The governance of research involving human participants in Canada.

Research involving humans has a long history, marked by both success and failure. It has become a vast and complex activity due to the multiple actors involved, its growing international implications and evolving context, the sustained attention from standard setting authorities, and finally, but not the least, the many underlying interests that sometimes compete or conflict. This has resulted in increased public scrutiny over the past few decades in some countries like the United States and only more recently in others like Canada. In the midst of the repeated calls for increased public oversight of research activities, much attention has focussed on the development of social, ethical and legal norms. In addition, in many countries, ethics review committees (or research ethics boards (REBs) as they are called in Canada) were created to serve as the primary oversight mechanism of research involving humans primarily based in the institutional setting. These committees were created to review research protocols from a research ethics perspective that alms to promote ethical reflection and behaviour among those involved in research, with a particular focus on protecting and promoting the dignity and well-being of research participants. Ethics review committees have come under a lot of pressure and criticism in the past years and various national solutions proposed including, in some cases, in depth restructuring of the ethics review system that would include accreditation. (1) In Canada, ethics review committees have also come under review and many deficiencies, similar to those documented in other countries, identified. (2) Moreover, and as in other countries, the most recent reviews address research ethics issues from a broader governance approach in an attempt to tease out deficiencies in research participant protection that may be due to the environment within which ethics committees must operate as opposed to the committees themselves. Canadian reviews have primarily focussed on publicly funded research conducted in institutions and less attention has gone to the many other types of research involving humans: government research, charity or community based research, provincially-funded research and privately funded and conducted research. While there is agreement across the various reports that something has to be done to reinforce the ethics review function, relatively little ground has been covered towards reaching an agreement on the underlying issues and finding creative solutions and, eventually, implementing them. In fact, there appears to be a chronic inability to reach an agreement on what needs fixing and moving towards implementing possible solutions. This paper analyses issues raised by the governance of research involving humans from the participants' perspective postulating that similar protections ought to exist irrespective of the source of funding for, or the location of the research. Carefully considering the various reports published to date, it attempts to clarify the global Canadian context for research involving human participants in order to shed light on the current governance mechanisms and move towards a common understanding of the core issues. To achieve this, two key questions continue to be explored here: First, how is research involving human subjects currently governed? And, second, how effective are the current governance arrangements and what common issues emerge? (3) The aim of this paper is not so much to answer these questions, as it is first, to discuss the current governance context and, second, to identify eight significant or core issues that they raise, and provide guidance on developing a common understanding about them. To address research ethics issues from the perspective of public governance is to focus on dements of good governance. These include accountability, oversight and transparency, clear government roles and responsibilities, clear relationships, structures and standards, and public processes, mechanisms and participation. …