We are pleased to inform you that we will be transitioning the TAHSN Board of Record (BoR) model to Clinical Trials Ontario (CTO). This is a positive step toward providing the TAHSN research community with a streamlined approach to REB review. This means the TAHSN Board of Record is no longer accepting new studies for ethical review. For those who currently have active studies in the TAHSN BoR model, we will contact you with a plan to transition your study to CTO.
For more information on the transition plan and how this might affect you, please contact:
TAHSN Board of Record: email@example.com
Clinical Trials Ontario: firstname.lastname@example.org
The Toronto Academic Health Sciences Network Board of Record (TAHSN BoR) allows qualified TAHSN institutions to defer research ethics oversight to a single Research Ethics Board, called the Lead REB, for studies that involve two or more qualified TAHSN institutions. With this process, Principal Investigators at the participating sites can accept the research ethics review of the Lead REB at another TAHSN institution. The following TAHSN institutions have been qualified and may participate in the TAHSN BoR:
- Baycrest Health Science
- Holland Bloorview Kids Rehabilitation Hospital
- Centre for Addiction and Mental Health
- Sinai Health System
- St. Michael’s Hospital
- Sunnybrook Health Sciences Network
- The Hospital for Sick Children
- University Health Network
- Women’s College Hospital
In the TAHSN BoR model, one investigator, called the Lead Applicant, assumes responsibility for submitting initial and ongoing submissions to the Lead REB on behalf of all participating TAHSN sites.
Principal Investigators from the participating sites, called the Site PIs, are not entirely relieved of responsibility as they are required to provide the Lead Applicant with information specific to their site and notify the Lead REB of all site-specific revisions, amendments, new information, site-level reportable events (i.e. SAE’s, deviations, privacy breaches) etc.
To apply to use the TAHSN BoR for ethical review of your study, the Lead Applicant is to submit:
- One Request Form (for the Lead Applicant's site)
- One Site-specific Form (for each participating site)
All forms can be found in the “Resources: Forms” section of this website.
If you have any questions, please contact the TAHSN BoR Navigator at email@example.com.
- Resources: Forms
Link to Form Description Request Form One Request Form is to be completed (with the Lead Applicant's info) per study. Site Specific Form One Site-Specific Form is to be completed for each proposed site in the study. Continuing Review Form This form is to be filled out by the Lead Applicant and submitted 2 weeks before the expiry date of the study's current Lead REB Approval.Note: The Continuing Review Form must also be accompanied by one Continuing Review - Addendum A (Site PI Declaration and Signature) for each participating site, excluding the Lead Applicant's site. Continuing Review Form - Addendum A (Site PI Declaration and Signature) This form must be signed by each Site PI involved in the research study and submitted with the Continuing Review Form. Continuing Review Form - Addendum C (For Lapsed & Expired Studies) This form is to be used when there has been a study or site lapse in ethical approval. It is to be submitted along with the Continuing Review Form. Amendment Form Any changes to the study must be submitted using an Amendment Form. All amendments to currently approved research studies must be filled out by the Lead Applicant and approved by the Lead. REB prior to implementation.
Note: Some situations may require implementation of an amendment before receiving REB approval to eliminate the risk of harm to research participants. In these cases, the Lead REB should be notified ASAP.
Amendment Form - Addendum A (Site PI Declaration and Signature)
This form must be signed by each approved Site PI impacted by the changes outlined in the Amendment Form.
Site Closure Form The Site Closure Form must be completed by the Lead Applicant when closing a site. A form must be submitted for all sites, including the Lead Applicant's, before submitting the Study Closure Form. Site Closure Form - Addendum A (Site PI Declaration and Signature) This form must be signed by each approved Site PI impacted by the changes outlined in the Site Closure Form. Study Closure Form The Study Closure Form must be completed by the Lead Applicant only after a Site Closure Form have been submitted for all sites have been closed by submitting . Site PI Change Form Site PI Change Form must be completed by the Lead Applicant, the out-going PI and the incoming PI. Site-Level Reportable Events Form This form can be used to submit site-level reportable events to the Lead REB. Lead-Level Reportable Events Form This form can be used to submit lead-level reportable events to the Lead REB.
Note: All forms are to be submitted by email to firstname.lastname@example.org.
