Research Ethics Board

Forms

Submission Checklist (36 KB pdf file)
Use this checklist as a reference document to ensure that you have met all requirements for submitting a study to the St. Michael's Research Ethics Board.

TAHSN Application Form (2.8 MB pdf file)
The Toronto Academic Health Science Network (TAHSN) Human Subjects Research Application form is the primary application form for submitting a study for review to the St. Michael's Research Ethics Board. (Application form also available in Microsoft Word format.)

Continuing Review Form (318 KB doc file)
In accordance with REB and national ethical guidelines, approved studies must be renewed quarterly, semi-annually or annually. The continuing review form must be completed and submitted to the REB prior to the expiration date for approved projects. The form must be submitted in hard copy with original signatures.

Study Closure Form (248 KB doc file)
For study termination, the study closure review form should be completed and submitted to the REB. Please note that a closed study is defined as one where:

  • All recruitment is completed for all sites.
  • All active treatment and follow-up is completed for all sites.
  • All analyses are completed from this site.

There is no further involvement of the principal investigator at this site in any aspect of the study.

Adverse Event Notification Form (123 KB doc file)
Human subject research is subject to continuing ethics review by the REB. As described in Article 1.13 of the "Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans", the REB review of adverse events is one component of its continuing review.

Adverse event reporting is the responsibility of the St. Michael's primary investigator, who must complete the adverse event form, including information on the seriousness of the adverse event, assessing whether or not it is a direct consequence of the research intervention, and recommendations for any further action. All local serious adverse events, whether expected or not, must be reported promptly to the REB.

The St. Michael's REB's reporting requirements are based on:

  • TCPS guidelines
  • Applicable Health Canada regulations
  • ICH GCP guidelines

Adverse event reporting is required for all drug, device or natural health product (NHP) studies in Canada.