A comparison of the new Federal Guidelines regulating supervised injection site research in Canada and the Tri-Council Policy Statement on Ethical Conduct for Research Involving Human Subjects

The Federal Government of Canada has recently published guidelines for researchers interested in studying supervised injection sites (SIS) in Canada. These guidelines articulate the criteria that must be satisfied before the Minister of Health will authorise any such research. The purpose of this paper is to provide a critical analysis of the new Federal Guidelines and compare them to the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS). The application of the TCPS ethical principles underscores the ethical probity of SIS research and demonstrates that SIS research qualifies as “minimal risk.” The new Federal Guidelines do not fully appreciate the innocuous nature of SIS research. The level of scrutiny associated with the new guidelines is disproportionate to the level of risk involved in SIS research and these expectations run the risk of limiting the amount of research that can occur. The uncritical acceptance of these guidelines could have the consequence of continuing to deny injection drug users (IDU) the benefits of this promising research on the grounds that there is an inadequate evidence base to establish SIS as the “standard of care.”