions regarding the use of the FWA or NIH funding, please contact Krista Montgomery at 978-2155 or firstname.lastname@example.org.
Under the FWA, all investigators submitting for DHHS-supported agency grants or contracts require education on the protection of human subjects in research. Assurance that an appropriate course has been taken is needed for all renewals and new applications once a decision on funding has been reached by the agency (in other words, no course – no funds). This includes the principal investigator(s), key personnel and subcontractors. Two online courses are recognized by the University of Toronto as fulfilling this responsibility. One is the newly-available “Introductory Tutorial for the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans”, which is available through the Interagency Panel on Research Ethics, available here. The other is the NIH-supported “Protection of Human Research Subjects: Computer-Based Training for Researchers” which is available at ohsr.od.nih.gov/cbt/. We recommend the TCPS tutorial, as it educates researchers on Canadian guidelines, which is more applicable to University policies. Both courses are recommended for all researchers, students and REB members to take, as they provide a good foundation for ethical conduct in human subject research.
According to Article 1.14 of the TCPS, “Research to be performed outside the jurisdiction or country of the institution which employs the researcher shall undergo prospective ethics review both (a) by the REB within the researcher’s institution; and (b) by the REB, where such exists, with the legal responsibility and equivalent and procedural safeguards in the country or jurisdiction where the research is to be done.”
It is therefore necessary for researchers conducting studies in countries with ethics review procedures to submit to an REB-equivalent in that country. If research is to be conducted in a country without such resources, or in regions where government knowledge of the project would jeopardize the research and/or where human rights violations are commonplace, documentation from a non-government agency or expert on the cultural appropriateness of the research is helpful, when available.
Course-based research involving human participants is a valuable part of students’ research experience. Course-based research may include undergraduate student-initiated projects, and undergraduate or graduate course template protocols. It is vital that such projects be designed and conducted with the same level of professionalism as graduate and faculty research.
The University is responsible for reviewing all course-based research involving human participants. Ethics review of these projects must adhere to the principles outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition (TCPS2). It is the responsibility of both the student and the supervisor/instructor to understand and comply with federal and University policies governing research involving humans and to submit an ethics protocol.
If you are an undergraduate or graduate course instructor with an assignment that involves human participants, you will need to complete an Undergraduate Course Template form or Graduate Course Template form to seek ethics approval for student projects.
If you are an undergraduate student conducting an independent research project for a course, you and your supervisor will need to complete an Undergraduate Ethics Review Protocol Form – Student-Initated Projects.
Several departments and faculties have established their own Delegated Ethics Review Committees (DERCs) to review course-based protocols. The DERC list and contact information are below. Faculty and students conducting course-based research requiring ethics review in all other units should submit a protocol to email@example.com
Course-based research reviewed through a DERC must be minimal risk. In exceptional circumstances if a unit supports higher risk course-based research, protocols must be submitted for ethics review through the appropriate Research Ethics Board (REB).
Delegated Ethics Review Committees Contacts by Campus
Find the appropriate contact by campus and department/faculty below. Faculty and students conducting course-based research requiring ethics review in any units not listed here, should submit a protocol to firstname.lastname@example.org
Department/Faculty (course prefixes)
|St. George Campus||Anthropology (ANT)||Naisargi Daveemail@example.com|
|Engineering (AER, APS, BME, CHE, CIV, ECE, MIE, MSE)||Paul Yoo, Jose Zariffafirstname.lastname@example.org,
|Environmental Studies (ENV)||David Powellemail@example.com|
|Geography (GGR)||Jun Zhang, Virginia Maclarenfirstname.lastname@example.org,
|Management (MGT)||Geoffrey Leonardelli, Scott Hawkinsemail@example.com, firstname.lastname@example.org|
|Pharmacy (PHM, PHC)||Paul Grootendorstemail@example.com|
|Kinesiology and Physical Education (KPE)||Luc Tremblay, Jeremy Knightfirstname.lastname@example.org, email@example.com|
|Psychology (PSY)||Alison Chasteen, Daphna Buchsbaumfirstname.lastname@example.org, email@example.com|
Sherri Klassen, Bill Magee
|University of Toronto Mississauga (UTM)||All UTM departments||Carla DeMarcofirstname.lastname@example.org|
|University of Toronto Scarborough (UTSC)||Anthropology and Health Studies||Andrea Charise, Bianca Dahlemail@example.com,
|Centre for Critical Development Studies and Geography||Adam Martin, Thembela Kepefirstname.lastname@example.org,
|Centre for French and Linguistics||Yoonjung Kang, Philip Monahanemail@example.com, firstname.lastname@example.org|
Blair Armstrong, Yoel Inbar
|Sociology||Ping-Chun Hsiung, Kathy Liddleemail@example.com,
Download the Annual DERC Report for Course-Based Protocols spreadsheet .