- Resources: SOPs and Tip Sheets
SOP001 - How to Apply to the TAHSN BoR A standard operating protocol (SOP) that explains how to apply to the TAHSN BoR. SOP002: How to Obtain an REB Decision Letter A standard operating protocol (SOP) that explains how to obtain an REB decision letter. SOP003: How to Receive a Fully Executed TAHSN BoR Study Agreement A standard operating protocol (SOP) that explains how to receive fully executed TAHSN BoR study agreements. SOP004 - The Process of Continuing Review for Ongoing Research Studies Standard Operating Protocol (SOP) that explains the process of continuing review for ongoing research studies SOP005 - The Process for Amendments Standard Operating Protocol (SOP) that explains the process for amendments SOP006 - The Process for Closing a Site Standard Operating Protocol (SOP) that explains the process for closing a site SOP007 - The Process for Closing a Study Standard Operating Protocol (SOP) that explains the process for closing a study SOP008 - The Process for Submitting a Site-Level Reportable Event COMING SOON - Standard Operating Protocol (SOP) that explains the process for submitting a site-level reportable event SOP009 - The Process for Submitting a Study-Level Reportable Event COMING SOON - Standard Operating Protocol (SOP) that explains the process for submitting a study-level reportable event Tip Sheet: BoR Navigator responsibilities Step-by-step instructions and checklists that explain the role of the BoR Navigator in the TAHSN Board of Record process Tip Sheet: Instructions for Lead REB in BoR Process Step-by-step instructions and checklists that explain the role of the Lead REB in the TAHSN Board of Record process Tip Sheet: Lead Applicant Responsibilities Step-by-step instructions and checklists that explain the role of the Lead Applicant in the TAHSN Board of Record process Tip Sheet: Site Navigator Responsibilities Step-by-step instructions and checklists that explain the role of the Site Navigator in the TAHSN Board of Record process Tip Sheet: Site PI responsibilities Step-by-step instructions and checklists that explain the role of the PI in the TAHSN Board of Record process
- Site Navigators/ REB Contacts for TAHSN Hospitals
Link to Site REB Site REB Contact Site BOR Contact Site Address Baycrest 416-785-2500 ext. 2440 Roshan Guna, 416-785-2500 ext. 2440
Research Ethics Office, Baycrest
Suite 820 Brain Health Complex
3560 Bathurst Street
Toronto, ON M6A2E1
Centre for Addition and Mental Health 416-535-8501 ext. 36352 Greg Staios, 416-535-8501 ext. 36352
CAMH Research Ethics Board
33 Russell Street, Room T116
Toronto, ON M5S2S1
Holland Bloorview 416-425-6220 ext. 3507 Marie Steele, 416-425-6220 ext. 3507
Holland Bloorview Research Ethics Board
150 Kilgour Road
Toronto, ON M4G1R8
Mount Sinai Hospital 416-586-4875 Kathleen Austin, 416-586-4800 ext. 4726
Mount Sinai Hospital Research Ethics Board
Hydro Building (OPG)
700 University Avenue
Toronto, ON M5G 1Z5
SickKids Hospital 416-813-8279 David Kenney, 416-813-7654 ext. 205718
Research Ethics Board Main Office
Room 5515, Hill Wing
555 University Avenue
Toronto, ON M5G1X8
St. Michael's Hospital 416-864-6060 ext. 2557 Sharon Freitag, 416-864-6060 ext. 2385
Research Ethics Office, St. Michael's
250 Yonge Street, 6th Floor
Toronto, ON M5B2L7
Sunnybrook Health Sciences Centre 416-480-6100 ext. 88144 Keri Durant, 416-480-6100 ext. 89518
(MAT LEAVE) Tiffany Tassopoulos, 416-480-6100 ext. 88144
Research Ethics, Human Research Protections Program, SRI
2075 Bayview Avenue, Room C8 19
Toronto, ON M4N3M5
University Health Network 416-581-7849 Anita Sengar,
UHN Research Ethics Board
700 University Avenue
Hydro Building, 10th Floor Suite 1056
Toronto, ON M5G1Z5
Women's College Hospital 416-351-3732 ext. 2535 Melissa Sidhu, 416-351-3732 ext. 2723
Research Ethics Board Office, WCH
790 Bay Street, Room 746
Toronto, ON M5G2M9
- For Lead REB ONLY
The following approval forms should be sent from the Lead REB to the Navigator for dissemination.
