Research Ethics Board
Policies & Guidelines
National Ethical Guidelines
Standards and procedures governing research involving human subjects in Canada.
TCPS 2—2nd edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans has replaced the 1st edition of the TCPS (1998) as the official human research ethics policy of the Agencies.
- Download the TCPS 2 - Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (560 KB pdf file)
TCPS 2 Companion Documents
The following PDF documents offer comparisons of the 1st edition of the TCPS (1998) and TCPS 2 (2010):
- Highlights of TCPS 2 (56 KB pdf file)
- Table of Concordance 1st Ed. 1998 to 2nd Ed. 2010 (71 KB pdf file)
- Table of Concordance 2nd Ed. 2010 to 1st Ed. 1998 (75 KB pdf file)
- The first edition of the TCPS
International Guidelines on Clinical Research
Responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and REBs.
- Download International Conference on Harmonization (ICH): Good Clinical Practices (GCP) (E6) (242 KB pdf file)
- International Conference on Harmonization (ICH): Good Clinical Practices (GCP) (E6) (external link)
Guidelines for Writing a Research Consent Form
Download Guidelines for Writing a Research Consent Form (171 KB pdf file)
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 REB policies and procedures by providing:
- sample text
- discussion on current ethical issues
- general guidance on how to approach the consent process
Guidelines for Signatures on Consent Forms
Download Signature Guidelines Form (23 KB pdf file)
This guideline document provides examples and discussion on the types of signature recommended in consent documents.
Guidance Document for Reviewing Clinical Trials in Diabetes
This document provides guidance for members of the Research Ethics Board (REB) at St. Michael’s Hospital who are reviewing clinical trials in diabetes. This guidance is intended to ensure a consistent approach in the REB review of such trials, and should be used by investigators when they are preparing their REB submissions.Download Guidance Document (93 KB pdf file)