Recent attempts to develop and apply digital ethics principles to address the challenges of the digital transformation leave organisations with an operationalisation gap. To successfully implement such guidance, they must find ways to translate high-level ethics frameworks into practical methods and tools that match their specific workflows and needs. Here, we describe the development of a standardised risk assessment tool, the Principle-at-Risk Analysis (PaRA), as a means to close this operationalisation gap for a key level of the ethics infrastructure at many organisations – the work of an interdisciplinary ethics panel. The PaRA tool serves to guide and harmonise the work of the Digital Ethics Advisory Panel at the multinational science and technology company Merck KGaA in alignment with the principles outlined in the company’s Code of Digital Ethics. We examine how such a tool can be used as part of a multifaceted approach to operationalise high-level principles at an organisational level and provide general requirements for its implementation. We showcase its application in an example case dealing with the comprehensibility of consent forms in a data-sharing context at Syntropy, a collaborative technology platform for clinical research.

最近尝试制定和应用数字道德原则来应对数字化转型的挑战，但组织在运营方面存在差距。为了成功实施此类指导，他们必须找到将高级道德框架转化为符合其特定工作流程和需求的实用方法和工具的方法。在这里，我们描述了标准化风险评估工具——风险原则分析（PaRA）的开发，作为弥补许多组织道德基础设施关键层面的操作差距的一种手段——跨学科道德的工作控制板。 PaRA 工具旨在指导和协调跨国科技公司 Merck KGaA 数字道德咨询小组的工作，使其符合该公司的数字道德准则中概述的原则。我们研究如何将这样的工具用作多方面方法的一部分，以在组织层面上实施高级原则，并为其实施提供一般要求。我们在一个示例案例中展示了其应用，该案例涉及临床研究协作技术平台 Syntropy 数据共享环境中同意书的可理解性。