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TCPS2
TRI - COUNCIL POLICY STATEMENT
Ethical Conduct for Research Involving Humans
2010
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 2010.
Note: For the most recent information on amendments, please consult the official online version of the TCPS at www.pre.ethics.gc.ca.
Permission is granted to photocopy this material.
Interagency Secretariat on Research Ethics 350 Albert Street
Ottawa, ON Canada K1A 1H5
613-996-0072 secretariat@pre.ethics.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 on the Web in PDF and HTML formats
© Her Majesty the Queen in Right of Canada (2010)
Catalogue No: MR21-18/2010E-PDF
ISBN 978-1-100-17237-81
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Table of Contents |
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Acknowledgements............................................................................................ |
1 |
|
INTRODUCTION .................................................................................................. |
5 |
|
Mandate of the Agencies .............................................................................. |
5 |
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Compliance with the Policy ........................................................................... |
5 |
|
Chapter 1 ......................................................................................................... |
7 |
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ETHICS FRAMEWORK ....................................................................................... |
7 |
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A. Importance of Research and Research Ethics............................................... |
7 |
|
B. |
Core Principles....................................................................................... |
8 |
C. |
How to Apply This Policy ....................................................................... |
11 |
Chapter 2........................................................................................................ |
15 |
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SCOPE AND APPROACH .................................................................................. |
15 |
|
Introduction ............................................................................................. |
15 |
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A. Scope of Research Ethics Review ............................................................. |
15 |
|
B. |
Approach to Research Ethics Board Review ............................................... |
22 |
Chapter 3........................................................................................................ |
27 |
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THE CONSENT PROCESS.................................................................................. |
27 |
|
Introduction ............................................................................................. |
27 |
|
A. |
General Principles................................................................................. |
28 |
B. |
Departures from General Principles of Consent........................................... |
37 |
C. |
Capacity.............................................................................................. |
40 |
D. Consent Shall Be Documented................................................................. |
44 |
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Chapter 4........................................................................................................ |
47 |
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FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION........................................ |
47 |
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Introduction ............................................................................................. |
47 |
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A. Appropriate Inclusion............................................................................ |
48 |
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B. |
Inappropriate Exclusion ......................................................................... |
48 |
Chapter 5........................................................................................................ |
55 |
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PRIVACY AND CONFIDENTIALITY..................................................................... |
55 |
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Introduction ............................................................................................. |
55 |
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A. Key Concepts ....................................................................................... |
55 |
|
B. |
Ethical Duty of Confidentiality ................................................................ |
58 |
C. |
Safeguarding Information ...................................................................... |
60 |
D. Consent and Secondary Use of Identifiable Information for |
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Research Purposes ................................................................................ |
62 |
E. |
Data Linkage........................................................................................ |
64 |
TCPS 2 |
i |
Chapter 6........................................................................................................ |
67 |
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GOVERNANCE OF RESEARCH ETHICS REVIEW .................................................... |
67 |
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Introduction ............................................................................................. |
67 |
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A. Establishment of Research Ethics Boards .................................................. |
67 |
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B. |
Procedures for Research Ethics Board Review ............................................ |
76 |
C. |
Reconsideration and Appeals .................................................................. |
83 |
D. Research Ethics Review during Publicly Declared Emergencies ...................... |
85 |
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Chapter 7........................................................................................................ |
89 |
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CONFLICTS OF INTEREST ................................................................................ |
89 |
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Introduction ............................................................................................. |
89 |
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A. Key Concepts ....................................................................................... |
89 |
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B. Institutions and Conflicts of Interest ....................................................... |
91 |
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C. Research Ethics Board Members and Conflicts of Interest ............................ |
93 |
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D. Researchers and Conflicts of Interest ....................................................... |
94 |
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Chapter 8........................................................................................................ |
97 |
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MULTI-JURISDICTIONAL RESEARCH................................................................. |
97 |
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Introduction ............................................................................................. |
97 |
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A. Review Mechanisms for Research Involving Multiple Institutions and/or |
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Multiple Research Ethics Boards .............................................................. |
97 |
B. Review of Research Conducted outside the Institution .............................. |
101 |
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Chapter 9 ...................................................................................................... |
