Comparing national home-keeping and the regulation of translational stem cell applications: An international perspective
Comparing national home-keeping and the regulation of translational stem cell applications: An international perspective
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比较国家内政和转化干细胞应用的监管：国际视角
DOI：
10.1016/j.socscimed.2016.01.047
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Wakana Suzuki et al.
中科院分区：
文献类型：
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作者：
Sleeboom-Faulkner;Choon Key Chekar ;Wakana Suzuki et al.
转化干细胞研究和符合随机对照试验理想以及良好实验室和临床实践的应用之间存在很大的灰色地带，这就是通常所说的万金油贸易。我们发现国际研究和伦理监管以及干细胞领域监管工具在实践中开发的方式之间存在差异。我们使用“国家内政”的概念来研究这种差异，指的是政府阐明国际标准和监管与国内当地参与者相互冲突的要求的方式。确定了监管工具的特定维度——权力、许可、空间和加速——对于亚洲、欧洲和美国的国家内政至关重要，我们展示了地方监管如何发挥作用，以促进该领域的发展，尽管有国际（即主要是“西方”）监管。通过2012年至2015年的实证数据和档案研究对监管进行三角测量，帮助我们揭示了国家和组织如何通过操纵监管工具（取决于国家规模、国家积累资源的能力、医疗保健需求、既定的科学治理传统以及经济和科学野心）来适应和抵制国际主导监管。
A very large grey area exists between translational stem cell research and applications that comply with the ideals of randomised control trials and good laboratory and clinical practice and what is often referred to as snake-oil trade. We identify a discrepancy between international research and ethics regulation and the ways in which regulatory instruments in the stem cell field are developed in practice. We examine this discrepancy using the notion of ‘national home-keeping’, referring to the way governments articulate international standards and regulation with conflicting demands on local players at home.Identifying particular dimensions of regulatory tools – authority, permissions, space and acceleration – as crucial to national home-keeping in Asia, Europe and the USA, we show how local regulation works to enable development of the field, notwithstanding international (i.e. principally ‘western’) regulation. Triangulating regulation with empirical data and archival research between 2012 and 2015 has helped us to shed light on how countries and organisations adapt and resist internationally dominant regulation through the manipulation of regulatory tools (contingent upon country size, the state's ability to accumulate resources, healthcare demands, established traditions of scientific governance, and economic and scientific ambitions).