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How to submit

Please find the situation that best describes your project (A, B, C, or D) and follow the submission structure.

See Submission Process Flow Charts

 

Single-site Research Projects 

A. In the case of a single-site project for the WCMH Research Ethics Committee, research documents and relevant forms must be submitted to two entities:

 

  • The appropriate REC sub-committee, according to the research axes of your project:

MBM  REC (for a medical or biomedical project that comprises Clinical Trials) or

FLP REC (for a first-line psycho-social project that does not involve clinical trial) 

  • The RRO Feasibility and Reimbursement of research Costs Program

 

See Forms and Templates and Submission Process Flow Charts

 

Multi-Site Projects

B. In the case of a multi-centric project for the WCMH Research Ethics Committee that will also take place in another establishment, research documents and relevant forms must be submitted to three entities:

 

  • The appropriate REC sub-committee, according to the research axes of your project:

MBM REC (for a medical or biomedical project that comprises Clinical Trials) or

FLP REC (for a first-line psycho-social project that does not involve clinical trial);

  • The Office of the Formally Mandated Person to authorize research (PM) at the institution where you are going to submit the project. (the project is not submitted to the WCMH PM) 
  • The RRO Feasibility and Reimbursement of research Costs Program

 

See Forms and Templates and Submission Process Flow Charts

 

C. In the case of a multi-centric project that has already been reviewed by a Research Ethics Committee other than the WCMH REC, research documents and relevant forms must be submitted to two entities:

 

  • The WCMH Office of the Formally Mandated Person to authorize research (PM)
  • The RRO Feasibility and Reimbursement of research Costs Program

 

See Forms and Templates and Submission Process Flow Charts

 

D. In the case of a project reviewed by the CRIR Research Ethics Committee (REC), research documents and relevant forms must be submitted to two entities via the research coordinator on site (CLRC or MAB-Mackay):

 

  • The WCMH Office of the Formally Mandated Person to authorize research (PM)
  • The RRO Feasibility and Reimbursement of research Costs Program

 

 

For any inquiry contact PM and see Forms and Templates and Submission Process Flow Charts

 

At the RRO, Submissions are processed one of four ways:

  • Delegated Review: Studies can be reviewed in a delegated fashion if the study does not involve more than minimal risk. The standard of minimal risk is commonly defined as follows: if potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research then the research can be regarded as within the range of minimal risk.  Delegated approval is granted by the Chair and the protocol is then presented for corroborative approval at the next Research Ethics Committee Meeting.
  • Chart Review: A retrospective Chart Review must be authorized by the Director of Professional Services according to article 19.2 de la Loi sur les services de santé et des services sociaux. When data collected for research purposed can be linked back to the participant, the authorization from the Research Ethics Office is also required.  If they study warrants approval an approval letter signed by both the Director of Professional Services and the Chief of the Research Ethics Office will be issued.
  • Full Board Review: Studies that involve risk to participants for the advancement of scientific knowledge.

 

 

Please note:

1.    All application forms are available from the main menu under "Forms and Templates".

2.    The Feasibility Form must be completed for all studies and must be submitted at the same time as the Application package

3.    For all studies that have not been reviewed by an independent peer-review, a "Scientific Review" of the protocol must also be conducted.

4.    All items listed on the checklist (last page of the full board application form) must be filled out and all required documents included. Submissions that are incomplete will not be reviewed and will be returned to sender.

5.    For full board studies, fifteen (15) collated copies of the completed Application Form and all necessary documents must be submitted to the Research Ethics Office A-925.

6.    Please email an electronic version of your research protocol at cer@jgh.mcgill.ca

 

 

Amendments to the protocol

After a protocol is approved and activated, any modifications or amendments must be submitted promptly to the Research Review Office (RRO) for review and approval prior to this modification being implemented. Some may require a full committee review for approval, particularly if the amendment is major, or if the protocol itself has been significantly changed. An example of a major amendment would be substantial changes in inclusion and exclusion criteria.

The Consent Form will have to be modified to reflect the changes, and the participant must give his or her consent. The latter amendments may be approved by the chairman in an expedited fashion.  A protocol modification form must be completed.

At times, it may not be clear as to whether an amendment requires expedited or Committee approval. A discussion with the Research Review Office (RRO) will clarify the necessary route to take.  A Full Board Protocol Modification Form must be completed for all amendments taken to the Committee.

For the most part, however, minor changes such as the requirement for one more visit to the research center by the participant, or the drawing of one extra vial of blood at a given sitting, do not require a full committee review.

 

For any questions please contact us.