1. PI to gather all relevant information, organize required documents for approval.
2. Submit the study through CAPCR. REB Approval is only one element of Institutional Approval (required to begin a study at UHN).
3.REB receives the study.
4. REB triages the incoming study based on several factors including risk.
5. Review assessment is conducted.
6. A decision to approve the study is made; modifications are requested; more information is required.
- The following graphic displays the timeline of the REB submission and review process:
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6
PI to gather all relevant information, organize required documents for approval.
Submit the study through CAPCR.
REB Approval is only one element of Institutional Approval (required to begin a study at UHN).
REB receives the study.
REB triage the incoming study based on several factors including risk.
Review assessment is conducted.
A decision to approve the study is made.
Modifications are requested.
More information is required.
- Initial Submissions
When submitting a study, the REB determines one of the following review paths, depending on the nature and risk profile of the submission. This application is only completed once per study.
- Full Board Review: greater than minimal risk
- Delegated Review: the study presents minimal risk to study participants
CAPCR is an online tool that manages the electronic submission process for clinical research studies by streamlining the approval process. CAPCR compiles and coordinates approvals from different departments (including REB) and allows you to track your progress towards achieving Institutional Approval. To learn more about the CAPCR application, click here.
UHN's CAPCR can be accessed internally from the research network, or externally through the Remote login page.
*For issues accessing the CAPCR application, please contact the CAPCR team directly.
Is the research study open to accrual/enrolment?
|Renew via CAPCR||Question 2
Is the research study closed to enrolment but subjects are still participating in research procedures outlined in the protocol?
|Close via CAPCR|
Is data clarification, analysis and/or data transfer ongoing?
For Study Closures, please ensure that the form is completed and submitted via CAPCR as soon as possible after your study is complete and no later than 14 calendar days prior to REB Expiry.
- Events that Should be ReportedAny event that meets the following criteria:
- Protocol Deviation
- Adverse Event
- Other Unanticipated Event
- The incident is unexpected (in terms of nature, severity, or frequency) when considering the research procedures that are described in the protocols (eg, informed consent document[s], investigator brochure, product monograph, device manual, etc., or the characteristics of the research participant population being studied)
- The incident or research approach places research participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized
- The incident, experience, or outcome may have been caused by the investigational product(s) or procedures involved in the research
To report an unanticipated event at UHN, please do so via CAPCR.
- Do I need REB review for my study?
All research involving humans or confidential patient information within UHN requires approval of the UHN REB prior to the initiation of a research project.
Investigators from other institutions who wish to carry out research on UHN premises or with UHN patients or patient data must also apply to the UHN REB.
- What counts as research?
The definition of research is outlined in the Tri-Council Policy Statement. In summary, research involving humans is considered to include any of the following:
- if the researcher will administer a drug, take a blood sample, do a test or perform any procedure, clinical, therapeutic, or otherwise, upon the person of himself/herself or someone else, for research rather than treatment
- if the researcher will ask people information whether by telephone, letter, survey, questionnaire or interview
- if the researcher will review information from patient charts (even their own patients' charts) for research rather than clinical purposes
- if the researcher will use material derived from people (tissue samples, blood, DNA)
- if the researcher will be using non-public records (e.g. not the telephone book) which contain identifying information about anyone either directly or indirectly
- if the researcher will use information previously gathered about anyone, even if anonymized (secondary data analysis)
- if the researcherwill be observing anyone's responses or behaviour, either directly or indirectly
If you cannot determine whether an intended investigation constitutes research, contact the Chair of the REB or an Ethics Coordinator for assistance.
- What does not count as research?
- Research involving only the use of published or publicly available information or materials
- Assessment activities such as quality assessment studies, performance reviews, or testing within normal educational requirements do not generally require REB review and approval
If you cannot determine whether an intended investigation constitutes research, contact the Chair of the REB or an Ethics Coordinator for assistance.
- How does the REB review protocols?
In accordance with the Tri-Council Policy Statement, the UHN REB conducts a proportionate review of research protocols: that is, the scale of the review is in accordance with the type of research proposed and with the potential for harm that the research may pose
- What research qualifies for delegated review?