105 |
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RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND |
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MÉTIS PEOPLES OF CANADA ......................................................................... |
105 |
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Introduction ........................................................................................... |
105 |
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A. Key Concepts and Definitions................................................................ |
107 |
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B. Interpreting the Ethics Framework in Aboriginal Contexts.......................... |
109 |
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C. Applying Provisions of This Policy in Aboriginal Contexts .......................... |
110 |
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Chapter 10 .................................................................................................... |
135 |
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QUALITATIVE RESEARCH .............................................................................. |
135 |
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Introduction ........................................................................................... |
135 |
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A. Nature of Qualitative Research .............................................................. |
135 |
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B. Research Ethics Review of Qualitative Research........................................ |
138 |
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Chapter 11 .................................................................................................... |
147 |
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CLINICAL TRIALS........................................................................................ |
147 |
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Introduction ........................................................................................... |
147 |
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A. Key Concepts ..................................................................................... |
148 |
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B. |
Clinical Trial Design and Registration ..................................................... |
149 |
ii |
TCPS 2 |
C. |
Assessing Safety and Minimizing Risk ..................................................... |
157 |
D. |
Financial Conflicts of Interest ............................................................... |
163 |
E. Analysis and Dissemination of Clinical Trial Outcomes............................... |
164 |
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Chapter 12 .................................................................................................... |
169 |
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HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS |
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RELATED TO HUMAN REPRODUCTION ............................................................. |
169 |
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Introduction ........................................................................................... |
169 |
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A. Types of Human Biological Materials ...................................................... |
169 |
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B. |
Collection of Human Biological Materials ................................................ |
170 |
C. |
Consent and Secondary Use of Identifiable Human Biological |
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Materials for Research Purposes ............................................................ |
172 |
D. Storage and Banking of Human Biological Materials ................................. |
175 |
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E. |
Research Involving Materials Related to Human Reproduction .................... |
176 |
F. Research Involving Pluripotent Stem Cells .............................................. |
179 |
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Chapter 13 .................................................................................................... |
181 |
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HUMAN GENETIC RESEARCH ......................................................................... |
181 |
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Introduction ........................................................................................... |
181 |
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A. |
Application of Core Principles to Genetic Research ................................... |
181 |
B. |
Plans for Managing Information Revealed through Genetic Research ........... |
182 |
C. |
Genetic Counselling ............................................................................. |
184 |
D. |
Genetic Research Involving Families ...................................................... |
184 |
E. |
Genetic Research Involving Communities and Groups ................................ |
185 |
F. |
Genetic Material Banks ........................................................................ |
186 |
G. Gene Transfer ..................................................................................... |
186 |
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Glossary |
........................................................................................................ |
189 |
Index ............................................................................................................ |
|
199 |
TCPS 2 |
iii |
Acknowledgements
In August 2010, in accordance with its mandate, the Interagency Advisory Panel on Research Ethics (the Panel) submitted its final version of the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) to 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,” and recommended the Policy’s adoption. The Agencies approved this 2nd edition of the TCPS, which incorporates the changes they deemed appropriate.
The Panel’s final version is a collaborative work. Over a period of almost three years, the TCPS was drafted and refined by the Panel and the Secretariat on Research Ethics (the Secretariat). The Policy has benefited from extensive public consultations with, and constructive criticism from, the research community of Canada. It would be impossible to individually thank the hundreds of people who have contributed to the revision process that has produced this Policy. But we would be remiss not to give credit to those volunteers and staff who have devoted countless hours of their attention and concern to develop this document that enhances the ethical conduct of research in Canada – and perhaps beyond.
The conception and refinement of the TCPS was carried out by the current and recent members of the Panel and Secretariat, led by Susan Zimmerman, Executive Director of the Secretariat. The enormity of the task they faced was matched by their dedication and tireless commitment to the vigorous collegial process. They warrant special acknowledgement for their efforts.
The development of this document has been a long process. The groundwork was laid by the first generation of Panel and Secretariat members led by Derek Jones, former Executive Director of the Secretariat, and the numerous working committee members who began the debate and framing of the issues that are addressed in the new edition.
Thanks are also due to the members of the research community who took part in the consultations in 2009 and provided comments on the 2008 and 2009 drafts. This national outreach involved meetings with roughly 2,000 members of the research community and yielded 370 submissions. The Panel found this feedback to be thoughtful, clear and critical to the revision process. As might be expected from such a wide array of independent-minded academics, administrators, practitioners and members of the general public – their views were not always compatible. Nevertheless, they furnished the grist for what we believe to be substantial improvements to the sequential drafts. Their efforts are deeply appreciated.
