Draft 2^nd Edition of the TCPS (December 2008)

Notice: the TCPS 1^st edition (1998) will remain current until the 2^nd edition is published.

Draft 2^nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2008) (PDF, 843 KB)

Towards A Second Edition

When CIHR, NSERC and SSHRC adopted the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) in 1998, they committed to keeping it a living document. Doing so involves responding to new research developments, identifying gaps and proposing modifications of existing research ethics norms.

The Interagency Advisory Panel on Research Ethics (PRE) is thus mandated by the Agencies to advise on the evolution of the TCPS. PRE does so in a national and international context that recognizes diverse research ethics needs, activities and environments. To inform its deliberations and recommendations, PRE relies on transparent and inclusive processes of community and public engagement.

In December 2008, the Interagency Advisory Panel on Research Ethics released a substantial revision to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) for public consultation.  The consultation period closed on June 30, 2009.

The Panel released a revised version of the draft to the public for further comment in December 2009 followed by a 75-day written consultation period. The Panel is preparing a final draft based on those comments. In April 2010, the Panel expects to submit a final revision to the Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC) for their consideration.

Companion Documents

The following PDF documents highlight the proposed changes to the TCPS.

What's New in the TCPS

Table of Concordance - Old to New Version

Table of Concordance - New to Old Version

Table of Contents

• Chapter 1
  • ETHICS FRAMEWORK
    • A. The Importance of Research and Research Ethics
    • B. Core Principles
    • C. A Guide to this Policy
• Chapter 2
  • SCOPE AND APPROACH
    • A. Scope of Ethics Review
    • B. Approach to Research Ethics Board Review
  • Appendix
  • Examples of Research that Does Not Require Research Ethics Board Review
• Chapter 3
  • FREE AND INFORMED CONSENT
    • A. General Principles
    • B. Departures from General Principles of Consent
    • C. Capacity
• Chapter 4
  • INCLUSION IN RESEARCH
    • A. Introduction
    • B. General Inclusivity of Research
    • C. Research Involving Women
    • D. Research Involving Vulnerable Persons or Groups
    • E. Research Involving Those Who Lack Capacity to Consent for Themselves
• Chapter 5
  • PRIVACY AND CONFIDENTIALITY
    • A. Key Definitions and Principles
    • B. The Duty of Confidentiality
    • C. Safeguarding Information
    • D. Secondary Use of Personal Information for Research Purposes
    • E. Data Linkage
• Chapter 6
  • GOVERNANCE OF RESEARCH ETHICS REVIEW
    • A. Establishment of Research Ethics Boards
    • B. Procedures for REB Review
    • C. Reconsideration and Appeals
    • D. Research Ethics Review During Publicly Declared Emergencies
• Chapter 7
  • CONFLICT OF INTEREST
    • A. Institutions and Conflicts of Interest
    • B. REB Members and Conflicts of Interest
    • C. Researchers and Conflicts of Interest
• Chapter 8
  • MULTI-JURISDICTIONAL RESEARCH
    • A. Review Mechanisms for Research Involving Multiple Institutions and Research Ethics Boards
    • B. Review of Research Conducted Outside a REB’s Jurisdiction
    • C. Other Ethics Considerations When Reviewing Research Conducted Outside the Jurisdiction of the REB
• Chapter 9 (click here for November 2009 revision)
  • RESEARCH INVOLVING ABORIGINAL PEOPLES
    • A. Interpreting the Ethics Framework in Aboriginal Contexts
    • B. Ethical Concerns in Research Involving Aboriginal Peoples
    • C. Applying Provisions of this Policy in Aboriginal Contexts
    • D. Research Processes and Ethics Review
• Chapter 10
  • QUALITATIVE RESEARCH
    • A. The Nature of Qualitative Research
    • B. Research Ethics Review in the Context of Issues Distinctive to Qualitative Research
• Chapter 11
  • CLINICAL TRIALS
    • A. Overview
    • B. Phases of Clinical Trials
    • C. Assessing Safety and Minimizing Risk
    • D. Sharing New Information
    • E. Therapeutic Misconception
    • F. Financial Conflicts of Interest
    • G. Placebo-Controlled Studies
    • H. Analysis and Dissemination of the Data and Results of Clinical Trials
• Chapter 12
  • HUMAN TISSUE
    • A. Identifiability of Tissue
    • B. Tissue Collection
    • C. Tissue Storage and Banking
    • D. Secondary Use of Previously Collected Tissue
    • E. Human Reproductive Tissue
• 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