The decision to delegate a research project is made by the Co-Chairs of the REB. Some criteria by which research may qualify for delegated review are:
- Protocols involving minimal risk or protocols where there are minimal incremental risks over standard procedures
- Minimal risk protocols where data are collected non-invasively such as questionnaires or direct/indirect observation
- Protocols primarily using previously-collected data such as chart reviews and database information
- Protocols using previously-collected tissue or other samples
- Who reviews my proposal?
The REB is comprised of four panels. The panel to which proposals are directed for review depends on:
- The subject of the research proposed
- The scientific expertise of the panel
- In the case of the two multidisciplinary panels (A and B), the current workload of each panel is considered
- Who decides who reviews my proposal?
Decisions as to which panel reviews each proposal are made by the Co-Chairs of the REB in consultation with REB Coordinators.
- Why does the REB review the study budget?
The REB examines the budgets of clinical trials in accordance with Tri-Council Policy Statement (TCP) Article 7.3 which states that "REBs shall examine the budgets of clinical trials to assure that ethical duties concerning conflict of interest are respected" and does so from the perspective of :
- Conflict of Interest
- How do I find out the status of my protocol application?
- Where is the UHN REB located?
700 Bay Street
LuCliff Place, 17th Floor, Suite 1700-1
Toronto, Ontario M5G 1Z6
- Where can I get information about the Research Ethics Board fee?
The REB fee is levied and collected by Research Solutions and Services through Grant and Contract Services and is used to partially offset the costs incurred by Research Solutions and Services in providing support to the REB. For more information, please see the Grant and Contract Services FAQ.
- When should I submit a pregnancy follow up consent form to the REB?
A consent form for pregnancy follow up must be submitted in the event of pregnancy.
Considering it is rare that research participants (or their partners) become pregnant while participating in a clinical research study, to facilitate review and approval process, the REB does not recommend submitting a consent form for pregnancy follow with the initial submission, unless required by the study objectives.
- How do I make the required changes to documents that have been reviewed by the REB?
When revising documents that have been reviewed by the REB, the requested revisions should be tracked and made on a clean copy the REB reviewed document. Please ensure that the version dates of the document are updated. Once all the revisions have been completed, send both a ‘tracked’ copy and a ‘clean’ copy of the document back to the REB. Please note that the REB will not accept documents that include both new revisions and the revisions that were previously reviewed by the REB.
- Can a participant be given new information which may influence their current consent prior to REB approval?
Consent is an ongoing process and participants should be provided with any and all new information that may influence their consent.
New information may be provided, verbally or otherwise, to participants prior to receiving REB approval if the Principal Investigator:
- determines it to be in the best interests of already consented participants (i.e. to eliminate or reduce any apparent immediate hazards to study participants)
- documents the process
- submits all new information and documentation to the REB for confirmation of agreement as soon as possible within seven days.
- Why is there often more than one set of questions during a review?
It is the nature of research that answers often lead to more questions and the REB review element of research is no different.
An REB review is an iterative process between the PI and the REB which continues until such time as all elements have been satisfactorily addressed.
In the course of review, information provided by the study team may result in requests from the REB:
a) to modify elements of the study
b) for more information
At the conclusion of the review, the REB will provide one of the following decisions concerning the study:
b) Not Approved
c) Approval Not Required
Please see the link http://intranet.uhnresearch.ca/service/understanding-review-process which describes the review process.
*Please note that deadlines are only provided for initial submissions. Should any Amendments or Renewals need to be considered for review during a Full Board meeting, they must be submitted 2 weeks prior to the appropriate Board’s deadline date.
