Tri­Council Policy Statement

Ethical Conduct
for Research
Involving Humans

TCPS2 2022
Canadian Institutes of Health Research
Natural Sciences and Engineering Research Council of Canada
Social Sciences and Humanities Research Council of Canada
Secretariat on Responsible Conduct of Research
secretariat@srcr-scrr.gc.ca
www.pre.ethics.gc.ca

On behalf of the:

Canadian Institutes of Health Research: www.cihr-irsc.gc.ca

Natural Sciences and Engineering Research Council of Canada: www.nserc-crsng.gc.ca

Social Sciences and Humanities Research Council of Canada: www.sshrc-crsh.gc.ca

Also available online in PDF and HTML formats

© His Majesty the King in Right of Canada, as represented by the Minister of Health and the Minister of
Innovation, Science and Industry, 2022
Catalogue No: RR4-2/2023E-PDF
ISBN: 978-0-660-45549-5
Tri-Council Policy Statement

Ethical Conduct for

Research Involving
Humans

TCPS2 2022
Canadian Institutes of Health Research
Natural Sciences and Engineering Research Council of Canada
Social Sciences and Humanities Research Council of Canada

Please cite this document as follows:

Canadian Institutes of Health Research, Natural Sciences and Engineering Research

Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-
Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2022.

Note: For the most recent information on amendments, please consult the official online
version of the TCPS at www.pre.ethics.gc.ca.
 TABLE OF CONTENTS
ACKNOWLEDGEMENTS .......................................................................................................................... 1

INTRODUCTION....................................................................................................................................... 2

CHAPTER 1 .............................................................................................................................................. 4
ETHICS FRAMEWORK ........................................................................................................................... 4
A. Importance of Research and Research Ethics .................................................................... 4
B. Core Principles ......................................................................................................................... 5
C. How to Apply This Policy ...................................................................................................... 10

CHAPTER 2 ............................................................................................................................................ 13
SCOPE AND APPROACH .................................................................................................................. 13
Introduction .................................................................................................................................. 13
A. Scope of Research Ethics Review ....................................................................................... 13
B. Approach to Research Ethics Board Review ..................................................................... 23

CHAPTER 3 ............................................................................................................................................ 31
THE CONSENT PROCESS .................................................................................................................... 31
Introduction .................................................................................................................................. 31
A. General Principles ................................................................................................................. 32
B. Departures from General Principles of Consent ............................................................... 45
C. Decision-Making Capacity .................................................................................................. 55
D. Consent Shall Be Documented ........................................................................................... 60
E. Broad Consent for the Storage of Data and Human Biological Materials for Future
Unspecified Research ........................................................................................................... 61

CHAPTER 4 ............................................................................................................................................ 66
FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION ..................................................................... 66
Introduction .................................................................................................................................. 66
A. Appropriate Inclusion ........................................................................................................... 67
B. Inappropriate Exclusion ........................................................................................................ 68

CHAPTER 5 ............................................................................................................................................ 77
PRIVACY AND CONFIDENTIALITY ..................................................................................................... 77
Introduction .................................................................................................................................. 77
A. Key Concepts ........................................................................................................................ 78
B. Ethical Duty of Confidentiality ............................................................................................. 81
C. Safeguarding Information .................................................................................................... 85
D. Consent and Secondary Use of Information for Research Purposes .............................. 87
E. Data Linkage ......................................................................................................................... 91

TCPS 2 (2022) i
CHAPTER 6 ............................................................................................................................................ 93
GOVERNANCE OF RESEARCH ETHICS REVIEW ................................................................................ 93
Introduction .................................................................................................................................. 93
A. Establishment of Research Ethics Boards ............................................................................ 93
B. Procedures for Research Ethics Board Review ................................................................ 105
C. Reconsideration and Appeals .......................................................................................... 115
D. Research Ethics Review during Publicly Declared Emergencies .................................... 117
E. Review of Sponsor-Researcher Contracts ........................................................................ 121

CHAPTER 7 .......................................................................................................................................... 124

CONFLICTS OF INTEREST .................................................................................................................. 124
Introduction ................................................................................................................................ 124
A. Key Concepts ...................................................................................................................... 125
B. Institutions and Conflicts of Interest ................................................................................... 127
C. Research Ethics Board Members and Conflicts of Interest ............................................. 129
D. Researchers and Conflicts of Interest ............................................................................... 130

CHAPTER 8 .......................................................................................................................................... 134

MULTI-JURISDICTIONAL RESEARCH ................................................................................................. 134
Introduction ................................................................................................................................ 134
A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple
Research Ethics Boards ...................................................................................................... 134
B. Ethics Review of Research Conducted Outside the Institution...................................... 141

CHAPTER 9 .......................................................................................................................................... 146

RESEARCH INVOLVING THE FIRST NATIONS, INUIT, AND MÉTIS PEOPLES OF CANADA................ 146
Introduction ................................................................................................................................ 146
A. Key Concepts and Definitions ........................................................................................... 149
B. Interpreting the Ethics Framework in Indigenous Contexts ............................................ 151
C. Applying Provisions of This Policy in Indigenous Contexts ............................................. 153

CHAPTER 10 ........................................................................................................................................ 183

QUALITATIVE RESEARCH ................................................................................................................. 183
Introduction ................................................................................................................................ 183
A. Nature of Qualitative Research ......................................................................................... 184
B. Research Ethics Review of Qualitative Research ............................................................. 188

CHAPTER 11 ........................................................................................................................................ 197

