The long arm of administrative law: applying administrative law principles to research ethics boards.

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.” 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. While this may accurately describe the system’s evolution, it no longer represents the reality.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.