Research review information

IMPORTANT
APRIL 4, 2011: Launch of new electronic study review software

The RI will be launching on April 4, 2011 a new electronic study review submission to replace the current forms posted on this website (http://muhc.ca/research/page/central-research-review).
The new software is called eReview, and will be a step-by-step online application that will facilitate the study review application and subsequent status.

The Clinical Research Core Service is providing eReview training session to all interested PIs & research staff.
Here are the currently scheduled training sessions:

March 11, 2011 at 2-4pm at the MGH; Osler Amphitheater (A6 105)
March 18, 2011 at 12-2pm at the RVH; J.S.I. Browne Amphitheater (M3.01)
March 25, 2011 at 7h30-9h30am at the MCH; Forbes Cushing Amphitheater (D-182)
March 25, 2011 at 12-2pm at the Meakins Christie; Room 110
No reservation is required.

On April 4, 2011, this section of the website will be entirely modified according to the new submission process.  Please note the RI MUHC will also provide a Helpline for assistance with the eReview system.

If you have any question, you can contact us at study [dot] review [at] muhc [dot] mcgill [dot] ca.

To facilitate the transfer to the new system, we kindly ask you not to submit your study on Friday April 1, 2011.

How to Submit

MUHC Research Quebec Multicentre Research McGill Multicentre Research REB Meeting Schedule

MUHC Research

All research with human subjects proposed for conduct at the MUHC is evaluated within the research review system and begins with a scientific, ethics ethics and site specific assessment review. Please refer to the MUHC Central Intake for details on how to submit.

At the MUHC every document that will be presented to a research subject must be available in French and English versions.  This includes all research instruments such as questionnaires for screening or data collection purposes, informed consent and assent documents, subject diaries, and all supplementary information about the research study.  All documents intended for sharing with a research subject must be approved by the MUHC REB of Record prior to use in the study.

  1. Once the submission is completed electronically through the central intake mechanism, print one original of the Initial Review form and acquire the authorizing signatures required prior to submission.
  2. Plan to submit a maximum of 20 collated packages comprised of the Initial Review application form (including the signed original) plus Study Document Checklist for science and ethics reviews. Confirm with the Ethics Review Coordinator the exact number of packages required.
  3. Submit two copies of the complete grant application for a study funded by a public or private agency. If the study is funded by a peer-review agency be sure to include the document indicating favorable scientific review.
  4. Submit one Initial Review application form for each study involving human subjects, and/or use of human material, when a research grant includes multiple human studies. Each study requiring REB approval, and its consent document must be identified by a specific study title.

Quebec Multicentre Research

As of November 1, 2008, Principal Investigators involved with studies intended for conduct at four or fewer Quebec research institutions may choose to apply for ethics review locally at their own institution OR to apply for ethics review using the MSSS Multicentre Review System.

For questions concerning the process, contact sheldon [dot] levy [at] muhc [dot] mcgill.ca at 514-934-1934, local 36077

Review procedures for Quebec multicentre research vary according to the role assigned to the Investigator by the Study Sponsor. Refer to the information at the link below that describes the Investigator’s role at the MUHC:

 

McGill Multicentre Research

When research is planned for conduct at more than one McGill teaching hospital the study may be submitted for central review with the McGill Faculty of Medicine Institutional Review Board or through the Quebec Multicentre Review process.

 

 

MUHC Investigator as Coordinating Principal Investigator

How to Submit for Review

All the reviews described below are performed in parallel via the Central Intake mechanism. Please refer to the MUHC Central Intake page for more details.

Scientific Merit Review

A favorable review for scientific merit is the first step in multicentre review. A local MUHC scientific review is not required If the research proposal received favorable scientific peer review by a recognized agency or committee. The Scientific Review Director will make the determination.

When submitting through the MUHC Central Intake mechenism, please include:


OR

 

If the submission is incomplete the Central Principal Investigator (CPI) and Study Coordinator will receive by email a memo indicating what missing information is required to conduct the review.

 

Research Ethics Review

To prepare for MUHC REB review contact the Ethics Review Coordinator identified in the memo to the CPI entitled “Quebec Multicentre Review - MUHC Principal Site”. The Coordinator will reply to questions concerning the REB submission and review, and will provide the meeting date and time when the study will be reviewed.

