Register your protocol

How to register your protocol

All research protocols carried out at St. Mary's Hospital Center must be registered in the Research Review Office.  Below are detailed instructions on how to submit your project for review and approval.  Depending on the nature of your protocol, there may be specific requirements.

Please send all documents to:

Research Review Office, H-4710
St. Mary's Hospital Center
3830 avenue Lacombe
Montreal QC H3T 1M5

or electronic documents may be submitted via email: rebecca.macdonald.chsm@ssss.gouv.qc.ca

We accept protocol submissions in English and French. / Nous acceptons les dépôts en anglais et français.

 

 Download Research Review 101 (powerpoint presentation):

 

 

TABLE OF CONTENTS:

 If you have any questions please contact the Rebecca MacDonald, Research Review Coordinator at rebecca.macdonald.chsm@ssss.gouv.qc.ca or by phone at (514) 345-3511 ext. 3698. 

Some of these forms are PDF-fillable (). 

 

Requirements for all protocols

To register your protocol in the St. Mary's Research Review Office, you must submit the following:

- A completed Form A - Research Protocol Registration Form ().  Form A must contain all the minimum signatures necessary for review.  Any forms missing signatures will be considered incomplete and the protocol will not undergo review until all signatures have been obtained. As the required signatures vary depending on the study, please contact the Research Review Office for more detailed information.

NOTE ON OBTAINING SIGNATURES: When approaching a hospital staff member or supervisor for signature, please provide a cover letter explaining the nature of the project and the reason for signature (i.e. resource approval, administrative supervisor), also include a copy of the protocol, the CVs of investigators and any other relevant information. 

- The study protocol, which should include minimum requirements as specified in Form H - Protocol Evaluation (PDF).  The investigator should use this checklist to ensure their protocol is complete.

 

Protocols involving Human Subjects: 

- If your protocol involves interviews with or observations of human subjects (e.g. patients or hospital staff), access to patients’ medical charts, nominative patient databases containing medical chart numbers or other identifiable information, or access to human specimens and blood samples, then you must ensure that your protocol addresses the criteria listed in the Form C - Human Subjects Review Summary (PDF).  You may use this form as a checklist or submit it as a separate document along with your protocol.

- All consent forms used in research protocols at St. Mary's Hospital Center must be submitted along with the Form D - Consent form checklist. The checklist must be completed and signed by the Principal Investigator.  A consent form template is available here.

 

Protocols using the MSSS multicentre mechanism:

- If your study involves more than 4 sites in the Québec Health Network (Réseau de santé et des services sociaux), then you must register your protocol as per the procedures adopted by the Ministère de la santé et des services sociaux. If you wish to add SMHC as a site using the MSSS multicentre mechanism, please submit Form A along with the M-ÉVAL  or M-AJOUT form. Please visit the official MSSS multicentre website for more details.

 

Protocols approved by the McGill Faculty of Medicine Institutional Review Board (IRB):

- If your protocol has previously received approval from the McGill IRB you are eligible to receive expedited approval from the St. Mary's Research Ethics Committee (REC).  You are required to submit the approval letter from the IRB, Form A and all relevant protocol documentation (i.e. consent forms, protocol, human subjects review summary).

- Note: protocols involving minors or incompetent adults may be subject to full committee review.

 

Protocols involving funding:

If Research funds are being held (wholly or partially) at St. Mary’s Hospital Center a detailed budget justification must be prepared, as per standard format described in the Form I - Budget Justification Template (DOC). A copy of the funding approval letter must also be submitted to the Research Review Office.

 

Protocols involving contracts:

- If your protocol involves a clinical trial agreement between private enterprise (ex. a pharmaceutical company) and St. Mary’s Hospital Center, or an inter-institutional agreement between various Hospitals, or any other type of legal contract that binds two or more parties, including St. Mary’s Hospital Center, then you must submit a copy of the latest version of the contract along with your application. Contracts must always be between the Hospital and the other party, and if applicable, the Principal Investigator.

- Research activities may not begin until the contract has received legal review and has been signed by the Director General and Chief Executive Officer of St. Mary’s Hospital. Note: there cannot be a contract between a Principal Investigator and another party.  

 

We are always trying to improve our forms.  If you have any suggestions or comments, please contact the Research Review Office at rebecca.macdonald.chsm@ssss.gouv.qc.ca or by phone at (514) 345-3511 ext. 3698.

 

To learn about post-approval requirements, click here.

 

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