It can be argued that there is an ethical requirement to classify correctly what is known and what is unknown in decision situations, especially in the context of biomedicine when risks and benefits have to be assessed. This is because other methods for assessing potential harms and benefits, decision logics and/or ethical principles may apply depending on the kind or degree of uncertainty. However, it is necessary to identify and describe the various epistemic states of uncertainty relevant to such estimates in the first place. Therefore, this paper aims to develop a category system of different epistemic states of uncertainty which, although not exclusively, is primarily intended to be applied to early clinical trials. It is formed on the basis—and various combinations—of three dimensions of uncertainty that represent certain parts of incomplete knowledge: outcome (type of event), probability (of outcome) and evaluation (assessment of outcome). Furthermore, it is argued that uncertainty can arise from three different sources (the structure of the object of research, the state of the evidence, or individual handling of the research and already existing knowledge). The categories developed are applied to actual examples from gene therapy and genome editing to illustrate that they can be helpful for a more precise definition of the respective uncertainties, especially in the context of risk–benefit assessment. The categories allow a differentiated perspective of decision-making situations from the point of view of incomplete knowledge in general, but particularly, for example, in early clinical research, and may thereby support a more acceptable ethical assessment of potential harms and benefits.

可以争辩说，在决策情况下，尤其是在必须评估风险和收益的生物医学背景下，正确分类已知和未知的内容是道德要求。这是因为根据不确定性的种类或程度，可能会应用其他评估潜在危害和益处的方法、决策逻辑和/或道德原则。然而，有必要首先识别和描述与此类估计相关的各种不确定性认知状态。因此，本文旨在开发一个不同认知不确定性状态的分类系统，虽然不是唯一的，但主要是为了应用于早期临床试验。它是在代表不完整知识的某些部分的不确定性的三个维度的基础上——以及各种组合——形成的：结果（事件类型）、概率（结果）和评估（结果评估）。此外，有人认为不确定性可能来自三个不同的来源（研究对象的结构、证据的状态或研究的个人处理和已有知识）。所开发的类别应用于基因治疗和基因组编辑的实际示例，以说明它们有助于更精确地定义各自的不确定性，尤其是在风险收益评估的背景下。从一般知识不完整的角度来看，这些类别允许对决策情况有不同的看法，但特别是，