TAHSN Board of Record

TAHSN Board of Records
About TAHSN BOR

The Toronto Academic Health Sciences Network (TAHSN) Board of Record allows TAHSN academic hospitals to defer Research Ethics oversight to a single TAHSN member REB (“Lead REB”) for studies that involve two or more TAHSN institutions. With this process, one hospital can accept the research ethics review of a qualified REB at another TAHSN institution.
 
The TAHSN Board of Record model is efficient because only one investigator ("Lead Applicant") is required to submit the application and apply for ethical approval from the Lead's Research Ethics Board (Lead REB). In essence, they are submitting to the TAHSN Board of Record on behalf of all participating TAHSN sites. However, The Site PI’s are required to submit a modified/abbreviated application.
 
The BoR process does not relieve the site PI’s from their responsibility of notifying the REB of record of all site specific revisions, amendments, new information, unanticipated events (i.e. SAE’s, deviations, privacy breaches) etc. Please find applicable submission forms on the “Resources: Forms” section of this website.

If you have any questions, please contact the TAHSN Board of Record Navigator at tahsnbor@uhnresearch.ca
 
A list of participating institutions are below:


BoR Supporting Content List
  • Submit a Study to the TAHSN BoR

    How to request a TAHSN Board of Record (BoR) review:

    1. The Lead Applicant is to request a TAHSN BoR review by completing and submitting the Request Form and the Site Specific Form to the Navigator. All requests to use the TAHSN BoR must also include the study protocol, consent form template(s) and any other applicable documents.
    2. The Navigator will inform you if your request has been accepted or if your study is ineligible.

    If accepted, the Lead Applicant must:
    1.  submit the study to the applicable Lead REB on behalf of all Site Investigators for ethical review.
      • ensure that each Site PI will satisfy any site-specific requirements before starting study-related activities at their site. 
    2.  facilitate signatures for the TAHSN Board of Record Study Agreement(s) (one per each site) as per the Navigator's instructions. 
    Note: These forms may only be accessible for download through some browsers. If your browser does not open the form, please right-click on the hyperlink and click save-as to open and save the form. If this does not work, please contact the Navigator for a copy.

    Click here to download the general instructions for the TAHSN Board of Record.
  • Determining if a Study is Eligible

    Inclusion:

    • Multi-site study with 2+ TAHSN institutions
    • Participating sites must all be TAHSN BoR qualified (see "Determinig if/when your REB has been Approved by another Institution" below)
    • Investigator-sponsored studies - find more information on sponsored studies below
    • Any study that is minimal risk as defined by the TCPS2
     

    Exclusion:

    • Any non-TAHSN institutions
    • Non-qualified TAHSN institutions
    • REB-approved studies if the Lead REB's qualification was not accepted by each TAHSN institution involved prior to the initial approval

    • Industry-sponsored studies - find more information on sponsored studies below
    • Any study greater than minimal risk according to the TCPS2


    The sponsor is the person who takes responsibility for and initiates a clinical research study. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. The sponsor may be an individual, such as the Principal Investigator, OR an industry or commercially sponsored study such as a pharmaceutical company or governmental agency.

  • Determining if/when your REB has been approved by Another Institution
    New and ongoing studies are NOT eligible to use the TAHSN BoR if the study received the initial REB approval before the site(s) accepted the Lead REB’s qualification.

    The table below links each TAHSN institution with the qualified REB and lists the potential date of approval and can be used to determine if your study is eligible.

    For New Study Submissions to use the TAHSN Board of Record (BOR), eligible institutions must have accepted the REB qualification. Already Approved Studies (Amendments to add eligible sites) that have received approval from an REB and intend on adding sites through the Board of Record Model can only do so using institutions that have accepted the REB qualification of the Lead REB.

    Table Legend: QR (Date) = Date when a site’s own Board of Directors approved their REB to act as a qualified TAHNS BOR. NA = Not yet approved.
    TAHSN Institution
    Qualified REBs SHSC
    UHN
    SMH
    HB
    CAMH
    Baycrest
    WCH
    MSH
    SKH

    Sunnybrook Health Sciences Centre (SHSC)

    QR 17-Oct-2013

    3-Oct-2013

    10-Dec-2013

    21-May-2014

    10-Apr-2014

    15-May-2014

    3-Dec-2014

    15-Dec-2016

    2-Mar-2016
    University Health Network (UHN)
       17-Oct-2013
    QR 3-Oct-2013

    10-Dec-2013

    21-May-2014

    10-Apr-2014

    15-May-2014

    3-Dec-2014

    15-Dec-2016

    18-Jun-2014
    St. Michael’s Hospital (SMH)

