Submission Process and Requirements

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).

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: TCPS2 Tutorial. 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.

Please ensure that the following documents are ready before logging onto eRAP: 

1. Protocol (Please see Protocol Requirements);
2. Study instruments, questionnaires, recruitment ads, etc.;
3. Consent Form(s) (Please consult Guidelines on Consent Forms and  Genetic Research and DNA Banking Consent Forms);
4. Scientific Review Form, see above;
5. Cover letter containing a lay summary of the protocol;
6. Department Head Signature;
7. Summary of the budget, if applicable;
8. Approval letters from the appropriate departments if McGill-affiliated hospital facilities are to be used;

Studies that involve the use of investigational drugs or medical devices must include:

1. Investigator's Brochure or Product Monograph;
2. Health Canada NOL - No Objection Letter;
3. Sponsor contact information for invoicing purposes.

NOTE: 

• Consent forms are required in text format.  All other documents should be uploaded as one (1) PDF document.  

• All forms must be signed off by the McGill Principal Investigator either signing off directly in eRAP, or by attaching the completed PI Assurance Statement

• 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.

• Before submitting on eRAP, remember to SAVE and LOCK the form.

Protocol Amendments, document or consent form modifications:

On eRAP, click on Create New Amendment or Amendment Legacy; complete the form and attach any revised documents.

Annual Study Renewal:

On eRAP, click on Create New Continuing Review and complete the form well in advance of the study’s ethics oversight expiry date.

Study Termination:

On eRAP, click on Create New Termination and complete the form and attach copies of the study abstract if the results were published or presented at a meeting.

Study Adverse or Unanticipated Events (SAUE) reporting, protocol deviations:

On eRAP, click on Create New Reportable New Information and complete the Protocol Deviation or Unanticipated Issue Form.

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 McGill 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 McGill IRB submit2irb.med [at] mcgill.ca.

NOTE:

Investigators must report planned changes in the conduct of previously approved research. Although minor changes proposed to the study may be reviewed in an expedited manner, changes deemed not to be minor by the Chair, require full board approval before the change may be implemented. The only exception is the rare circumstance where a change is necessary to eliminate an immediate hazard to the participant. Unanticipated risks to participants or new information that may affect the risk/benefit assessment must be reported promptly. Continuing review of research involving human participants must be carried out at intervals appropriate to the degree of risk but not less than once per year from the date of initial IRB approval. The investigator should contact the McGill IRB to determine the requirements for continuing review. Continuing review may require modification of the written consent.

Any researcher and student (graduate, postdoctoral) that has a McGill username and password can use the portal. Most McGill faculty and students are already entered in the system. If you cannot log in, please contact erapsupport [at] mcgill.ca 

PIs can designate students or staff of their research team to work on the submission. Because staff are not automatically in the system, the faculty PI may have to contact eRAP support requesting system access. 

External researchers cannot use eRAP. 

For medical students, the supervisor must create the ethics application and submit it.

You can start using eRAP now for all categories of submissions and you are encouraged to do so.  As of April 1, 2022, all submissions must be done using the eRAP system. 

Download and consult the User Guide

Ensure that you have all your documents ready for your initial submission: protocol, consent form, study tools/instruments, scientific review form, department head assurance form, PI Assurance statement (if you are not the PI); for all other submissions, ensure that you have any supporting documents ready.  Consult the Submission Procedures page for the list of documents required. 

There are 2 options for amendments called Amendment and Amendment - Legacy.

You MUST select the Amendment - Legacy form if your original ethics application was reviewed prior to the launching of the new eRAP submission system.