|Panel||Meeting Date||Initial Application Deadline|
|Amendment / Renewal / Closure Requiring Full Board Review|
|Biomedical A||Monday, January 08, 2018||Wednesday, December 20, 2017||Monday, December 11, 2017|
|Biomedical B||Monday, January 22, 2018||Wednesday, January 03, 2018||Monday, December 25, 2017|
|Oncology||Friday, January 26, 2018||Friday, January 12, 2018||Friday, December 29, 2017|
|Biomedical A||Monday, February 12, 2018||Wednesday, January 24, 2018||Monday, January 15, 2018|
|Oncology||Friday, February 23, 2018||Friday, February 09, 2018||Friday, January 26, 2018|
|Biomedical B||Monday, February 26, 2018||Wednesday, February 07, 2018||Monday, January 29, 2018|
|Biomedical A||Monday, March 12, 2018||Wednesday, February 21, 2018||Monday, February 12, 2018|
|Oncology||Friday, March 23, 2018||Friday, March 09, 2018||Friday, February 23, 2018|
|Biomedical B||Monday, March 26, 2018||Wednesday, March 07, 2018||Monday, February 26, 2018|
|Biomedical A||Monday, April 09, 2018||Wednesday, March 21, 2018||Monday, March 12, 2018|
|Biomedical B||Monday, April 23, 2018||Wednesday, April 04, 2018||Monday, March 26, 2018|
|Oncology||Friday, April 27, 2018||Friday, April 13, 2018||Friday, March 30, 2018|
|Biomedical A||Monday, May 07, 2018||Wednesday, April 18, 2018||Monday, April 09, 2018|
|Oncology||Friday, May 25, 2018||Friday, May 11, 2018||Friday, April 27, 2018|
|Biomedical B||Monday, May 28, 2018||Wednesday, May 09, 2018||Monday, April 30, 2018|
|Biomedical A||Monday, June 11, 2018||Wednesday, May 23, 2018||Monday, May 14, 2018|
|Oncology||Friday, June 22, 2018||Friday, June 08, 2018||Friday, May 25, 2018|
|Biomedical B||Monday, June 25, 2018||Wednesday, June 06, 2018||Monday, May 28, 2018|
|Biomedical A||Monday, July 09, 2018||Wednesday, June 20, 2018||Monday, June 11, 2018|
|Oncology||Friday, July 27, 2018||Friday, July 13, 2018||Friday, June 29, 2018|
|Biomedical B||Monday, July 30, 2018||Wednesday, July 11, 2018||Monday, July 02, 2018|
|Biomedical A||Monday, August 13, 2018||Wednesday, July 25, 2018||Monday, July 16, 2018|
|Oncology||Friday, August 17, 2018||Friday, August 03, 2018||Friday, July 20, 2018|
|Biomedical B||Monday, August 27, 2018||Wednesday, August 08, 2018||Monday, July 30, 2018|
|Biomedical A||Monday, September 10, 2018||Wednesday, August 22, 2018||Monday, August 13, 2018|
|Biomedical B||Monday, September 24, 2018||Wednesday, September 05, 2018||Monday, August 27, 2018|
|Oncology||Friday, September 28, 2018||Friday, September 14, 2018||Friday, August 31, 2018|
|Biomedical A||Monday, October 15, 2018||Wednesday, September 26, 2018||Monday, September 17, 2018|
|Oncology||Friday, October 26, 2018||Friday, October 12, 2018||Friday, September 28, 2018|
|Biomedical B||Monday, October 29, 2018||Wednesday, October 10, 2018||Monday, October 01, 2018|
|Biomedical A||Monday, November 05, 2018||Wednesday, October 17, 2018||Monday, October 08, 2018|
|Biomedical B||Monday, November 19, 2018||Wednesday, October 31, 2018||Monday, October 22, 2018|
|Oncology||Friday, November 23, 2018||Friday, November 09, 2018||Friday, October 26, 2018|
|Biomedical B||Monday, December 10, 2018||Wednesday, November 21, 2018||Monday, November 12, 2018|
|Oncology||Friday, December 14, 2018||Friday, November 30, 2018||Friday, November 16, 2018|
|Click here to view 2017 dates|
|Click here to view 2016 dates|
|Click here to view 2015 dates|
- Research Ethics Coordinators & Analysts
Name Position Phone Number Role Lisungu Chieza
Research Studies Coordinator 416-581-7848 (18-7848) Board A Lead Svetlana Tzvetkova
Research Studies Coordinator 416-581-7845 (18-7845) Board B Lead Larissa Potanina
Research Studies Coordinator 416-581-8143 (18-8143) Board C Lead, Retrospective Biospecimens Studies
and Unanticipated Problems
Research Studies Coordinator 416-581-7850 (18-7850) Delegated & DOCH Lead Jasmin Bico-Ponce
Research Studies Coordinator 416-581-7827 (18-7827)
