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 Personne mandatée of the MUHC
The Personne mandatée (PM) ensures that a local review of the feasibility of the project is carried out and it authorizes all studies at the MUHC. If you have a question concerning authorization, you can contact the PM at [email protected].
Useful links provided by the Quebec government and available in French only:
- 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 - updated April 2016
- Consult a list of ethics committees within the health and social services network
- Consult the list of persons formally mandated to authorize research by institution
For more information about the evaluation process for multicenter projects involving the MUHC
Please click on one of the links below
- Projects for which the MUHC REB is the reviewing REB (rREB) – MP projects
Instructions on how to submit an MP project in Nagano
- Initial REB submission (initial MP )
- Ongoing Review - (MP not F1MP)
- Addition of a participating site to a project already approved by the MUHC REB (amendment F1MP)
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:
- F1PDF: Amendment request for external sites
- F2PDF: Other notifications from external sites
- F3aPDF: Serious, unexpected reportable event that occurred at an external site under the jurisdiction of the MUHC as reviewing REB.
- F3bPDF: Other reportable events : deviations, breech of confidetiality, complaints, that occurred at an external site.
- F9PDF: Request for annual renewal for external sites
- F10PDF: Notification of study closure, a suspension, a termination or any interruption to a research project at an external site.
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.
- Projects for which the MUHC REB IS NOT the reviewing REB – MEO projects
Instructions : How to submit an externally evaluated multicenter project in Nagano- MEO
Communication and document pathway – MEO projects i.e. (MUHC≠rREB):
- Request for authorization to conduct research at the MUHC (initial MEO submission)
- Ongoing Review (MEO monitoring)
Step by step tables: Externally evaluated multicenter process:
- Request for authorization to conduct research at the MUHC (MEO initial submission)
- Ongoing Review (MEO monitoring)
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