Research that occurs solely at a Toronto Academic Health Sciences Network (TAHSN) hospital needs only to be reviewed at the hospital, and, similarly, research that occurs solely at the University needs only to be reviewed at the University. However, in some circumstances, hospital-based human research may involve the University in a peripheral capacity: administration of funds, graduate student involvement and/or analysis or storage of personal data or biological samples*. For these peripheral activities, administrative review through the Office of Research Ethics (ORE) may be conducted in lieu of REB review. In situations where recruitment or data collection will be wholly or partly taking place at the University of Toronto, REB review will be required.
*Transferring biological samples from an external institution to U of T may require a Material Transfer Agreement (MTA).
For administrative or REB review, please submit:
- U of T Ethics Review Cover Sheet
- Approved TAHSN Human Subjects Research Ethics Application form
- Approved research protocol
- All appendices
- REB (of record) approval letter
All administrative and REB review submissions should be sent electronically to firstname.lastname@example.org. For questions on whether a study should be submitted for REB or administrative review, or any other questions, please contact the ORE at email@example.com or 416-946-3273.
According to TCPS, Article 2.5, “Quality Assurance and quality improvement (QA/QI) studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research… and do not fall within the scope of REB review.’”
However, many projects that fall within the category of QA/QI or program evaluation may contain an element of research, necessitating REB review. In many cases, such activities may involve identifiable and sensitive personal information.
To determine whether a QA/QI project requires REB review, and/or may involve risk due to the nature of personal information collected, please fill out the QA/QI determination form and submit it to Daniel Gyewu (firstname.lastname@example.org) or for social sciences and humanities please send to Dean Sharpe (email@example.com).
Activities exempt from research ethics review
- Principles to Determine Exemptions from Research Ethics Review
- OISE Professional Practice
- Language Consulting is Standard Professional Practice
- Toronto School of Theology Guidelines for the Preparation and Ethics Review of Doctor of Ministry Thesis Projects Involving Human Subjects
- Professional Writing and Communication Ethics at U of T Mississauga
- Rotman Designworks Research Ethics Review Exemption Statement
- Research exemption guidelines for museum studies and curatorial practice
- Faculty of Law Standard Professional Practice
While some protocols may be approved within the first round of review, the majority require some level of researcher response or revision to REB comments. Some helpful hints on how to respond include:
- Create a cover letter responding to each question/comment provided by the REB.
- Bold changes in the revised ethics protocol.
- Understand what the REBis asking for and why:
- Elaborate – provide further detail to the REB as the procedure or concept is not complete
- Clarify – provide further information to help the REB understand what you are doing and why
- Comment – your understanding of the respective ethical principles on the issue is being sought
- Justify – provide an explanation of why you have chosen the decision you have, as the decision may require the balancing or weighing of two or more ethical principles
- Understand that the REB must review research in accordance with Tri-Council Policy Statement, other regulations, University policies, guidelines and best practices. Please consult the Guidelines and Practices Manual for Research Involving Human Subjects for understanding of these requirements.
- Recognize that the REB system is a human process, similar to that of peer review. In many occasions, clarifying or justifying the protocol proposed is sufficient.
- If elaborate revisions are required, please contact the respective REB Manager well in advance of your intended REB submission due date to schedule a one-to-one or group ethics consultation.