Submission process

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The Faculty of Medicine Institutional Review Board (McGill IRB) is mandated to review research that involves human subjects conducted by the University's faculty, students, and/or administrative and support staff.  All research involving human participants conducted at or under the auspices of McGill University must be reviewed and approved by the appropriate McGill authorized Research Ethics Board (REB).

Research involving the McGill Affiliated Hospital Sites

The McGill affiliated hospital sites are the Douglas Mental Health University Institute, the Jewish General Hospital, the St. Mary's Hospital Centre and the MUHC which comprises the Montreal Chest Institute, the Montreal Children's Hospital, the Montreal General Hospital, the Montreal Neurological Hospital and the Royal Victoria Hospital.

If your study involves one or more of the McGill affiliated hospital site(s), please contact the appropriate hospital REB for submission information. 

The McGill IRB is the designated research ethics board for the Shriner's Hospitals for Children, Montreal.

MULTI-CENTRE RESEARCH

New guidelines for multi-centre ethics review were implemented by the Ministère de la Santé et des Services sociaux (MSSS) on February 1, 2015.  Any research project that is conducted at more than one public institution in the network (Réseau de la Santé et des Services sociaux - RSSS) must be reviewed by a research ethics board in the RSSS.  Please see MSSS Framework for Multi-Centre Review for procedures: https://mcgill.ca/medresearch/ethics/forms

Since the University is not a partner to the MSSS multi-centre review process, an additional University ethics review may be required for research that involves human subjects conducted by McGill faculty, students, residents, postdocs and staff. Researchers are advised to contact the McGill IRB office to verify whether an additional ethics review is required.

INDUSTRY SPONSORED CLINICAL TRIALS

The McGill IRB charges an administrative fee of $4,000.00 for the Initial Review of Industry-Sponsored Clinical Trials and $800.00 for the Annual Review, which includes the review of all amendments received throughout the year. The appropriate contact information to submit an invoice to the Sponsor must be provided in the initial submission package. Fees are invoiced after the McGill IRB conducts an ethics review of the study, and are payable regardless of the review outcome.  Publicly funded research, investigator-initiated, and cooperative group clinical trials are exempt from the administrative fee.

SCIENTIFIC/PEER REVIEWS

Studies that have not received a scientific/peer review either by a granting agency, a cooperative group or an independent peer-review committee must receive a scientific/peer review prior to submission to the McGill IRB. The completed Scientific/Peer Review Form must accompany the submission or, in the case of an agency-reviewed study, a copy of the agency’s scientific review or reviewer’s comments. Master and Doctoral students must submit the scientific review completed and approved by their Advisory Committee (See Section 8 of the Scientific/Peer Review Form)

MANDATORY HUMAN RESEARCH ETHICS TRAINING

All McGill University faculty, students, postdocs, residents and staff who will engage in research that involves human subjects must complete research ethics training prior to submitting an application for ethics review. This requirement can be fulfilled by completing the Tri-Council Policy Statement 2 (TCPS2) Course on Research Ethics (CORE). If you have completed the MSSS or NIH tutorial, or other recognized research ethics training program, please include a copy of the certificate with the submission package.

The CORE tutorial is available in English and French on the TCPS2 website: http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/.  Create an account and select McGill University as your institution and use your McGill email address. If you have already completed the CORE tutorial with another institution, you can change your profile information to McGill University by logging onto the tutorial and modifying your Account Details to revise your institutional affiliation and email address. The McGill IRB will verify completion of your training through the CORE program, or you can include a copy of your certificate with the submission package.

NEW STUDY SUBMISSION

E-mail one (1) copy of the following to submit2irb.med [at] mcgill.ca, and submit ten (10) paper copies to the McGill IRB Office for Full Board review.  Submit one (1) paper copy only if it has been determined that your study qualifies for Expedited/Delegated review (see below):

  1. Initial Review Form
  2. Protocol (Please see Protocol Requirements);
  3. Study instruments, questionnaires, recruitment ads, etc.;
  4. Consent Form(s) (Please consult Guidelines on Consent Forms and Genetic Research and DNA Banking Consent Forms);
  5. Scientific Review Form;
  6. Cover letter containing a lay summary of the protocol;
  7. Summary of the budget, if applicable;
  8. Approval letters from the appropriate departments if McGill-affiliated hospital facilities are to be used;
  9. Studies that involve the use of investigational drugs or medical devices must include:

a) Investigator's Brochure or Product Monograph;

b) Health Canada NOL - No Objection Letter;

c) Sponsor contact information for invoicing purposes.

NOTE: 

  • Consent forms are required in text format.  All other documents should be sent electronically as one (1) PDF document.  Paper copies must be collated as a complete document.
  • All forms must be signed by the Principal Investigator (both digital or wet signatures are acceptable)
  • Only McGill email addresses will be accepted.  The Office of the IRB will not send attachments to gmail, yahoo, hotmail accounts due to the confidential nature of the studies

EXPEDITED / DELEGATED REVIEW

Studies that involve minimal risk to participants or that involve the secondary use of data or biospecimens may be eligible for an expedited/delegated review. The Office of the IRB will determine if the study qualifies for an expedited/delegated review. There are no formal deadlines to submit an application for an expedited/delegated review. If you are uncertain whether the study qualifies for an expedited/delegated review, please contact the Office of the IRB.

SUBMISSION DEADLINES

Consult submission deadline for Full Board meeting dates and their corresponding submission deadlines. Please adhere to the submission deadline to ensure a place on the corresponding meeting agenda. Full Board review of applications received after a specific deadline date may be postponed to a subsequent meeting date.

The deadline for all study amendments, modifications, consent form revisions is one (1) week before a scheduled meeting.

ONGOING STUDIES

Protocol Amendments, document or consent form modifications: Submit electronically and provide one (1) hard copy of the completed Amendment Form, and revised documents to the McGill IRB Office. You may be required to submit additional copies.

Annual Study Renewal: Email the completed and digitally signed Continuing Review Form well in advance of the study’s ethics oversight expiry date.

Study Termination: Email the completed Termination Report and a copy of the study abstract if the results were published or presented at a meeting.

Study Adverse Events (SAE) reporting, protocol deviations: Submit one (1) paper copy of the SAE Form or Protocol Deviation Form. You may be required to submit additional copies.