REB Templates and Guidelines

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  • Use the “All Templates and Guidelines” tab to view all available templates and guidelines
  • Click on a subject tab to explore the available templates and guidelines for that subject

TEMPLATES
Consent form checklist
Utilize this checklist prior to submitting a consent form to the REB.November 05, 2013
Consent form template and guidelinesThe consent form provided to research participants must provide all the information needed to make an informed decision about taking part in the research. This document provides a template for and detailed guidance on how to write a consent form.March 01, 2021
Consent summary template and guidelinesA Consent Summary is required for any study that receives US Federal funds. It can also be used in other studies if the researchers feel that it will be helpful to their participants.March 01, 2021
Protocol deviations log
Use this log to submit a summary of all protocol deviations to the Research Ethics Board only if required by the study sponsor (also see Guidelines for reporting protocol deviations) June 08, 2018
QUICK REFERENCE TOOLS
Investigator Signature Requirements
Outlines the requirements for the investigator signature on all submissions to the Research Ethics Board (REB). June 08, 2018
Reporting serious adverse events (SAEs) / unanticipated problems (UPs) to the REB
A quick reference tool that can be used to help determine which Adverse Events (AEs) and Unanticipated Problems (UPs), both internal and external, need to be reported to the REB.June 08, 2018
Serious adverse event (SAE) / unanticipated problem (UP) reporting timelines
A quick reference on the timelines for reporting Serious Adverse Events (SAEs) and Unanticipated Problems (UPs) to the REB.June 08, 2018
GUIDELINES
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 Research Ethics Board.March 12, 2019
Guidelines for reporting protocol deviations
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 Research Ethics Board.June 08, 2018
Privacy & Security Guideline: Email Communication in ResearchThis document explains the required privacy & security controls that must be in place for communicating with research participants via email.April 2019
Privacy & Security Guideline: Texting in ResearchThis document explains the required privacy & security controls that must be in place for using text messaging in research.April 30, 2019
Privacy & Security Guideline: Survey Tools in Research
This document explains the required privacy & security controls that must be in place for research using online survey tools.October 2020
Privacy & Security Guideline: Audio Recording in ResearchThis document explains the required privacy & security controls that must be in place for using audio recording in research.December 18, 2020
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
Safety & Crisis Planning Document & Guidelines For Research Staff, Managers and Principal Investigators
The aim of this document is to provide guidelines to safely manage any challenging scenarios in a responsible, respectful and confidential manner.
These guidelines were developed and written by research staff working at The Upstream Lab, Centre for Urban Health Solutions, St. Michael’s Hospital in consultation with the Research Ethics Board. This document is intended to serve as an on-hand reference to research staff, in the interests of protecting study participants and research staff.
December 21, 2017
Preparing Interviewers and Research Participants for a Safe InterviewThe aim of this document is to provide tips on planning and implementing safety protocols increases the likelihood of having a safe and positive research interview.
These guidelines were developed and written by research staff working at Survey Research Unit, Centre for Urban Health Solutions, St. Michael’s Hospital in consultation with the Research Ethics Office.
2017
Guidance document for reviewing clinical trials in diabetes

This document provides guidance for members of the Research Ethics Board 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

Investigator Signature Requirements – June 08, 2018
Outlines the requirements for the investigator signature on all submissions to the Research Ethics Board (REB).

Guidance document for reviewing clinical trials in diabetes – November 04, 2010
This document provides guidance for members of the Research Ethics Board 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.

  • Consent form checklist – November 05, 2013 Utilize this checklist prior to submitting a consent form to the REB.
  • Consent form template and guidelines – March 01, 2021  The consent form provided to research participants must provide all the information needed to make an informed decision about taking part in the research. This document provides a template for and detailed guidance on how to write a consent form.
  • Consent summary template and guidelines – March 01, 2021 A Consent Summary is required for any study that receives US Federal funds. It can also be used in other studies if the researchers feel that it will be helpful to their participants.
  • Guidelines for signatures on consent forms – June 05, 2002 This guideline document provides examples and discussion on the types of signature recommended in consent documents.

Quick Reference – Reporting serious adverse events (SAEs) / unanticipated problems (UPs) to the REB – June 08, 2018
A quick reference tool that can be used to help determine which Adverse Events (AEs) and Unanticipated Problems (UPs), both internal and external, need to be reported to the REB.

Quick Reference – Serious adverse event (SAE) / unanticipated problem (UP) reporting timelines – June 08, 2018
A quick reference on the timelines for reporting Serious Adverse Events (SAEs) and Unanticipated Problems (UPs) to the REB.

Guidelines for reporting serious adverse events / unanticipated problems – March 12, 2019
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 Research Ethics Board.

Guidelines for reporting protocol deviations – June 08, 2018
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 Research Ethics Board.

Protocol deviations log – June 08, 2018
Use this log to submit a summary of all protocol deviations to the Research Ethics Board only if required by the study sponsor.

Privacy & Security Guideline: Audio Recording – December 2020
This document explains the required privacy & security controls that must be in place for research using audio recording in research.

Privacy & Security Guideline: Email Communication in Research – April 2019
This document explains the required privacy & security controls that must be in place for communicating with research participants via email.

Privacy & Security Guideline: Survey Tools in Research – October 2020
This document explains the required privacy & security controls that must be in place for research using online survey tools.

Privacy & Security Guideline: Texting in Research – April 30, 2019
This document explains the required privacy & security controls that must be in place for using text messaging in research.

Safety & Crisis Planning Document & Guidelines For Research Staff, Managers and Principal Investigators – December 21, 2017
The aim of this document is to provide guidelines to safely manage any challenging scenarios in a responsible, respectful and confidential manner.
These guidelines were developed and written by research staff working at The Upstream Lab, Centre for Urban Health Solutions, St. Michael’s Hospital in consultation with the Research Ethics Board. This document is intended to serve as an on-hand reference to research staff, in the interests of protecting study participants and research staff.

Preparing Interviewers and Research Participants for a Safe Interview – 2017
The aim of this document is to provide tips on planning and implementing safety protocols increases the likelihood of having a safe and positive research interview.
These guidelines were developed and written by research staff working at Survey Research Unit, Centre for Urban Health Solutions, St. Michael’s Hospital in consultation with the Research Ethics Office.

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