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"Conceptual framework--setting the scene for 'protection' and 'promotion'" [2020] ELECD 279; in Dove, S. Edward (ed), "Regulatory Stewardship of Health Research" (Edward Elgar Publishing, 2020) 7

Book Title: Regulatory Stewardship of Health Research

Editor(s): Dove, S. Edward

Publisher: Edward Elgar Publishing

Section: Chapter 2

Section Title: Conceptual framework—setting the scene for ‘protection’ and ‘promotion’

Number of pages: 20

Abstract/Description:

This chapter queries whether the practices of RECs, specifically RECs within the National Health Services of the UK, align with their recently established regulatory mandate. In particular, it explores a shift from a protectionist model that has been seen by some as paternalistic, with regulators disproportionately focusing on research risks in comparison to research benefits, to a more broadly facilitative model, undergirded by law, that could be called ‘next-generation’ in that it seeks to foster an environment that both protects research participants and also facilitates responsible health research through proportionate, risk-based regulation and coordinated alignment of ethics review and other regulatory processes. This chapter raises the (empirically orientated) question of whether the roles and practices of RECs are shifting in compliance with this next-generation regulation.