Regulatory innovation in the governance of human subjects research: A cautionary tale and some modest proposals
Regulatory innovation in the governance of human subjects research: A cautionary tale and some modest proposals
复制标题
DOI：
10.1111/j.1748-5991.2007.00025.x
复制
发表时间：
2008-03-01
影响因子：
3
通讯作者：
Burris, Scott
中科院分区：
文献类型：
--
作者：
Burris, Scott
根据被称为“共同规则”的美国法规，联邦政府支持的人体研究必须经过机构审查委员会 (IRB) 的审查。从远处看，共同规则体系似乎是宪法性规制和软法规定的创新实例，但实际上已经发展成为一种自我参照、反应迟钝和墨守成规的官僚机构。本文回顾了对共同规则的批评。它还讨论了为什么该系统无法以高效和有效的方式进行监管，特别指出了IRB与其分配的任务之间的不匹配。谈到改革，文章使用“监管空间”的启发法来描述具有制定标准、监控合规性和纪律违规者能力的实际和潜在监管机构的范围。监管改革由三个概念上的变化构成：认识到IRB作为监督机构的局限性；缩小系统负责控制的风险范围；理清行为标准制定和美德推广之间相互冲突的监管逻辑。文章最后列出了一系列可能的改变，这些改变将使IRB成为一个反应更灵敏的监管者，让更广泛的参与者参与促进美德，将资源集中在更严重的风险上，并解决研究人员不当行为的结构性原因。
Under US regulations known as the "Common Rule," federally-supported human-subject research must be reviewed by an Institutional Review Board (IRB). The Common Rule system from a distance looks like an innovative instantiation of prescriptions for constitutive regulation and soft law, but in practice has grown into a self-referential, unresponsive, and legalistic bureaucracy. This article reviews criticism of the Common Rule. It also discusses why the system fails to regulate in an efficient and effective way, pointing in particular to the poor fit between the IRB and its assigned tasks. Turning to reforms, the article uses the heuristic of "regulatory space" to describe the range of actual and potential regulators with the capacity to set standards, monitor compliance, and discipline violators. Regulatory reform is framed by three conceptual changes: recognizing the limitations of the IRB as an oversight body; narrowing the range of risks the system is tasked to control; and disentangling the conflicting regulatory logics of behavioral standard-setting and virtue promotion. The article concludes with a roster of possible changes that would make the IRB a more responsive regulator, enroll a wider range of actors in the promotion of virtue, focus resources on more serious risks, and address the structural causes of researcher misconduct.