Regulating for uncertainty: bridging blurred boundaries in medical innovation, research and treatment

This paper explores the blurred conceptual boundaries between ‘practice/treatment’, ‘research’ and ‘medical innovation’ in order to inform what these mean – and can mean – for regulation of these fields of enquiry. These terms are constantly employed within the sphere of health and human health research regulation, but there is a lack of clarity and consistency in the ways in which the activities are categorised. This gives rise to confusion and can negatively impact treatment/research and innovation. I argue that it is not only timely but also necessary to revisit our current conceptualisations of these key activities, with a particular emphasis on medical innovation. The proposal is to reimagine regulatory landscapes – including regulation – in more holistic terms that reflect the processes that transgress these categories and to understand better the blurred boundaries that exist between them. I suggest that the anthropological concept of liminality is particularly helpful in developing more holistic understandings of medical innovation that reflect the processes and relationships that exist. Importantly, it provides us with a new conceptualisation of medical innovation as a shared space where both practice/treatment and research can co-exist.