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.

TCPS 2 Companion Documents

The following PDF documents offer comparisons of the 1st edition of the TCPS (1998) and TCPS 2 (2010):

International Guidelines on Clinical Research

Responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and REBs.

Catholic Health Association – Health Ethics Guide

This guide presents a reference to the fundamental values and principles used in ethical decision-making. It presents a moral vision reflecting Roman Catholic teaching on health ethics as it applies to the complex ethical issues of contemporary society. Copies of this guide are available from the SMH REB office.

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)