REB Forms & Guidelines

FORMVERSION DATE
NEW SUBMISSIONS
Research Ethics Board application (full board/delegated)
Toronto Academic Health Sciences Network (TAHSN) human subjects research ethics application
October 28, 2011
Research Ethics Board application (retrospective data)
Toronto Academic Health Sciences Network (TAHSN) application to access retrospective data for research purposes
September 25, 2012
Research Ethics Board submission checklist March 30, 2017
ONGOING SUBMISSIONS
Continuing review form March 30, 2017
Amendment and administrative change request form March 30, 2017
Change in study personnel form March 30, 2017
Change in investigator form March 30, 2017
Local serious adverse events / unanticipated problem reporting form March 30, 2017
External serious adverse events / unanticipated problem reporting form March 30, 2017
Updated safety information reporting form March 30, 2017
Protocol deviation reporting form March 30, 2017
Study closure form March 30, 2017
TEMPLATES
Consent form checklist
Utilize this checklist prior to submitting a consent form to the REB
November 05, 2013
Protocol deviations log *updated

Use this log to submit a summary of all protocol deviations to the St. Michaels's Hospital Research Ethics Board only if required by the study sponsor (also see Guidelines for reporting protocol deviations)
February 12, 2016
QUICK REFERENCE TOOLS
Investigator Signature Requirements September 12, 2016
Reporting serious adverse events (SAEs) / unanticipated problems (UPs) to the SMH REB November 24, 2015
Serious adverse event (SAE) / unanticipated problem (UP) reporting timelinesJuly 09, 2014
GUIDELINES
Guidance document for reviewing clinical trials in diabetes

This document provides guidance for members of the Research Ethics Board at St. Michael’s Hospital who are reviewing clinical trials in diabetes. This guidance is intended to ensure a consistent approach in the Research Ethics Board review of such trials, and should be used by investigators when they are preparing their Research Ethics Board submissions.
November 04, 2010
Guidelines for reporting serious adverse events / unanticipated problems
This revised document provides the definition of a local and external serious adverse event and an unanticipated problem; criteria for reporting unanticipated problems and updated safety information, instructions on how to complete the appropriate form and the process and timelines for reporting unanticipated problems and safety information to the St. Michael’s Hospital Research Ethics Board.
July 09, 2014
Guidelines for reporting protocol deviations *updated

This guidance document includes a definition of a protocol deviation, the types of protocol deviations that require reporting, instructions on how to complete the protocol deviation reporting form and the process and timelines for reporting protocol deviations to the St. Michael’s Hospital Research Ethics Board.
August 09, 2016
Guidelines for writing a research consent form
The consent form provided to research participants must provide all the information needed to make an informed decision about taking part in the research. Although participants should be provided with written information about the research, a verbal explanation and the opportunity to ask questions should also be given. This document provides detailed guidance on how to write a consent form. It also assists researchers in developing a consent form consistent with current Research Ethics Board policies and procedures by providing:
-sample text
-discussion on current ethical issues
-general guidance on how to approach the consent process
September 22, 2005
Guidelines for signatures on consent forms
This guideline document provides examples and discussion on the types of signature recommended in consent documents.
June 05, 2002