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

• 成果类型: Article
• 署名作者: Halpern, Sydney
• 署名单位: University of Illinois System; University of Illinois Chicago; University of Illinois Chicago Hospital
• 刊物名称: REGULATION & GOVERNANCE
• ISSN/ISSBN: 1748-5983
• DOI: 10.1111/j.1748-5991.2007.00032.x
• 发表日期: 2008
• 页码: 85-102
• 关键词: RISE

摘要

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-govern mental 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.