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Governance-by-standards in the field of stem cells: managing uncertainty in the world of 'basic innovation'

机译:干细胞领域的标准治理:管理“基础创新”领域的不确定性

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This paper explores the role of the International Stem Cell Initiative (ISCI) in its attempt to develop biological standards and experimental protocols for the embryonic field as a whole. Drawing on empirical research derived from UK and other labs and fieldwork within ISCI meetings, we describe the way standards have emerged and the difficulties in stabilizing them at the local level. The paper discusses the ways in which this form of governance-by-standards acts to manage uncertainty - to a degree - and suggests that this requirement to manage uncertainty is becoming a key characteristic of what we call "basic innovation". We conclude by drawing out the implications of this for the management of uncertainty and the increasingly diverse regulatory space that will be needed to oversee the eventual clinical application of hESC.
机译:本文探讨了国际干细胞倡议组织(ISCI)在为整个胚胎领域制定生物学标准和实验方案方面的作用。借鉴英国和ISCI会议中其他实验室和实地调查得出的实证研究结果,我们描述了标准出现的方式以及在地方一级稳定标准的困难。本文讨论了这种形式的标准治理在某种程度上用于管理不确定性的方式,并建议这种管理不确定性的要求已成为我们所谓的“基本创新”的关键特征。最后,我们总结了这一点对不确定性管理的意义,以及监督hESC最终临床应用所需的日益多样化的监管空间。

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