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Hybrid design, systemic rigidity: Institutional dynamics in human research oversight

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  • Sydney Halpern

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.

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  • Sydney Halpern, 2008. "Hybrid design, systemic rigidity: Institutional dynamics in human research oversight," Regulation & Governance, John Wiley & Sons, vol. 2(1), pages 85-102, March.
    • Handle: RePEc:wly:reggov:v:2:y:2008:i:1:p:85-102
    DOI: 10.1111/j.1748-5991.2007.00032.x
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    1. Ezekiel J Emanuel & Trudo Lemmens & Carl Elliot, 2006. "Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?," PLOS Medicine, Public Library of Science, vol. 3(7), pages 1-1, July.
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    Cited by:

    1. Carol A. Heimer & Elsinore Kuo, 2021. "Subterranean successes: Durable regulation and regulatory endowments," Regulation & Governance, John Wiley & Sons, vol. 15(S1), pages 63-82, November.

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