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  • 21 - Regulatory Authorities and Decision-Making in Health Research

  • from Section IB - Tools, Processes and Actors
  • Edited by Graeme Laurie, University of Edinburgh, Edward Dove, University of Edinburgh, Agomoni Ganguli-Mitra, University of Edinburgh, Catriona McMillan, University of Edinburgh, Emily Postan, University of Edinburgh, Nayha Sethi, University of Edinburgh, Annie Sorbie, University of Edinburgh
  • Book:
    The Cambridge Handbook of Health Research Regulation
    Published online:
    09 June 2021
    Print publication:
    24 June 2021, pp 205-214
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  • Summary

    Institutional theories examine the way in which policies and decisions are structurally determined by institutions. They broadly suggest that institutions – and specific institutional contexts within which decision-making actors operate – influence and at times constrain decision-making actors in their decisions. The discussion of the effects and influences of institutional contexts on downstream decision-making outcomes and actors is limited within mainstream legal literature. This chapter seeks to fill this gap. It argues that the effect of institutional frameworks is particularly acute where discretion on the application or scope of a legal provision, guidance or rule is left to the decision-maker. Accordingly, the chapter argues that institutional factors and contexts should be very carefully scrutinised when adopting policy/legal changes, and particularly when drafting new provisions or guidance to be applied in any legal/regulatory context, including in the health research regulation context.