Revised Draft 2^nd Edition of the TCPS (December 2009)

Notice: TCPS 2 has replaced all previous versions of the Policy as the official human research ethics policy of the Agencies.

Revised Draft 2nd Edition - Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2009)

Companion Documents

The following PDF documents highlighted the proposed changes to the TCPS:

Highlights of Changes

Table of Concordance (PDF, 819 KB)

Table of Contents

• Introduction
  • Mandate of the Agencies
  • Compliance with the Policy
• Chapter 1
  • ETHICS FRAMEWORK
    • A. The Importance of Research and Research Ethics
    • B. Core Principles
    • C. How to Apply this Policy
• Chapter 2
  • SCOPE AND APPROACH
    • A. Scope of Ethics Review
    • B. Approach to REB Review
• Chapter 3
  • CONSENT
    • A. General Principles
    • B. Departures from General Principles of Consent
    • C. Capacity
    • D. Consent Shall Be Documented
• Chapter 4
  • FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
    • A. Introduction
    • B. Appropriate Inclusion
    • C. Inappropriate Exclusion
    • D. Inappropriate Inclusion
• Chapter 5
  • PRIVACY AND CONFIDENTIALITY
    • A. Key Definitions and Principles
    • B. The Ethical Duty of Confidentiality
    • C. Safeguarding Information
    • D. Consent and Secondary Use of Identifiable Information for Research Purposes
    • E. Data Linkage
• Chapter 6
  • GOVERNANCE OF RESEARCH ETHICS REVIEW
    • A. Establishment of REBs
    • B. Procedures for REB Review
    • C. Reconsideration and Appeals
    • D. Research Ethics Review During Publicly Declared Emergencies
• Chapter 7
  • CONFLICT OF INTERESTS
    • A. Institutions and Conflicts of Interests
    • B. REB Members and Conflicts of Interests
    • C. Researchers and Conflicts of Interests
• Chapter 8
  • MULTI-JURISDICTIONAL RESEARCH
    • A. Review Mechanisms for Research Involving Multiple Institut and/or Multiple REBs
    • B. Review of Research Conducted Outside an REB’s Jurisdiction
• Chapter 9
  • RESEARCH INVOLVING ABORIGINAL PEOPLES IN CANADA
  • Introduction
    • A. Key Concepts and Definitions
    • B. Interpreting the Ethics Framework in Aboriginal Contexts
    • C. Applying Provisions of this Policy in Aboriginal Contexts
• Chapter 10
  • QUALITATIVE RESEARCH
    • A. The Nature of Qualitative Research
    • B. Research Ethics Review of Qualitative Research
• Chapter 11
  • CLINICAL TRIALS
    • A. Overview
    • B. Assessing Safety and Minimizing Risk
    • C. Phases of Clinical Trials
    • D. Sharing New Information
    • E. Therapeutic Misconception
    • F. Financial Conflicts of Interests
    • G. Placebo-Controlled Studies
    • H. Analysis and Dissemination of the Data and Results of Clinical Trials
• Chapter 12
  • HUMAN BIOLOGICAL MATERIALS AND MATERIALS RELATED TO HUMAN REPRODUCTION
    • A. Types of Human Biological Materials
    • B. Collection of Human Biological Materials
    • C. Consent and Secondary Use of Identifiable Human Biological Materials for Research Purposes
    • D. Storage and Banking of Human Biological Materials
    • E. Research Involving Materials Related to Human Reproduction
• Chapter 13
  • HUMAN GENETIC RESEARCH
    • A. Application of Core Principles to Genetic Research
    • B. Plans for Handling Information Revealed through Genetic Research
    • C. Genetic Counselling
    • D. Genetic Research Involving Families
    • E. Genetic Research Involving Communities
    • F. Genetic Material Banks
    • G. Gene Transfer