Tri-council policy statement
Subtitle: ethical conduct for research involving humans
By: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada
Contributors: Natural Sciences and Engineering Research Council Canada; Social Sciences and Humanities Research Council of Canada; Interagency Secretariat on Research Ethics (Canada)
Publisher: Interagency Secretariat on Research Ethics
Published: 2010
Place of publication: Ottawa
Language: eng
Number of pages: 209
ISBN-13: 9781100172361
Subjects: Human experimentation in medicine; Government policy; Informed consent (Medical law); Medical ethics; Medicine; Research; Moral and ethical aspects
Other titles: Ethical conduct for research involving humans
Notes: "TCPS2."

Includes bibliographical references and index.
Table of contents: title: Introduction: Mandate of the agencies ; Compliance with the policy; title: 1. Ethics Framework; title: A. Importance of research and research ethics; title: B. Core principles; title: C. How to apply this policy; title: 2. Scope and approach; title: A. Scope of research ethics review; title: B. Approach to research ethics board review; title: 3. The consent process; title: A. General Principles; title: B. Departures from general principles of consent; title: C. Capacity; title: D. Consent shall be documented; title: 4. Fairness and equity in research participation; title: A. Appropriate inclusion; title: B. Inappropriate exclusion; title: 5. Privacy and confidentiality; title: A. Key concepts; title: B. Ethical duty of confidentiality; title: C. Safeguarding information; title: D. Consent and secondary use of identifiable information for research purposes; title: E. Data linkage.; title: 6. Governance of research ethics review; title: A. Establishment of research ethics boards; title: B. Procedures for REB review; title: C. Reconsideration and appeals; title: D. Research ethics review during publicly declared emergencies; title: 7. Conflicts of interest; title: A. Key concepts; title: B. Institutions and conflicts of interest; title: C. Research ethics board members and conflicts of interest; title: D. Researchers and conflicts of interest; title: 8. Multi-jurisdictional research; title: A. Review mechanisms for research involving multiple institutions and/or multiple research ethics boards; title: B. Review of research conducted outside the institution; title: 9. Research involving the First Nations, Inuit and Métis peoples of Canada; title: A. Key concepts and definitions; title: B. Interpreting the ethics framework in Aboriginal contexts; title: C. Applying provisions of this policy in Aboriginal contexts.; title: 10. Qualitative research; title: A. Nature of qualitative research; title: B. Research ethics review of qualitative research; title: 11. Clinical trials; title: A. Key concepts; title: B. Clinical trial design and registration; title: C. Assessing safety and minimizing risk; title: D. Financial conflicts of interest; title: E. Analysis and dissemination of the data and results of clinical trial outcomes; title: 12. Human biological materials including materials related to human reproduction; title: A. Types of human biological materials; title: B. Collection of human biological materials; title: C. Consent and secondary use of identifiable human biological materials for research purposes; title: D. Storage and banking of human biological materials; title: E. Research involving materials related to human reproduction; title: F. Research involving pluripotent stem cells.; title: 13. Human genetic research; title: A. Application of core principles to genetic research; title: B. Plans for managing information revealed through genetic research; title: C. Genetic counselling; title: D. Genetic research involving families; title: E. Genetic research involving communities and groups; title: F. Genetic material banks; title: G. Gene transfer.