Revisioning the Oversight of Research Involving Humans in Canada

When individuals are asked to participate in research they should be able to assume that the research is well designed and well executed, that the investigator is competent to undertake the study, that the study will be run efficiently, safely, and ethically and that the deviations from good practice will be identified and corrected. The central question that we focus on in this paper is whether the governance mechanisms that are currently in place to regulate the conduct of research involving humans are adequate to enable those who are approached to participate in research to make these assumptions. This review of the governance mechanisms in this area will be conducted through the lens of genetics and mental health research. This lens was selected because it provides vivid (and often under-appreciated) illustrations of the points which we wish to make about the governance of research. Additionally, genetics is one of the most focused upon area in research ethics and mental health is one of the least. We thought it useful to use examples from two ends of the spectrum