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Keywords:

  • human research;
  • human subjects protections;
  • hybrid regulation;
  • new governance;
  • regulatory flexibility;
  • regulatory responsiveness

Abstract

New governance scholars see hybrid regulation as a means for achieving regulatory flexibility and responsiveness. The US system for overseeing human subjects research embodies three dimensions of hybridity: it brings together governmental and non-governmental controls; it combines central and local authority; and it engages a multiplicity of policy actors. Yet this system became rigid 20 years into its development. Sources of rigidity included shifts in the regulatory environment, temporal constriction in the range policy participants, and risk aversion on the part of non-governmental institutions charged with implementing federally mandated controls. This article explores the implications of these institutional dynamics for the relationship between hybridity and regulatory responsiveness. It also examines possibilities for renewed flexibility generated by the recent advent of both accreditation and regulatory innovation by university research administrators.