    5-Feb-2014

    6-Feb-2014
    QR 10-Dec-2013

    21-May-2014

    10-Apr-2014

    15-May-2014

    3-Dec-2014

    15-Dec-2016

    18-Jun-2014
    Holland Bloorview (HB)

    5-Feb-2014

    7-Nov-2013

    10-Dec-2013
    QR 3-Nov-2013

    10-Apr-2014

    15-May-2014

    NA

    15-Dec-2016

    3-Mar-2014
    Centre for Addiction and Mental Health (CAMH)

    16-Jun-2014

    5-Jun-2014

    10-Jun-2014

    21-May-2014
    QR 10-Apr-2014

    15-May-2014

    3-Dec-2014

    15-Dec-2016

    2-Mar-2016
    Baycrest Centre for Geriatric Care (Baycrest)

    16-Jun-2014

    5-Jun-2014

    10-Jun-2014

    21-May-2014

    26-March-2015
    QR 15-May-2014

    NA

    15-Dec-2016

    2-Mar-2016
    Women’s College Hospital (WCH)

    15-Apr-2015

    NA

    14-Apr-2015

    21-May-2014

    26-March-2015

    21-Nov-2016
    QR 3-Dec-2014

    15-Dec-2016

    2-Mar-2016
    Mount Sinai Hospital (MSH)

    NA

    NA

    NA

    NA

    NA

    NA

    NA
    15-Dec-2016
    2-Mar-2016
    Sick Kids Hospital  (SKH)

    NA

    NA

    13-Dec-2016

    21-Apr-2015

    NA

    21-Nov-2016

    NA

    15-Dec-2016
    2-Mar-2016

     

     

     




    For more information, please contact the TAHSN BOR Navigator

     

  • 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 Susan Pilon, 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 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,

    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

     


     

  • 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.


    Consent Form:


    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.


    REB Submissions:


    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.

  • 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
  • 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 the 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.
  • Glossary of Terms

    Authorized Signatory

    Individual(s) authorized to sign documents on behalf of an institution or organization.

    Lead Applicant

    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.

    Lead

    See Lead REB.

    Lead REB

    The research ethics board (REB) that has been granted the ultimate authority for the ethics review and oversight of a research study.

    Navigator

    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)

    Site

    The Site is the institution where the Site PI has appointment and where the Site PI will be conducting his/her research.

    Site Navigator

    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.

  • TAHSN Board of Record Contact

    Melissa Lanuza, TAHSN Board of Record Navigator
    416-581-8590
    tahsnbor@uhnresearch.ca 

The Toronto Academic Health Sciences Network (TAHSN) Board of Record allows TAHSN academic hospitals to defer Research Ethics oversight to a single TAHSN member REB (“Lead REB”) for studies that involve two or more TAHSN institutions. With this process, one hospital can accept the research ethics review of a qualified REB at another TAHSN institution.
 
The TAHSN Board of Record model is efficient because only one investigator ("Lead Applicant") is required to submit the application and apply for ethical approval from the Lead's Research Ethics Board (Lead REB). In essence, they are submitting to the TAHSN Board of Record on behalf of all participating TAHSN sites. However, The Site PI’s are required to submit a modified/abbreviated application.
 
The BoR process does not relieve the site PI’s from their responsibility of notifying the REB of record of all site specific revisions, amendments, new information, unanticipated events (i.e. SAE’s, deviations, privacy breaches) etc. Please find applicable submission forms on the “Resources: Forms” section of this website.

If you have any questions, please contact the TAHSN Board of Record Navigator at tahsnbor@uhnresearch.ca
 
A list of participating institutions are below:


Submit a Study to the TAHSN BoR

How to request a TAHSN Board of Record (BoR) review:

  1. The Lead Applicant is to request a TAHSN BoR review by completing and submitting the Request Form and the Site Specific Form to the Navigator. All requests to use the TAHSN BoR must also include the study protocol, consent form template(s) and any other applicable documents.
  2. The Navigator will inform you if your request has been accepted or if your study is ineligible.

If accepted, the Lead Applicant must:
  1.  submit the study to the applicable Lead REB on behalf of all Site Investigators for ethical review.
    • ensure that each Site PI will satisfy any site-specific requirements before starting study-related activities at their site. 
  2.  facilitate signatures for the TAHSN Board of Record Study Agreement(s) (one per each site) as per the Navigator's instructions. 
Note: These forms may only be accessible for download through some browsers. If your browser does not open the form, please right-click on the hyperlink and click save-as to open and save the form. If this does not work, please contact the Navigator for a copy.

