Regulating the uncertainty and risk of technique-centred innovations in healthcare
Sociology King's College London London, United Kingdom
The advancement of medical care is, in large part, driven by clinicians and patients who, respectively, develop and submit to experimental technologies. However, as such technologies develop and are translated into mainstream clinical care they carry risks and uncertainties for patients, practitioners and healthcare systems. This paper explores the oversight processes, practices and rationales used within a U.K. NHS Trust to attempt to address these uncertainties and risks within their hospital.
History has taught us of the risks associated with experimental/innovative treatments which are not rigorously tested prior to their diffusion into standard practice. However, while the likes of thalidomide sparked an international overhaul of the development and regulation of pharmaceutical drugs, more "craft-basedW developments, such as innovative surgical and clinical procedures, have remained largely under-regulated.
Hopkins (2006) contends that the embedded and autonomous nature of "technique-centred" innovation allows clinicians to change their practice while remaining hidden from external regulatory view. This hidden nature also contributes to the difficulties clinicians have in determining what counts as "innovative" and when external assessment is necessary. Various clinicians, ethicists and social scientists have identified this lack of regulation and the resultant risks presented, however few have explored attempts of tackling these concerns. One proposed solution is an internal, collegial Innovation Review Committee (IRC) charged with the task of assessing the acceptability of technique-centred innovations and the risks they pose "Morreim 2006". Nevertheless no empirical research on the practice, processes or feasibility of this model of regulation has been published.
This paper presents the findings of an ethnographic study exploring the workings of an IRC-like committee within an NHS Trust. Drawing on participant observation and semi-structured interviews this paper explores the issues of risk and uncertainty associated with technique-centred innovations and the difficulties this committee faced in attempting to judge safety in the unknown and unknowable territory of innovation.