Institutions / Organizations

• National Council on Ethics in Human Research (NCEHR)
• Interagency Panel on Research Ethics (PRE)
• Canadian Association of Research Ethics Boards (CAREB)
• Canadian Institutes of Health Research (CIHR) Ethics Office
• Canadian Bioethics Society

Key Documents

• Tri-Council Policy Statement (TCPS)
• Personal Information Protection and Electronic Documents Act (PIPEDA)
• Good Clinical Practice: Consolidated Guideline
• CIHR Guidelines for Health Research Involving Aboriginal People
• CIHR Best Practices for Protecting Privacy in Health Research
• Interim Tri-Agency Measures for Human Pluripotent Stem Cell Research

Articles

• “Bioethics for Clinicians 10: Research Ethics”(Weijer C, Dickens B, Meslin E.  Canadian Medical Association Journal 1997; 156: 1153-1157)
• “Bioethics for Clinicians 17: Conflict of interest in research, education and patient care” (Trudo Lemmens & Peter A. Singer, Canadian Medical Association Journal 1997; 156: 1153-1157)

Research Ethics in Canada: Brief Overview

Human subjects research in Canada is generally governed by a document known as the Tri-Council Policy Statement (TCPS). “Tri-Council” is a reference to Canada’s three federal granting agencies, namely the Canadian Institutes of Health Research (CIHR), the Social Sciences and Humanities Research Council (SSHRC), and the Natural Sciences and Engineering Research Council (NSERC). The TCPS was issued in 1998, with amendments made in 2000, 2002, and 2005. The TCPS guides the review of all research conducted at institutions funded by any of those 3 agencies (i.e., all Canadian universities and many hospitals) and is considered the minimal standard for the ethical review of research involving humans. The interpretation and enforcement of the principles found within the TCPS is left to universities and hospitals, most of which have “Research Ethics Boards” (REBs) whose job it is to review research proposals and monitor ongoing research to ensure compliance with the TCPS.

The TCPS has recently been revised and the newest edition will be available in early 2009. Some of the changes and updates reflect a need for the TCPS to better address issues in qualitative research and creative practices. Additional refinements to notions such as risk of harm, privacy and confidentiality, vulnerability, delegated review and continuing review of research have been proposed and significant public consultation has been carried out as part of the process of revision.

Some kinds of research (e.g., drug trials) must meet additional requirements (such as those set out in Health Canada’s Clinical Trials Regulations). Canadian REBs often seek guidance, in addition, from such influential international documents as the Declaration of Helsinki.

See also:

• The Research Ethics Blog