Before submitting, please note:
As of February 1, 2015, all clinical trials are to be reviewed at the appropriate hospital REB, following the new guidelines for Multicentre Ethics Review implemented by the Quebec Ministry of Health. (please see MSSS framework http://www.mcgill.ca/medresearch/ethics/forms )
Since the University does not adhere to the new MSSS process, an additional McGill University ethics review may be required for human subjects research conducted at the McGill affiliated hospital sites by Faculty, students, residents, postdocs and staff. Please consult with our office for information.
The Faculty of Medicine IRB is mandated to review research that is conducted on campus and, for studies that do not involve in-hospital patient recruitment, may also review research conducted on campus 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 .
If your study involves only the McGill affiliated hospital site(s), please contact the appropriate Research Ethics Board/Committee hyperlinked above.
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.
***New mandatory human research ethics training*** : As of January 15, 2016, all McGill University students (undergraduate, graduate, postdoctoral), faculty and staff engaging in human subjects research must complete human 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). To complete the online CORE tutorial go to the TCPS2 website (http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/) and create an account selecting McGill as your institution and using your McGill email address. If you are new to McGill and 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 affiliation and email address. Completion can then be verified online by the IRB. You will also be able to print a certificate of completion for your records. The tutorial is available in English and French.
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:
- Initial Review Form [.doc];
- Protocol (please see Protocol Requirements);
- Study instruments, questionnaires, recruitment ads, etc.;
- Consent Form(s) (please consult Guidelines on Consent Forms [.doc] and Genetic Research and DNA Banking Consent Forms [.doc]);
- Scientific Review Form [.doc];
- Covering letter containing an executive summary of the protocol;
- Summary of the budget, if applicable;
- Approval letters from the appropriate departments if McGill affiliated hospital facilities are being used;
- 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 one (1) paper copy of the Continuing Review Form [.pdf].
For termination of studies: submit one (1) paper copy of the Termination Report[.pdf]
For amendments and consent form modifications: submit one (1) paper copy of the Amendment Form [.pdf]; if required, you will be asked to submit other copies.
For SAE reporting, protocol deviations, etc.: submit one (1) paper copy; if required, you will be asked to submit other copies.