Through the Thicket and Across the Divide: Successfully Navigating the Regulatory Landscape in Life Sciences Research

Abstract

This chapter addresses the considerable problems that arise within and between regulatory regimes when there is a failure to implement intelligent design that is responsive to the realities of life sciences research. We argue that a root cause of these problems is the dichotomization of regulatory regimes as between tissue and data and the creation of a non-nexus between bodies of knowledge and legal responses to technological developments. The result is a regulatory thicket and a net failure to deliver effective, efficient and proportionate regimes. Taking the UK and European context as its example, this chapter argues for a collapse in the distinction between tissue and data and for more fluid and reflexive governance systems that not only embody interdisciplinary intelligent design but are also constructed around legal architectures that are responsive to changing scientific and social mores. This requires less, not more, proscription from law.

Keywords: Health-related research, regulation, data protection, tissue, reflexive governance