Reimagining Regulatory Approaches: on the Essential Role of Principles in Health Research Regulation

Abstract

This article calls for a reimagining of regulatory approaches to health research. It is argued that an essential first step of such a reimagining involves the development of a deeper understanding of the diverse and indispensable roles which principles can play as regulatory decision-making aids. This topic merits attention given the fact that we perpetually rely upon principles without really considering what it is we are asking principles to do within the regulatory environment. In particular, this paper considers how principles can assist in addressing key challenges which new technologies pose to regulation, as well as the relationships that might exist between principles and rules in such instances. The discussion here takes place against the backdrop of the complex and evolving landscape of the governance of the reuse of data for health research. At the same time, the contributions in this article can be of real value to contemporary challenges in a far wider array of governance contexts beyond the health setting