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述评:新兴技术监督:研究、监管和商业化。

Commentary: Emerging technologies oversight: research, regulation, and commercialization.

机构信息

Humphrey Institute at University of Minnesota, USA.

出版信息

J Law Med Ethics. 2009 Winter;37(4):587-93. doi: 10.1111/j.1748-720X.2009.00432.x.

DOI:10.1111/j.1748-720X.2009.00432.x
PMID:20122101
Abstract

This paper reviews the paper by Kuzma, Najmaie, and Larson that looks at what can be learned from the experience with genetically engineered organisms for oversight of emerging technologies more generally. That paper identifies key attributes of a good oversight system: promoting innovation, ensuring safety, identifying benefits, assessing costs, and doing so all while building public confidence. In commenting on that analysis, this paper suggests that looking at "oversight" in three phases - research and development, regulatory review, and market acceptance - can help to determine when certain of these attributes should take precedence over others and how to structure remedies when an error occurs. The result is an approach that is precautionary with respect to research and development, prudent and open to public input in the regulatory review stage, and purposefully persuasive once market acceptability is at stake, with remedies that are risk-containing in the first phase, risk-managing in the second, and risk-assuaging in the third. Combining the key attributes with the idea of three phases can help attune oversight to society's needs.

摘要

这篇论文回顾了库兹马、纳贾米和拉尔森的论文,该论文探讨了从对新兴技术的监督的角度来看,从基因工程生物体的经验中可以学到什么。该论文确定了一个良好监督系统的关键属性:促进创新,确保安全,识别效益,评估成本,同时建立公众信心。在评论该分析时,本文提出,将“监督”分为三个阶段——研究与开发、监管审查和市场接受——可以帮助确定在某些情况下,这些属性中的某些属性应优先于其他属性,以及在出现错误时如何构建补救措施。其结果是一种在研究与开发方面采取预防措施的方法,在监管审查阶段审慎并对公众意见持开放态度,一旦涉及市场接受度,就具有明确的说服力,并在第一阶段采取风险控制措施,在第二阶段进行风险管理,在第三阶段进行风险缓解。将关键属性与三个阶段的概念相结合,可以帮助使监督适应社会的需求。

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