| 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 |