On Day 1 the CPI will submit all study documents for review at a Full Board convened meeting of the MUHC REB with responsibility as the Main REB for the study in Quebec. Also on Day 1 the CPI will submit three (3) complete packages of study documents listed on page 1-2 of the "Formulaire de demande d’évaluation d’un projet multicentrique" (M-Éval) to all the other REBs in Quebec that will review the study.

 

Site-Specific Assessment

The other reviews, apart from science and ethics required by the Quebec Multicentre mechanism are referred to as the Site-Specific Assessment (SSA). The term used for SSA at French language institutions is “Évaluation de convenance”.

 

MUHC Investigator as Local Principal Investigator

How to Submit for Review

Scientific Merit Review

The review for scientific merit is conducted only once for all Quebec sites and submitting for review is the responsibility of the Coordinating Principal Investigator (CPI). The scientific review or the verification of existing scientific peer review is conducted according to procedures in place at the CPI’s institution.

The Local Principal Investigator will not typically receive the scientific review report. However, the report must be included in the CPI’s submission to all Research Ethics Boards (REB) reviewing the study.

 

Research Ethics Review

The CPI completely coordinates the ethics review process and the Local Principal Investigator does not participate. However, the Local Principal Investigator remains the person responsible for study conduct at the MUHC.

To determine which MUHC REB is the most appropriate to conduct the review, the CPI must contact the MUHC Research Ethics Office (REO) to permit a “pre-review” of the proposed study. The MUHC Local Principal Investigator will receive by email the memo to the CPI entitled “Quebec Multicentre Review - MUHC Local Site” to confirm the process is underway at the MUHC.

On Day 1 the CPI will submit all study documents for review to a Full Board convened meeting of the Main REB . Also on Day 1 the CPI will submit three (3) complete packages of study documents listed on page 1-2 of the Formulaire de demande d’évaluation d’un projet multicentrique (M-Éval) to the MUHC REB that will review the study.

 

Site-Specific Assessment

At the MUHC, the Local Principal Investigator is responsible to meet requirements for the other reviews, apart from science and ethics required by the Quebec Multicentre mechanism referred to as the Site-Specific Assessment (SSA). The memo to the CPI entitled “Quebec Multicentre Review - MUHC Local Site” will be emailed to the MUHC Local Principal Investigator and the Study Coordinator to provide information concerning the MUHC SSA review.

The MUHC SSA review should be submitted via the MUHC Central Intake mechanism.

 

Submission Information for Non-MUHC Investigator

How to Submit for Review

Pre-Review

When a Quebec Multicentre study is planned for conduct at the MUHC the Coordinating Principal Investigator (CPI) must contact the MUHC Research Ethics Office(REO). The REO will conduct a “pre-review” of the proposed study to determine which MUHC Research Ethics Board (REB) is the most appropriate to conduct the review.

The CPI will send an email request for Quebec Multicentre Review to newstudy [at] muhc [dot] mcgill [dot] ca. The request must include:

  • CPI’s contact information
  • CPI’s Study Coordinator
  • name of the MUHC Local Principal Investigator
  • MSSS Reference Number assigned to the study.

The following documents must be attached to the email:

 

Note:
(1) it is understood the M-Éval form may not be filled out completely
(2) do not include the documents listed on page 1-2 of the M-Éval form

 

The CPI will receive a reply email with memo entitled “Quebec Multicentre Review - MUHC Local Site” to confirm the process is underway at the MUHC.

 

Research Ethics Review

The memo to the CPI entitled “Quebec Multicentre Review - MUHC Local Site” will contain the contact information and mailing address for the REB that will review the study.

On Day 1 the MUHC REB will expect to receive from the CPI three (3) complete packages of the "Formulaire de demande d’évaluation d’un projet multicentrique" (M-Éval) with the documents listed on page 1-2 of the M-Éval form.

The REB will conduct the review respecting the deadlines set by the MSSS.

 

Site-Specific Assessment

At the MUHC, the Local Principal Investigator is responsible to arrange for the other reviews, apart from science and ethics required by the Quebec Multicentre mechanism referred to as the Site-Specific Assessment (SSA) or “Évaluation de convenance”.

The memo to the CPI entitled “Quebec Multicentre Review - MUHC Local Site” will also be emailed to the MUHC Local Principal Investigator and the Local Study Coordinator to provide information concerning the MUHC SSA review.

The decision concerning MUHC participation in the study will be forwarded in correspondence to the CPI.