CLINICAL TRIALS .............................................................................................................................. 197
Introduction ................................................................................................................................ 197
A. Key Concepts ...................................................................................................................... 198
B. Ethical Issues for Clinical Trial Design and Review............................................................. 203

ii TCPS 2 (2022)
 C. Safety Monitoring and Reporting New Information........................................................ 216
D. Registration of Clinical Trials............................................................................................... 224

CHAPTER 12 ........................................................................................................................................ 227

HUMAN BIOLOGICAL MATERIALS INCLUDING
MATERIALS RELATED TO HUMAN REPRODUCTION ....................................................................... 227
Introduction ................................................................................................................................ 227
A. Key Concepts ...................................................................................................................... 228
B. Collection of Human Biological Materials ....................................................................... 229
C. Consent and Secondary Use of Human Biological Materials
for Research Purposes ....................................................................................................... 232
D. Storage and Banking of Human Biological Materials ..................................................... 236
E. Research Involving Materials Related to Human Reproduction ................................... 237
F. Research Involving Human Pluripotent Stem Cells ......................................................... 241
G. Cell Line Exemptions............................................................................................................ 248

CHAPTER 13 ........................................................................................................................................ 254

HUMAN GENETIC RESEARCH .......................................................................................................... 254
Introduction ................................................................................................................................ 254
A. Application of Core Principles to Genetic Research ....................................................... 254
B. Plans for Managing Information Revealed through Genetic Research ........................ 255
C. Genetic Counselling ........................................................................................................... 258
D. Genetic Research Involving Families ................................................................................ 258
E. Genetic Research Involving Communities and Groups ................................................. 259
F. Genetic Material Banks ..................................................................................................... 260
G. Gene Transfer....................................................................................................................... 261

GLOSSARY .......................................................................................................................................... 263

TCPS 2 (2022) iii

 ACKNOWLEDGEMENTS

This revised version of the Tri-Council Policy Statement: Ethical Conduct for Research
Involving Humans – TCPS 2 (2022) is the fruit of many contributions and invaluable
collaborative efforts by members of the Canadian research community. We are thrilled
to present this new version of the TCPS 2, which includes significant changes that we
believe will make it easier for REBs to review research projects and help meet the
evolving needs of the research community.

The research ethics themes that were part of the public consultation, and the final
revisions, represent the culmination of several years of deliberations and consultation by
the Panel on Research Ethics (PRE) and ad hoc subcommittees, with input from Agency
staff as appropriate. We want to thank our colleagues on PRE who contributed their
time and expertise to bring you this new and improved version of TCPS 2. We are also
grateful to the members of the public who provided feedback and shared their
experiences and knowledge.

This endeavour would not have been possible without input from the Secretariat on
Responsible Conduct of Research (Secretariat). The Secretariat’s invaluable support
throughout the process helped PRE contextualize concerns articulated by the research
community—both in terms of the Canadian research environment and the bioethics
literature at large—and ensure that they were addressed by the revisions to the TCPS 2.
We wish to acknowledge that significant time and thought has gone into efforts
beyond these updates to the TCPS 2. Past and present members of PRE and the
Secretariat also carried out public consultations, provided interpretations of the
guidance—including regarding the pandemic (COVID-19)—revamped the Course on
Research Ethics (CORE-2022), presented at national meetings and conferences, and
spent countless hours in fulfilling their responsibilities. All of these efforts serve to inform
and strengthen the revisions and the responsible conduct of human research in
Canada. For all of these contributions, we are extremely grateful.

Sincerely,

Conrad Fernandez Carolyn Ells

Chair, Panel on Research Ethics Chair, Panel on Research Ethics
(2022 to present) (2015 to 2021)

TCPS 2 (2022) 1
 INTRODUCTION

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
(TCPS or the Policy) is a joint policy of Canada’s three federal research agencies
– the Canadian Institutes of Health Research (CIHR), the Natural Sciences and
Engineering Research Council of Canada (NSERC), and the Social Sciences and
Humanities Research Council of Canada (SSHRC), or “the Agencies.”

This Policy expresses the Agencies’ continuing commitment to the people of

Canada to promote the ethical conduct of research involving humans. It has
been informed, in part, by leading international ethics norms, all of which may
help, in some measure, to guide Canadian researchers, in Canada and abroad,
in the conduct of research involving humans.

This edition introduces the second set of substantive changes to the Policy since
the second edition of the TCPS was launched in 2010. It reflects the commitment
of the Agencies to keep the TCPS current and responsive to the ethical issues
that arise in the course of research involving humans. Most importantly, it reflects
the feedback, questions and requests for guidance expressed by the research
community, and the responses generated by the Panel on Research Ethics and
the Secretariat on Responsible Conduct of Research. With these revisions to the
Policy, as well their interpretation service and outreach functions, the Panel and
Secretariat seek to facilitate the integration of ethics into the design and
conduct of research involving humans.

Mandate of the Agencies

The people of Canada, through Acts of Parliament,1 have created and funded
the Agencies to promote and assist research within their respective legislative
mandates. In discharging their mandates, the Agencies wish to promote
research that is conducted according to the highest ethical standards. The
Agencies have therefore adopted this Policy as a benchmark for the ethical
conduct of research involving humans.

Compliance with the Policy

As a condition of funding, the Agencies require that researchers and their

institutions apply the ethical principles and the articles of this Policy and be
guided by the Application sections of the articles. Institutions must therefore
ensure that research conducted under their auspices complies with this Policy.

2 TCPS 2 (2022)