Click here to download the general instructions for the TAHSN Board of Record.
Determining if a Study is Eligible

Inclusion:

  • Multi-site study with 2+ TAHSN institutions
  • Participating sites must all be TAHSN BoR qualified (see "Determinig if/when your REB has been Approved by another Institution" below)
  • Investigator-sponsored studies - find more information on sponsored studies below
  • Any study that is minimal risk as defined by the TCPS2
 

Exclusion:

  • Any non-TAHSN institutions
  • Non-qualified TAHSN institutions
  • REB-approved studies if the Lead REB's qualification was not accepted by each TAHSN institution involved prior to the initial approval

  • Industry-sponsored studies - find more information on sponsored studies below
  • Any study greater than minimal risk according to the TCPS2


The sponsor is the person who takes responsibility for and initiates a clinical research study. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. The sponsor may be an individual, such as the Principal Investigator, OR an industry or commercially sponsored study such as a pharmaceutical company or governmental agency.

Determining if/when your REB has been approved by Another Institution
New and ongoing studies are NOT eligible to use the TAHSN BoR if the study received the initial REB approval before the site(s) accepted the Lead REB’s qualification.

The table below links each TAHSN institution with the qualified REB and lists the potential date of approval and can be used to determine if your study is eligible.

For New Study Submissions to use the TAHSN Board of Record (BOR), eligible institutions must have accepted the REB qualification. Already Approved Studies (Amendments to add eligible sites) that have received approval from an REB and intend on adding sites through the Board of Record Model can only do so using institutions that have accepted the REB qualification of the Lead REB.

Table Legend: QR (Date) = Date when a site’s own Board of Directors approved their REB to act as a qualified TAHNS BOR. NA = Not yet approved.
TAHSN Institution
Qualified REBs SHSC
UHN
SMH
HB
CAMH
Baycrest
WCH
MSH
SKH

Sunnybrook Health Sciences Centre (SHSC)

QR 17-Oct-2013

3-Oct-2013

10-Dec-2013

21-May-2014

10-Apr-2014

15-May-2014

3-Dec-2014

15-Dec-2016

2-Mar-2016
University Health Network (UHN)
   17-Oct-2013
QR 3-Oct-2013

10-Dec-2013

21-May-2014

10-Apr-2014

15-May-2014

3-Dec-2014

15-Dec-2016

18-Jun-2014
St. Michael’s Hospital (SMH)

5-Feb-2014

6-Feb-2014
QR 10-Dec-2013

21-May-2014

10-Apr-2014

15-May-2014

3-Dec-2014

15-Dec-2016

18-Jun-2014
Holland Bloorview (HB)

5-Feb-2014

7-Nov-2013

10-Dec-2013
QR 3-Nov-2013

10-Apr-2014

15-May-2014

NA

15-Dec-2016

3-Mar-2014
Centre for Addiction and Mental Health (CAMH)

16-Jun-2014

5-Jun-2014

10-Jun-2014

21-May-2014
QR 10-Apr-2014

15-May-2014

3-Dec-2014

15-Dec-2016

2-Mar-2016
Baycrest Centre for Geriatric Care (Baycrest)

16-Jun-2014

5-Jun-2014

10-Jun-2014

21-May-2014

26-March-2015
QR 15-May-2014

NA

15-Dec-2016

2-Mar-2016
Women’s College Hospital (WCH)

15-Apr-2015

NA

14-Apr-2015

21-May-2014

26-March-2015

21-Nov-2016
QR 3-Dec-2014

15-Dec-2016

2-Mar-2016
Mount Sinai Hospital (MSH)

NA

NA

NA

NA

NA

NA

NA
15-Dec-2016
2-Mar-2016
Sick Kids Hospital  (SKH)

NA

NA

13-Dec-2016

21-Apr-2015

NA

21-Nov-2016

NA

15-Dec-2016
2-Mar-2016

 

 

 




For more information, please contact the TAHSN BOR Navigator

 

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 Susan Pilon, 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 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,

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

 


 

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.


Consent Form:


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.


REB Submissions:


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.

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
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 the 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.
Glossary of Terms

Authorized Signatory

Individual(s) authorized to sign documents on behalf of an institution or organization.

Lead Applicant

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.

Lead

See Lead REB.

Lead REB

The research ethics board (REB) that has been granted the ultimate authority for the ethics review and oversight of a research study.

Navigator

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)

Site

The Site is the institution where the Site PI has appointment and where the Site PI will be conducting his/her research.

Site Navigator

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.

TAHSN Board of Record Contact

Melissa Lanuza, TAHSN Board of Record Navigator
416-581-8590
tahsnbor@uhnresearch.ca