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Research Ethics Board

Forms

Submission Checklist (35 KB doc 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 Hospital Research Ethics Board.

TAHSC Application Form (294 KB doc file)
The Toronto Academic Health Sciences Committee (TAHSC) Human Subjects Research Application form is the primary application form for submitting a study for review to the St. Michael's Hospital Research Ethics Board.

PHIPA Appendix (125 KB doc file)
This addendum document highlights privacy concerns that researchers must address prior to starting their study, to meet regulatory requirements as described in the Personal Health Information Protection Act (PHIPA) of Ontario.

Annual/Interval Review or Study Closure Form (147 KB doc file)
In accordance with REB and national ethical guidelines, approved studies must be renewed quarterly, semi-annually or annually. The annual/interval 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.

For study termination, the annual/interval review form should also be completed and submitted to the REB. When using the form, you may indicate in the study status area that the study is to be closed. 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 Hospital 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 Hospital 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.