Research Studies Coordinator 416-581-7767 (18-7767)Nicholas Phan Research Studies Coordinator 416-581-7831 (18-7831) Kristina Commisso
Research Studies Coordinator 416-581-7817 (18-7817) Ralph Pastore
Name Position Phone Number Paul MacPherson
Director, Grants, Contracts and Ethics Review Services 416-581-8573 (18-8573) Anita Sengar
Manager, REB Operations 416-581-7546 (18-7546) Alexander Karabanow
Manager, Clinical Research Services 416-581-7525
- REB Chairs & Vice Chairs
Name Position Phone Number Role Dr. Morris Sherman
Chair, Research Ethics Board 416-586-4800 (17-8495) Panels A & B: Biomedical Dr. Jack Holland
Chair, Research Ethics Board 416-581-7450 (18-7450) Panel C: Oncology Dr. Connie Marras
Vice-Chair, Research Ethics Board 416-603-6422 (13-6422) Panel A: Biomedical Dr. David Barth
Vice-Chair, Research Ethics Board 416-340-4914 (14-4914) Panel B: Biomedical Dr. Paul Oh
Vice-Chair, Research Ethics Board 416-597-3422 x 5263 Panel D: Rehabilitation medicine and Science
- Consent FormsREB-created document to aid in the creation of a study specific consent formTemplate for consenting participants for follow-up upon pregnancy
Sample Addendum to Consent Form REB-created document to aid in the creation of an addendum to an existing study specific consent form
- Guidelines & Supporting DocumentsGuidelines, definitions, sub-study information, exceptions, and procedures regarding study amendments. Version date: June 30, 2017
Attestation Policy Memo stating the UHN REBs policy on signing the REB Attestation FormInstructions for writing a consent form. Contains Confidentiality Clauses. Version date: January 26, 2017 UHN-REB Guidance on Case Reports Instructions for writing Case Reports.Guidance document provided by CAREB. UHN REB: Guidance on Providing New Information to Study Participants Guidelines, definitions and instructions on providing new information to participants. Version date: August 22, 2017Sample protocol for guidance.US Department of Health and Human Services: Office for Human Research Protections (OHRP)US Department of Health and Human Services FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRB UHN Guidance on Pregnancy Prevention UHN Guidance on Pregnancy Prevention Pregnancy Prevention Information Sheet Pregnancy Prevention Information Sheet
Consultations can take place prior to submission or after submission of applications to the REB. This service is offered by UHN's Research Ethics Education program and the REB.
- What are the kinds of issues that the Research Ethics Consultation Service can help with?Examples of the kind of questions that the consultation service might assist with include, but are not limited to, the following:
- Am I confident that the anticipated benefits of my research will outweigh its risks?
- How do I know if the consent process that I am anticipating using for my research is the most appropriate one, given special characteristics of my research population?
- Should I do anything about the fact that my research is controversial in the eyes of many in the public?
- Consultations required for the following types of studies
- Studies of first-time users (PIs)
- Coordinating Center studies where UHN will serve as the coordinating center for a multi-center study
- Studies involving an investigational drug/device/biologic where the UHN investigator holds the Investigational New Drug (IND) or Investigational Device Exemption (IDE)
- Genome-Wide Association Studies (GWAS) if it is the PI’s first such study Banking/Repository studies if it is the PI’s first such study
- Consultations recommended for the following types of studies/questions
- Questions about “engagement” of other institutions/sites in research
- Questions about whether certain groups qualify as “human subjects”
- Questions about Privacy and Confidentiality
- Questions about inclusion of Special Populations
- Studies involving multiple institutions (consultation strongly recommended to avoid unnecessary work or multiple REB review)