Bioethics Program at Columbia University, USA.
J Law Med Ethics. 2011 Fall;39(3):513-28. doi: 10.1111/j.1748-720X.2011.00618.x.
Institutional Review Boards (IRBs) can play vital roles in observing, monitoring, and responding to research integrity (RI) issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards adopt these roles. I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate=55%), and an additional 12 members and administrators. IRBs become involved in a variety of RI problems, broadly defined, and face challenges in deciding how and when to do so. IRBs vary in how they define, discover, and respond to RI problems, and interact with other institutional offices concerning these issues; and what types of RI violations they encountered. While many institutions establish separate Compliance Offices, the boundaries and relationships between these entities and IRBs vary; and many IRBs discover and monitor RI violations, and struggle with how to respond. Larger questions arise of how IRBs decide whether to trust vs. closely monitor individual PIs. IRBs' roles are often indirect, and not fully systematic, raising questions of whether these functions should be enhanced, and if so, to what degree, and how. These areas require heightened investigation and discussion.
机构审查委员会（IRBs）在观察、监测和应对研究人员的研究诚信（RI）问题方面可以发挥重要作用，但仍有许多问题需要解决，例如这些委员会是否、何时以及以何种方式承担这些角色。我联系了 60 个 IRB（按 NIH 资助的前 240 个机构名单中的每第四个），并采访了其中 34 个（回应率=55%）的领导人，以及另外 12 名成员和管理人员。IRB 广泛参与各种 RI 问题，并面临着决定如何以及何时参与的挑战。IRB 在如何定义、发现和应对 RI 问题方面存在差异，并与其他机构办公室就这些问题进行互动；以及遇到了哪些类型的 RI 违规行为。虽然许多机构设立了单独的合规办公室，但这些实体与 IRB 之间的界限和关系各不相同；许多 IRB 发现并监测 RI 违规行为，并努力应对如何回应。更大的问题是 IRB 如何决定是信任还是密切监督个别 PI。IRB 的角色通常是间接的，且不是完全系统的，这引发了关于是否应该增强这些职能，以及如果需要增强，应该在多大程度上以及如何增强的问题。这些领域需要进一步调查和讨论。
