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

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (1998) (PDF, 419 KB)

Notice: TCPS 2 has replaced the 1st edition of the TCPS (1998) as the official human research ethics policy of the Agencies.

The following version of the 1st edition of the TCPS includes updates from May 2000, September 2002 and October 2005 that were integrated into both the text and appendices of the electronic versions (HTML and PDF).

Please cite this document as follows: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 1998 (with 2000, 2002 and 2005 amendments).

  • To view updates individually, go to the Updates page.
  • HTML Version:
    Catalogue Number: MR21-18/2005E
    ISBN: 0-662-40237-5

(For information regarding copyright and reproduction, please see Important Notices.)

Contents:

Introduction

Goals of the Policy

  1. Mandate of the Agencies
  2. Goals and Rationale of the Policy

Context of an Ethics Framework

  1. The Need for Research
  2. A Moral Imperative: Respect for Human Dignity
  3. Guiding Ethical Principles
  4. A Subject-Centred Perspective
  5. Academic Freedoms and Responsibilities
  6. Ethics and Law
  7. Putting Principles into Practice

Section 1 - Ethics Review

  1. Research Requiring Ethics Review
  2. Research Ethics Boards (REBs)
    1. Authority of the REB
    2. Membership of the REB
    3. Number of REBs Within an Institution and Relationships Among REBs
  3. Analysis, Balance and Distribution of Harms and Benefits
    1. Minimal Risk
    2. Scholarly Review as Part of Ethics Review
  4. Review Procedures
    1. A Proportionate Approach to Ethics Assessment
    2. Meetings and Attendance
    3. Record Keeping
    4. Decision Making
    5. Reconsideration
    6. Appeals
  5. Conflicts of Interest
  6. Review Procedures for Ongoing Research
  7. Review of Multicentred Research
  8. Review of Research in Other Jurisdictions or Countries

Section 2 - Free and Informed Consent

  1. Requirement for Free and Informed Consent
  2. Voluntariness
  3. Naturalistic Observation
  4. Informing Potential Subjects
    1. General Conditions
  5. Competence
  6. Research in Emergency Health Situations

Section 3 - Privacy and Confidentiality

  1. Accessing Private Information: Personal Interviews
  2. Accessing Private Information: Surveys, Questionnaires and the Collection of Data
  3. Secondary Use of Data
  4. Data Linkage

Section 4 - Conflict of Interest

  1. Conflicts of Interest Involving Researchers
  2. Conflicts of Interest by REB Members
  3. Institutional Conflicts of Interest

Section 5 - Inclusion in Research

  1. Introduction
  2. Research Involving Women
  3. Research Involving Those Who Are Incompetent to Consent for Themselves

Section 6 - Research Involving Aboriginal Peoples

  1. Introduction
  2. Good Practices

Section 7 - Clinical Trials

  1. Clinical Equipoise
  2. Phases of Pharmaceutical Research
  3. Multicentre Clinical Trials
  4. Placebo-Controlled Studies
  5. Analysis and Dissemination of the Results of Clinical Trials

Section 8 - Human Genetic Research

  1. The Individual, Families and Biological Relatives
  2. Privacy, Confidentiality, Loss of Benefits and Other Harms
  3. Genetic Counselling
  4. Gene Alteration
  5. Eugenic Concerns
  6. Banking of Genetic Material
  7. Commercial Use of Genetic Data

Section 9 - Research Involving Human Gametes, Embryos or Fetuses

  1. Research Involving Human Gametes
  2. Research Involving Human Embryos
  3. Research Involving Fetuses
  4. Research Involving Foetal Tissue

Section 10 - Human Tissue

  1. Privacy and Confidentiality
  2. Free and Informed Consent
  3. Previously Collected Tissue

Appendices

Summary of Amendments

  1. Chronological Listing
  2. Numerical Listing

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