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Submission process

Quarter picture of Vitruvian Man Before submitting, please note:

The Faculty of Medicine IRB is mandated to review research that takes place on campus, at the Shriners Hospital, and in more than one McGill affiliated hospital site. The McGill affiliated hospital sites are the Douglas Mental Health University Institute, the Jewish General Hospital, the MUHC (comprised of the Montreal Chest Institute, the Montreal Children's Hospital, the Montreal General Hospital, the Montreal Neurological Hospital, and the Royal Victoria Hospital) and St. Mary's Hospital Centre .

For studies that involve more than 1 McGill hospital site, following the Faculty of Medicine IRB review the investigators must obtain authorization from each affiliated hospital site.  Kindly refer to the Investigator Responsibilities for further information.  

If your study involves only 1 affiliated hospital site, please contact the appropriate Research Ethics Board/Committee hyperlinked above. 

Also, for applications that have been submitted to granting agencies, the Faculty of Medicine IRB will not review the study until confirmation of funding has been received, or assurance that the Investigator plans to proceed with the study regardless of funding.

In addition, for studies that have not been scientifically peer reviewed either by a granting agency, by a cooperative group, or by an independent peer-review committee, the IRB requires that a scientific/peer review be done prior to submitting to the IRB.  A completed Scientific/Peer Review_Form [doc] must accompany the submission.

Industry-Sponsored Clinical Trials:  The Institutional Review Board charges $4,000.00 for the initial review of industry-sponsored clinical trial protocols and $800.00 for annual renewals (which includes fees for all amendments reviewed throughout the year).  If your study is an industry-sponsored clinical trial, you must include,  in your initial submission package,  the appropriate sponsor contact information for invoicing purposes.  The non-refundable fees are for ethics review of the study and are payable regardless of the outcome of the review.  This charge does not apply to grant-sponsored, investigator initiated, or cooperative group clinical trial protocols.

SUBMISSION PROCESS 

For a new study: 

E-mail to submit2irb [dot] med [at] mcgill [dot] ca one (1) electronic copy and submit ten (10) paper copies of the following:

  1. Initial Review Form [.doc]; 
  2. Protocol (please see Protocol Requirements);
  3. Study instruments, questionaiires, recruitment ads, etc.;
  4. Consent Form(s) (please consult Guidelines on Consent Forms [.doc] and Genetic Research and DNA Banking Consent Forms [.doc]);
  5. Scientific Review Form  [.doc];
  6. Covering letter containing an executive summary of the protocol;
  7. Summary of the budget, if applicable;
  8. Approval letters from the appropriate departments if McGill affiliated hospital facilities are being used;
  9. In addition, for the studies using investigational drugs, include:  a) Investigator's brochure or Product monograph; b) Health Canada NOL; c) Sponsor contact information for invoicing purposes.

Except for the consent forms, which are required in text format, all other documents should be sent electronically as 1 (one) pdf document.

Please note that each of the 10 paper copies must be collated as a complete document. The submission deadline is usually 20 to 25 days prior to the next meeting date.

To ensure a place on the agenda and to expedite the review process, it is useful to fax a copy of the initial review form to the IRB (514-398-3870) and to follow-up with the Ethics Review Administrator prior to the full submission.

The deadline for the following other submissions is one (1) week before the scheduled meeting

For renewal of ongoing studies: submit ten (10) paper copies of the Continuing Review Form[.doc].

For termination of studies:  submit one (1) paper copy of the Termination Report[.doc].

For amendments, consent form modifications, SAE reporting, etc.: submit one (1) paper copy; if required, you will be asked to submit other copies.