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Book 29:  2020 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans

Book 29: 2020 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans

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This book contains the full 2018 revised contents of the Tri-Council Policy Statement for Research Involving Human Subjects.

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Table of Contents
Acknowledgements............................................................................................1
INTRODUCTION..................................................................................................3
Mandate of the Agencies ..............................................................................3
Compliance with the Policy ...........................................................................3
Chapter 1 .........................................................................................................5
ETHICS FRAMEWORK .......................................................................................5
A. Importance of Research and Research Ethics...............................................5
B. Core Principles.......................................................................................6
C. How to Apply This Policy .........................................................................9
Chapter 2........................................................................................................13
SCOPE AND APPROACH..................................................................................13
Introduction .............................................................................................13
A. Scope of Research Ethics Review.............................................................13
B. Approach to Research Ethics Board Review ...............................................20
Chapter 3........................................................................................................25
THE CONSENT PROCESS..................................................................................25
Introduction .............................................................................................25
A. General Principles.................................................................................26
B. Departures from General Principles of Consent...........................................35
C. Decision-Making Capacity ......................................................................42
D. Consent Shall Be Documented.................................................................46
Chapter 4........................................................................................................49
FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION........................................49
Introduction .............................................................................................49
A. Appropriate Inclusion............................................................................50
B. Inappropriate Exclusion.........................................................................50
Chapter 5........................................................................................................57
PRIVACY AND CONFIDENTIALITY.....................................................................57
Introduction .............................................................................................57
A. Key Concepts .......................................................................................57
B. Ethical Duty of Confidentiality ................................................................60
C. Safeguarding Information ......................................................................62
D. Consent and Secondary Use of Identifiable Information for
Research Purposes ................................................................................64
E. Data Linkage........................................................................................67
TCPS 2 (2014) i
Chapter 6........................................................................................................69
GOVERNANCE OF RESEARCH ETHICS REVIEW ....................................................69
Introduction .............................................................................................69
A. Establishment of Research Ethics Boards ..................................................69
B. Procedures for Research Ethics Board Review ............................................78
C. Reconsideration and Appeals ..................................................................86
D. Research Ethics Review during Publicly Declared Emergencies ......................87
Chapter 7........................................................................................................93
CONFLICTS OF INTEREST ................................................................................93
Introduction .............................................................................................93
A. Key Concepts .......................................................................................93
B. Institutions and Conflicts of Interest .......................................................95
C. Research Ethics Board Members and Conflicts of Interest ............................97
D. Researchers and Conflicts of Interest .......................................................98
Chapter 8 ......................................................................................................101
MULTI-JURISDICTIONAL RESEARCH...............................................................101
Introduction ...........................................................................................101
A. Review Mechanisms for Research Involving Multiple Institutions and/or
Multiple Research Ethics Boards ............................................................101
B. Ethics Review of Research Conducted outside the Institution .....................105
Chapter 9 ......................................................................................................109
RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND
MÉTIS PEOPLES OF CANADA .........................................................................109
Introduction ...........................................................................................109
A. Key Concepts and Definitions................................................................111
B. Interpreting the Ethics Framework in Aboriginal Contexts..........................113
C. Applying Provisions of This Policy in Aboriginal Contexts ..........................114
Chapter 10 ....................................................................................................139
QUALITATIVE RESEARCH ..............................................................................139
Introduction ...........................................................................................139
A. Nature of Qualitative Research ..............................................................139
B. Research Ethics Review of Qualitative Research........................................142
Chapter 11 ....................................................................................................151
CLINICAL TRIALS........................................................................................151
Introduction ...........................................................................................151
A. Key Concepts .....................................................................................152
B. Clinical Trial Design and Registration .....................................................154
ii TCPS 2 (2014)
C. Assessing Safety and Minimizing Risk.....................................................161
D. Financial Conflicts of Interest ...............................................................168
E. Analysis and Dissemination of Clinical Trial Outcomes...............................169
Chapter 12 ....................................................................................................175
HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS
RELATED TO HUMAN REPRODUCTION.............................................................175
Introduction ...........................................................................................175
A. Key Concepts .....................................................................................175
B. Collection of Human Biological Materials ................................................177
C. Consent and Secondary Use of Identifiable Human Biological
Materials for Research Purposes ............................................................178
D. Storage and Banking of Human Biological Materials .................................181
E. Research Involving Materials Related to Human Reproduction ....................183
F. Research Involving Human Pluripotent Stem Cells ....................................185
Chapter 13 ....................................................................................................193
HUMAN GENETIC RESEARCH .........................................................................193
Introduction ...........................................................................................193
A. Application of Core Principles to Genetic Research ...................................193
B. Plans for Managing Information Revealed through Genetic Research ...........194
C. Genetic Counselling.............................................................................196
D. Genetic Research Involving Families ......................................................196
E. Genetic Research Involving Communities and Groups ................................197
F. Genetic Material Banks ........................................................................198
G. Gene Transfer .....................................................................................198
Glossary ........................................................................................................201
 

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