Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022)

Table of Contents

• Acknowledgements
• Introduction
  • Mandate of the Agencies
  • Compliance with the Policy
• Chapter 1 – Ethics Framework
  • A. 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. Decision-Making Capacity
  • D. Consent Shall Be Documented
  • E. Broad Consent for the Storage of Data and Human Biological Materials for Future Unspecified Research
• 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. 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
  • E. Review of Sponsor-Researcher Contracts
• 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. Ethics 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 Indigenous Contexts
  • C. Applying Provisions of This Policy in Indigenous 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. Ethical Issues for Clinical Trial Design and Review
  • C. Safety Monitoring and Reporting New Information
  • D. Registration of Clinical Trials
• Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
  • Introduction
  • A. Key Concepts
  • B. Collection of Human Biological Materials
  • C. Consent and Secondary Use of 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 Human Pluripotent Stem Cells
  • G. Cell Line Exemptions
• 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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Date modified:

2023-01-11