Hastings Cent Rep. 2018 Jan;48 Suppl 1:S70-S77. doi: 10.1002/hast.822.
For many innovations, oversight fits nicely within existing governance mechanisms; nevertheless, others pose unique public health, environmental, and ethical challenges. Synthetic artemisinin, for example, has many precursors in laboratory-developed drugs that emulate natural forms of the same drug. The policy challenges posed by synthetic artemisinin do not differ significantly in kind from other laboratory-formulated drugs. Synthetic biofuels and gene drives, however, fit less clearly into existing governance structures. How many of the new categories of products require new forms of regulatory oversight, or at least extensive forms of testing, remains unclear. Any effort to improve the governance of synthetic biology should start with a rich understanding of the different possible science-policy interfaces that could help to inform governance. CBA falls into a subset of the overall range of possibilities, and which interface is appropriate may turn out to depend on context, on the demands of the decision at hand. In what follows, we lay out a typology of interfaces. After that, we turn to the question of how to draw upon the range of possible interfaces and effectively address the factual and moral complexities of emerging technologies. We propose a governance model built around structures that we call "governance coordinating committees." GCCs are intended to be mechanisms for accommodating the complexities of innovations that have far-ranging societal impacts. The production of biofuels, for example, could contaminate water supplies and have a destructive environmental impact if not managed correctly. The introduction of a gene drive could have economic and environmental impacts that are not restricted to one nation. Forging appropriate means for determining and evaluating those societal impacts, to the best of a corporation's, industry's, or government's ability, is central to responsible research and innovation. Public policy must be shaped in a manner that accommodates as many concerns as possible and minimizes risks.
对于许多创新,监督可以很好地纳入现有的治理机制;然而,其他创新则带来了独特的公共卫生、环境和伦理挑战。例如,合成青蒿素在实验室开发的药物中有许多前体,这些药物模拟了同一药物的天然形式。合成青蒿素带来的政策挑战在本质上与其他实验室配方药物没有显著区别。然而,合成生物燃料和基因驱动装置不太符合现有的治理结构。有多少新类别的产品需要新形式的监管监督,或者至少需要进行广泛的测试,目前还不清楚。任何改进合成生物学治理的努力都应该从对不同的科学政策接口的深入了解开始,这些接口可以为治理提供信息。CBA 属于整体可能性范围的一个子集,合适的接口最终可能取决于背景,取决于当前决策的要求。在下面,我们列出了接口的类型学。之后,我们转向如何利用各种可能的接口,并有效地解决新兴技术的事实和道德复杂性的问题。我们提出了一个治理模型,该模型围绕我们称之为“治理协调委员会”的结构构建。GCC 旨在成为适应具有广泛社会影响的创新的复杂性的机制。例如,如果生物燃料的生产管理不当,可能会污染水源并对环境造成破坏性影响。基因驱动装置的引入可能会对一个国家以外的经济和环境产生影响。尽公司、行业或政府的能力确定和评估这些社会影响的适当方法,是负责任的研究和创新的核心。公共政策必须以一种尽可能容纳尽可能多的关切并最小化风险的方式制定。