Colleagues,
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: tahsnbor@uhnresearch.ca
Clinical Trials Ontario: streamline@ctontario.ca
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
- Information on Transitioning Studies from the TAHSN Board of Record to CTO
As you know, your study will be transitioning from the TAHSN Board of Record (BoR) model to Clinical Trials Ontario (CTO). Below is information explaining what to expect throughout the transition process and how to proceed after the study has successfully transitioned.
Who will be transitioning my study?
We have established a joint TAHSN Board of Record/CTO team to make this transition as seamless and effortless for you as possible. The TAHSN Site Navigator at your site will be contacting you directly regarding your studies.
How is my study being transitioned?
Upon successful transition, there will be a detailed Note to File in the Correspondence section associated with the Provincial and Centre applications so all members of the study team have access to it. This Note to File details the procedures taken to migrate study details and associated documents in CTO Stream.
Will I have any actions to complete during the transition?
The study is being transferred to the CTO system on your behalf and the transfer to CTO does not affect the status of the study. You will not have any actions to complete, however you will receive auto notifications from the CTO system at certain points throughout the process. Upon successful transition, the person identified as the Main Study Contact (usually the person who will be completing the Provincial submissions) will be required to accept the project ownership via CTO Stream. In addition to receiving an email notification from CTO Stream, the TAHSN Board of Record Navigator will personally reach out to this person once the transfer request has been sent.
Who will be the REB of Record for my study moving forward?
Moving forward (after the transfer is complete), your study’s ethical oversight will remain with the same REB of Record but you will be responsible for submitting on-going submissions through the CTO Stream system. The existing approval/expiry dates will not be impacted as a result of the transfer.
Where can I find information on CTO Stream?
There are weekly webinars hosted by CTO and QuickGuides to learn more about the CTO system. They can be accessed here:
http://www.ctontario.ca/streamlined-research-ethics-review-system/cto-stream/cto-stream-overview/
CTO Stream TAHSN Board of Record https://apply.ctostream.ca 1-877-715-2700 416-634-8590 streamline@ctontario.ca tahsnbor@uhnresearch.ca - 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 tahsnbor@uhnresearch.ca.
- 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
Suite 8-600
Toronto, ON M5G 1Z5SickKids Hospital 416-813-8279 David Kenney, 416-813-7654 ext. 205718 Research Ethics Board Main Office
Room 5515, Hill Wing555 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. 88144Research Ethics, Human Research Protections Program, SRI
2075 Bayview Avenue, Room C8 19
Toronto, ON M4N3M5
University Health Network 416-581-7849 Anita Sengar, 416-581-7546
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. - TAHSN Board of Record Contact
Melissa Lanuza, TAHSN Board of Record Navigator
416-581-8590
tahsnbor@uhnresearch.ca