Reimagining Regulatory Approaches: on the Essential Role of Principles in Health Research Regulation
Authors
Nayha Sethi
Research Fellow and Doctoral Candidate, Deputy Director of the Mason Institute, School of Law.University of Edinburgh. I would like to thank Prof Graeme Laurie for his helpful comments. Iacknowledge the support from the Farr Institute @ Scotland. The Farr Institute of Scotland issupported by a 10-funder consortium: Arthritis Research UK, the British Heart Foundation, CancerResearch UK, the Economic and Social Research Council, the Engineering and Physical SciencesResearch Council, the Medical Research Council, the National Institute of Health Research, theNational Institute for Social Care and Health Research (Welsh Assembly Government), the ChiefScientist Office (Scottish Government Health Directorates), (MRC Grant No: MR/K007017/1)
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