Form Purpose Guidance Document Lead REB Approval Letter
Used to communicate the following approvals: Initials, Amendments, etc.
Lead REB Approval Letter Guidance Document Lead REB Continuing Review Approval Letter Used to communicate the following approvals: Initials, Amendments, etc. Lead REB Continuing Review Approval Letter Guidance Document Lead REB Correction Letter Used in cases where a previously sent approval letter needs correction or a document that was approved was omitted from the letter by mistake. Lead REB Closure Letter Used to close a site and/or study.*These forms are only to be used and completed by the Lead REB. All forms are password protected. If you cannot open a form, right-click on the hyperlink and "save link as" or "save target as" to save the form to your computer to open. If your forget the password or are having difficulty opening the forms, please contact the Navigator for a copy of the desired form.
- Frequently Asked Questions
TAHSN BoR Application:
Q: I am a Principal Investigator at UofT and would like to conduct research at multiple TAHSN institutions. Can I apply to use the TAHSN Board of Record (BoR) process?
A: Only institutions whose REB has gone through a qualification process are eligible to apply through the TAHSN BoR model. To find out if your institution is qualified, or if your institution has qualified a particular TAHSN institution’s REB, please contact the TAHSN Navigator.
Q: I have submitted an application to use the TAHSN BoR to add a qualified TAHSN site to an existing REB-approved study. If my application is accepted, what approvals do I need before beginning the study at the new site?
A: The process does not change for studies who have already received an initial approval letter. You will still need to apply to the Lead REB, following their normal processes, to add a new site. If the Lead REB approves the addition of a new site, a new REB approval letter will be issued indicating the approval of the new site. You will not be able to begin your study at the new site until you have this new approval letter and a fully executed TAHSN BoR agreement.
Q: I am a Site Principal Investigator and was just informed by the Lead Applicant that our site is approved. They provided me with the Lead-REB-approved consent form – what changes can I make to the consent form?
A: As the Site Principal Investigator, only administrative changes can be made to the already approved consent form. Administrative changes can ONLY include centre specific logos, contact information and letter head.
Q: I am the Site Principal Investigator and have experienced a Reportable Event at our site. Do I submit to the Lead REB or does the Lead Applicant submit on my behalf?
A: You are responsible for submitting all local Reportable Events, privacy breaches, and protocol deviations to the Lead REB. The Lead Applicant is responsible for submitting amendments, revised consents, external and non-local Reportable Events, the Investigational Brochure and product monographs while you are responsible for the site-specific documents not previously submitted.
Q: As the Lead Applicant, am I responsible for submitting all material to be approved to the Lead REB on behalf of the sites for the duration of the study? Or do my responsibilities end after the initial Lead REB Approval/ TAHSN BoR Agreement?
A: As the Lead Applicant, you are responsible for submitting all study amendments, revised consents, changes to the Investigational Brochure, DSMB reports, etc. on behalf of all participating sites.
- Glossary of Terms
Individual(s) authorized to sign documents on behalf of an institution or organization.
The primary Principal Investigator (PI) or the designated PI responsible for submitting the study to the Toronto Academic Health Sciences Network (TAHSN) Board of Record on behalf of all TAHSN sites involved in the study.
See Lead REB.
The research ethics board (REB) that has been granted the ultimate authority for the ethics review and oversight of a research study.
The Navigator facilitates and provides guidance to all study teams, including the Lead Applicant and Lead PI, applying to and using the TAHSN Board of Record model for obtaining ethics approval for research studies involving human participants. He/she also provides guidance to the Site Navigators and Lead REBs involved in the process. The Navigator is also the keeper of TAHSN Board of Record documents including but not limited to the TAHSN Board of Record Agreements, Lead REB Approval letters, institution qualification reports, SOPs, etc.
Research Ethics Board (REB)
A body of researchers, community members and others with specific expertise (eg, in ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all research involving humans conducted within the institution’s jurisdiction or under its auspices. (TCPS2)
The Site is the institution where the Site PI has appointment and where the Site PI will be conducting his/her research.
The Site Navigator is a designated individual from an institution who has membership with the TAHSN. This individual may provide guidance on the TAHSN Board of Record or site-specific regulatory requirements to research teams belonging to their institution.
Site Principal Investigator (PI)
The leader of the research team at a designated site. This leader is responsible for the conduct of the research and for the actions of any research member of the research team.