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Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
Tri-Council
Policy Statement: Ethical Conduct for Research Involving Humans
(PDF, 419 KB)
|
Notice: Effective 2003, the electronic version of the TCPS constitutes the official version of the policy document. The updates of May 2000, September 2002 and October 2005 have been 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.
- Subscribe to receive future updates
to the TCPS.
- 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
A. Mandate of the Agencies
B. Goals and Rationale of the Policy
Context
of an Ethics Framework
A. The Need for Research
B. A Moral Imperative: Respect
for Human Dignity
C. Guiding Ethical Principles
D. A Subject-Centred Perspective
E. Academic Freedoms and Responsibilities
F. Ethics and Law
G. Putting Principles into Practice
Section
1 - Ethics Review
A. Research Requiring Ethics
Review
B. Research Ethics Boards (REBs)
B1.
Authority of the REB
B2.
Membership of the REB
B3.
Number of REBs Within an Institution and Relationships Among REBs
C. Analysis, Balance and Distribution
of Harms and Benefits
C1.
Minimal Risk
C2.
Scholarly Review as Part of Ethics Review
D. Review Procedures
D1.
A Proportionate Approach to Ethics Assessment
D2.
Meetings and Attendance
D3.
Record Keeping
D4.
Decision Making
D5.
Reconsideration
D6.
Appeals
E. Conflicts of Interest
F. Review Procedures for Ongoing
Research
G. Review of Multicentred Research
H. Review of Research in Other
Jurisdictions or Countries
Section
2 - Free and Informed Consent
A. Requirement for Free and Informed Consent
B. Voluntariness
C. Naturalistic Observation
D. Informing Potential Subjects
D1.
General Conditions
E. Competence
F. Research in Emergency Health
Situations
Section 3 - Privacy and Confidentiality
A. Accessing Private Information: Personal Interviews
B. Accessing Private Information:
Surveys, Questionnaires and the Collection of Data
C. Secondary Use of Data
D. Data Linkage
Section
4 - Conflict of Interest
A. Conflicts of Interest Involving
Researchers
B. Conflicts of Interest by REB
Members
C. Institutional Conflicts of
Interest
Section
5 - Inclusion in Research
A. Introduction
B. Research Involving Women
C. Research Involving Those Who
Are Incompetent to Consent for Themselves
Section
6 - Research Involving Aboriginal Peoples
A. Introduction
B. Good Practices
Section
7 - Clinical Trials
A. Clinical Equipoise
B. Phases of Pharmaceutical Research
C. Multicentre Clinical Trials
D. Placebo-Controlled Studies
E. Analysis and Dissemination
of the Results of Clinical Trials
Section
8 - Human Genetic Research
A. The Individual, Families and
Biological Relatives
B. Privacy, Confidentiality,
Loss of Benefits and Other Harms
C. Genetic Counselling
D. Gene Alteration
E. Eugenic Concerns
F. Banking of Genetic Material
G. Commercial Use of Genetic
Data
Section
9 - Research Involving Human Gametes, Embryos or Foetuses
A. Research Involving Human Gametes
B. Research Involving Human Embryos
C. Research Involving Foetuses
D. Research Involving Foetal
Tissue
Section
10 - Human Tissue
A. Privacy and Confidentiality
B. Free and Informed Consent
C. Previously Collected Tissue
Appendices
Appendix 1: Scope of Research
Requiring Ethics Review
Appendix 2: Articles Included
in Tri-Council Policy Statement: Ethical Conduct for Research Involving
Humans
A. Chronological Listing
B. Numerical Listing
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| Last Modified: 2005-10-18 | 
|
Important Notices |
