TCPS 2 (2010) —2nd edition of Tri-Council Policy Statement:
Ethical Conduct for Research Involving Humans

Video: Introducing TCPS 2 with the Tri-Council Presidents and Chair of the Panel.

Webinar: What’s New in TCPS 2? (November 3, 2011)

TCPS 2 (2010) Companion Documents

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

Highlights of TCPS 2 (PDF 56KB)

Table of Concordance 1st Ed. 1998 to 2nd Ed. 2010 (PDF 71KB)

Table of Concordance 2nd Ed. 2010 to 1st Ed. 1998 (PDF 75KB)

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TCPS 2 (2010) - Table of Contents

• Acknowledgements
• 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
    • Introduction
    • A. Scope of Research Ethics Review
    • B. Approach to Research Ethics Board Review
• Chapter 3
  • THE CONSENT PROCESS
    • Introduction
    • 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
    • Introduction
    • A. Appropriate Inclusion
    • B. Inappropriate Exclusion
• Chapter 5
  • PRIVACY AND CONFIDENTIALITY
    • Introduction
    • A. Key Concepts
    • 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
    • Introduction
    • A. Establishment of Research Ethics Boards
    • B. Procedures for Research Ethics Board Review
    • C. Reconsideration and Appeals
    • D. Research Ethics Review during Publicly Declared Emergencies
• Chapter 7
  • CONFLICTS OF INTEREST
    • Introduction
    • A. Key Concepts
    • B. Institutions and Conflicts of Interest
    • C. Research Ethics Board Members and Conflicts of Interest
    • D. Researchers and Conflicts of Interest
• Chapter 8
  • MULTI-JURISDICTIONAL RESEARCH
    • Introduction
    • A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple Research Ethics Boards
    • B. Review of Research Conducted Outside the Institution
• Chapter 9
  • RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND MÉTIS PEOPLES OF 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
    • Introduction
    • A. Nature of Qualitative Research
    • B. Research Ethics Review of Qualitative Research
      
• Chapter 11
  • CLINICAL TRIALS
• Introduction
• A. Key Concepts
• B. Clinical Trial Design and Registration
• C. Assessing Safety and Minimizing Risk
• D. Financial Conflicts of Interest
• E. Analysis and Dissemination of Clinical Trial Outcomes
  
• Chapter 12
  • HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS RELATED TO HUMAN REPRODUCTION
    • Introduction
    • 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
    • F. Research Involving Pluripotent Stem Cells
      
• Chapter 13
  • HUMAN GENETIC RESEARCH
    • Introduction
    • A. Application of Core Principles to Genetic Research
    • B. Plans for Managing Information Revealed through Genetic Research
    • C. Genetic Counselling
    • D. Genetic Research Involving Families
    • E. Genetic Research Involving Communities and Groups
    • F. Genetic Material Banks
    • G. Gene Transfer

Glossary

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