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

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Table of Contents

Introduction
Goals of the Policy
A.Mandate of the Councils
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 & Attendance

D3.Record Keeping

D4.Decision-making

D5.Reconsideration

D6.Appeals

E.Conflicts of Interest
F.Review Procedures for Ongoing Research
G.Review of Multi-Centred 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 People
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 inTri-Council Policy Statement:
Ethical Conduct for Research Involving Humans

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