McGill.CA / Research and Innovation / Conducting Research / Research Involving Humans (REB) / Faculty of Medicine and Health Sciences Research Ethics Board

FMHS REB Submission Requirements

Scientific Peer Review

  • Any study that has not received a scientific or peer review from a granting agency or an independent peer review committee must be receive a scientific or peer review prior to submission to the FMHS REB.
  • 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 participants 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 Quebec MSSS Tutorial in Research Ethics, include a copy of the certificate with the submission package.)
  • The TCPS2 CORE tutorial is available in English and French on the TCPS2 website: TCPS2 Tutorial.
    • Create an account using your McGill email address and select McGill University as your institution.
    • 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 REB Office 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

The following attachments are required when submitting a new study in eRAP. These attachments can be uploaded in the eRAP eform.

  • Study Protocol;
  • Study instruments, questionnaires, recruitment materials, etc.;
  • Consent Form(s) 
  • Scientific Review Form;
  • Cover letter containing a lay summary of the protocol;
  • Department Head Signature;
  • Summary of the budget, if applicable;

For studies involving investigational drugs or medical devices, the following documents must be included with the submission:

  • Investigator's Brochure or Product Monograph;
  • Health Canada No Objection Letter (NOL)

Study Protocol Requirements

The study protocol should include, at a minimum, the following elements. The list below is intended as a guide and is not exhaustive. Additional information may be required depending on the nature, design, and complexity of the proposed study.

1. Study Purpose and Rationale

  • Clear description of the research objectives and justification for conducting the study.

2. Study Population

  • Description of the study population.
  • Inclusion criteria.
  • Exclusion criteria.

3. Sample Size

  • Proposed sample size.
  • Justification for how the sample size was determined.

4. Study Design and Methodology

  • Overall study design.
  • Detailed description of study procedures and methods.

5. Study Endpoints

  • Definition of primary and secondary endpoints, as applicable.

6. Measurements and Study Instruments

  • Description of data collection methods and instruments, including questionnaires, surveys, interview guides, case report forms, or other data collection tools.

7. Data Analysis Plan

  • Description of the statistical and/or qualitative methods that will be used to analyze the data.

8. Recruitment Procedures

  • Detailed description of participant identification, recruitment, and enrollment procedures.

9. Confidentiality and Data Protection

  • Whether participant identifiers will be linked to study data.
  • Location and method of data storage.
  • Individuals or groups who will have access to the data.
  • Duration of data retention and plans for data destruction, where applicable.

10. Ethical Considerations

  • A statement confirming that the study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki (October 2024), the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), and any other applicable ethical, legal, regulatory, or institutional requirements.
  • Confirmation that Research Ethics Board (REB) approval will be obtained before any research activities involving human participants begin.

11. References

  • Complete list of references cited in the protocol.

eRAP

All applications must be submitted using the eRAP online submission system.

Please consult the information and user guides found here.

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