Multiple institutional rationalities in the regulation of health technologies: An ethnographic examination

The regulation of risk associated with health technologies uses scientific evaluation to identify harms and protect citizens. However, in some cases scientific uncertainty has resulted in regulatory failures (e.g. Cox-2 inhibitors) and led regulators to explore new ways of working, such as bringing in the expertise of new actors (patient groups, community health workers, caregivers, etc.), to provide evidence and assessment in the regulation of risk. Implementing changes, however, can be an uncertain process in itself. Regulatory institutions are populated with actors representing a range of disciplinary perspectives, priorities, and values, which all influence their rationality towards accepting an introduced innovation. This paper provides an ethnographic exploration of disciplinary boundaries and multiple rationalities during a period of institutional transformation, within the Canadian Health Products and Food Branch. We interpret our findings through a multiple rationalities framework, illuminating the processes and practices of transformative risk regulation. Copyright , Beech Tree Publishing.