Physicians gaming the system: modern-day Robin Hood?

I. Introduction Commentators have described the primary responsibility of research ethics boards (REBs) as that of ensuring that research projects involving human participants commence, or continue, only if the participants "are adequately informed, freely consent to participate, and . are not exposed to unreasonable risks of physical, social, psychological and economic harms that might occur as a result of participation. " (1) Whether REBs have the authority needed to perform this responsibility is a question that has animated much of the recent discussion over governance of the Canadian ethics review system. That discussion has been largely premised on a belief that the current system operates in an ad hoc fashion, without legislated mandates or enforcement mechanisms. (2) While this may accurately describe the system's evolution, it no longer represents the reality. REBs increasingly operate under mandates derived directly or indirectly from statute law. To the extent REBs derive their mandate from statute law, certain legal duties are likely owed to persons affected by their decision-making activities that deserve more attention than they have received to this point. These duties arise from administrative law, the domain of legal principle that governs the exercise of powers derived from delegated state authority. That administrative law should have an increasing influence on the development of research ethics review in Canada seems appropriate, given the important public interest role assigned to REBs, and the potential impact of their activities on members of the research community and participants in biomedical research alike. The paper is not an exhaustive treatment of the implications of administrative law for research ethics review in Canada. Rather, the goal is the more modest one of suggesting that this is an important area of legal concern that holds both promise and pitfalls, and should not continue to be neglected. The purpose of this overview, then, is two-fold: (1) to demonstrate the applicability of administrative law to much of what is currently occurring in research ethics review in Canada, particularly in university and hospital-based REBs; and (2) to show that administrative law can have a significant impact on the review of biomedical research and, consequently, on the interests of relevant stakeholders (researchers, research institutions, sponsors, research participants, the public, and REBs themselves). Biomedical research involving human subjects that takes place within Canada's public universities and hospitals is presently subject to two ethics regimes: the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (3) ("TCPS") and the Guideline for Good Clinical Practice E6 (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) ("GCP"). (4) While neither the TCPS nor the GCP have the status of self-applying legislation, there is considerable reason to believe courts would look to these instruments as establishing minimum standards for REB performance. (5) The key question is whether the REB in question is itself subject to administrative law obligations. University and hospital-based REBs operate in an area of some ambiguity in this regard. In our view, most would likely be subject to administrative law on one or more of the following bases: they derive their authority from parent statutes which permit university and hospital boards to create internal bodies with mandatory powers; they operate at least indirectly under government control, through research funding agreements; and they serve important public purposes within a statutory context. Part II of this paper explores these arguments. In addition to the TCPS and GCP (but often incorporating them), Canadian law-makers have enacted several statutory mandates regulating different facets of health research involving human subjects. …