No document designed to cover the ethical conduct of all types of research involving humans can hope to be definitive. As with the 1st edition of the TCPS, the 2nd is a work in progress and is designed to be a living document. It is our hope and belief that the process we have employed, and the efforts of all those involved, will facilitate the ethical conduct of research.
Respectfully submitted by:
Norman Frohlich
Chair, Panel on Research Ethics (2007–2010)
Samuel K. Ludwin
Chair, Panel on Research Ethics (2010– )
TCPS 2 |
1 |
Panel Members
Samuel K. Ludwin, Chair (2010– ); Norman Frohlich, Chair (2007–2010); Michel Bergeron; Marlene Brant Castellano; Timothy Caulfield; Laurie Chan; Anne Dooley; Pierrette Fortin; Jim Frideres; James Lavery; Patrick O’Neill
Secretariat
Susan Zimmerman, Executive Director; Hanan Abdel-Akher; Laura-Lee Balkwill; Wendy Burgess; Thérèse De Groote; Guylaine Ménard; Heather Dana Munroe
Former Panel Members
Howard Brunt, Chair (2002–2005); Bruce Clayman , Chair (2005–2007); Pierre Deschamps; Hubert Doucet; Paul Johnston; Ian Mitchell; Florence Piron; Carol Sawka; Janice Singer; Maureen Smith; Susan Sykes;
Will van den Hoonaard; Peter Venner
Former Secretariat Members
Natasha Bendin; Michele Bourgeois-Doyle; Lucie Essiembre; Mary Fraser Valiquette; Derek Jones; Jacqueline Jorge
Clinical Trials Information (CTI) Working Committee
Albert Clark; Pierre Deschamps; Anne Dooley; Margo Farren;
Barry Hoffmaster; Peter Venner
Conflict of Interest Working Group
Norman Frohlich; Florence Piron; Susan Sykes; Peter Venner
Good Clinical Practice (GCP) Harmonization Committee
Marie-Claude Gauthier; Susan Hoddinott; Christine Nestruck
Guiding Consortium for the Development of TCPS Guidelines for Research Involving Aboriginal Peoples
Billie Allan; Kristiann Allen; Leah Bartlett; Margaret Blakeney; Marlene Brant Castellano; Kim Bulger; John Cheechoo; Laura Commanda;
Barbara Conway; Doris Cook; Carole Crête-Robidoux;
Geneviève Dubois-Flynn; Martine Dupré; Christine Fitzgerald;
2 |
TCPS 2 |
Marc Fonda; Lorraine Foreman; Valerie Gideon; Jane Gray; Karen Green; Eric Guimond; Janet Halliwell; Bonnie Healey; Kathy Hodgson-Smith; Roger Hunka; Karla Jessen Williamson; Danny Jette; Richard Jock; Samir Khan; Jay Lambert; Tracy Lavallee; Audrey Lawrence; Bonnie Leah; Alastair MacPhee;
D’Arcy McGuire; Céleste McKay; Craig McNaughton; Peter Monette; Earl Nowgesic; Scot Nickels; Onalee Randell; Jeff Reading; Nicole St-Onge; Jolene Saulis; Brian Schnarch; Christine Trauttmansdorff; Andrea Williams; Saga Williams; Erin Wolski; Deborah Wright; Nancy Zukewitch
Interagency Advisory Panel on Research Ethics – Technical Advisory Committee on Aboriginal Research (PRE-TACAR)
Kelly Bannister; Marlene Brant Castellano; Caroline Desbiens;
Brenda Elias; Willie J. Ermine; Minnie Gray; Eduardo Jovel;
Carrielynn Lund; Roger Maaka; Ted Palys; Gail Valaskakis
Subgroup on Procedural Issues for the TCPS (ProGroup)
Judith Abbott; Chantal Beauvais; Michel Bergeron; Howard Brunt; Michael Enzle; Susan Hoddinott; Bernard Keating; Raymond Martineau; Patrick O’Neill; Heather Sampson; Janice Singer; Susan Sykes
Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC)
Mary Blackstone; Lisa Given; Glenn Griener; Bernard Keating; Joseph Josy Lévy; Michelle McGinn; Kathleen Oberle; Patrick O’Neill; Michael Owen; Ted Palys;
Deborah Poff; Keren Rice; Will van den Hoonaard
Stem Cell Working Group
Bernard Dickens; Paul Johnston; Samuel K. Ludwin; Ian Mitchell
Translation Committee
Michel Bergeron, Joseph Josy Lévy, Isabelle Mondou
TCPS 2 |
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