Multicentre Studies

Process for the evaluation of multicenter projects at the MUHC

In light of the new regulatory framework  (the Cadre de référence des établissements publics du réseau de la santé et des services sociaux pour l’autorisation d’une recherche menée dans plus d’un établissement)  particular regulations apply to research taking place in more than one public institution within Quebec‘s health and social services network (reseau de santé et services sociaux - RSSS).

Since February 1, 2015:

  • Any research project taking place in more than one public institution within the RSSS, undergoes only one ethics review and approval by a designated reviewing REB from within the RSSS.  This review will be recognized by all institutions within the RSSS where the research will take place.
  • An institutional feasibility review must be done at each participating institution.
  • An authorization to conduct the research must be obtained from each participating institution before any research procedures are carried out at that site.  This authorization is granted by the “person mandated by the institution to authorize research“  (hereafter PM), at the investigator‘s institution.

The MUHC REB

The MUHC REB is a committee designated by the Minister of Health and Social Services of Quebec; therefore it is authorized to act as a reviewing REB (rREB) for multicenter research projects. 

The person mandated by the MUHC

The PM ensures that a local review of the feasibility of the project is carried out and authorizes all studies at the MUHC.  Me. Marie Hirtle has been named PM by the MUHC Board of Directors.

Useful links provided by the Quebec government and available in French only

Instructions on how to submit an MP project in Nagano

Step by step tables: multicenter process 

Forms

Initial project submission in Nagano

A Nagano submission form (F11) must be used by MUHC investigators for the submission of any research project to the REB of the MUHC.  The F11 will begin both the local feasibility and the ethics (if applicable) review of the project. 

Ongoing Reviews 

-Nagano forms must be used to submit all ongoing review requests to the MUHC REB.

-If an external site must report a local event to the rREB for ongoing review, the external investigator will not have access to Nagano.  They must complete the relevant pdf form below (equivalent to Nagano forms).

The pdf forms for external sites are available by clicking on the links here:

The MUHC investigator must upload the pdf form that has been completed and signed by the external site investigator into the appropriate Nagano form.  All pdf forms must be uploaded into an F2MP Nagano form EXCEPT annual renewals (F9) and the closure of a research site (F10MP) or the closure of a research project (F10).  Please find below the correspondence between the Nagano form and the pdf version:

Use F9 Nagano -->upload F9PDF from external site

Use F10MP or F10 Nagano -->upload F10PDF from external site

Use F2MP Nagano -->Upload any and all other pdf forms (F1PDF, F2PDF, F3aPDF, F3bPDF) from the external site.

Instructions : How to submit an externally evaluated multicenter project in Nagano-  MEO

Communication and document pathway – MEO projects i.e. (MUHC≠rREB):

Step by step tables: Externally evaluated multicenter process:

Forms

Initial submission of project in Nagano

The Nagano submission form (F11MEO) must be used by MUHC investigators to submit all externally evaluated research projects in order to commence the institutional feasiblity review and obtain MUHC authorization to conduct the research.

Ongoing Reviews

All ongoing reviews must be submitted to the MUHC’s person mandated… following the external REB’s approval. However, if the reportable event entails a risk to the safety and well-being of MUHC participants, the report must be submitted to the person mandated at the MUHC as soon as possible, without waiting for the approval of the external reviewing REB.

The annual renewal of the ethics approval by the external reviewing REB must be submitted to Nagano using the F9MEO form in order to obtain the annual renewal of the MUHC authorization by the PM of the MUHC. 

For multicenter projects evaluated by an external reviewing REB, the following Nagano forms are used for ongoing review:

  • Use an F9MEO --> to submit notification of the external REB’s annual renewal approval
  • Use an F2MEO --> to submit notification of any other external REB approvals