Bossert Sabine, Strech Daniel
Institute for History, Ethics and Philosophy of Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
Trials. 2017 Oct 17;18(1):482. doi: 10.1186/s13063-017-2204-0.
The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved.
In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents.
The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC.
In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.
事实证明，制定易于理解的知情同意（IC）文件是人类研究以及医疗环境中最重要的挑战之一。因此，评估和提高理解程度一直是IC实证研究日益关注的问题。然而，在制定易于理解的IC文件方面，仍有一些概念和实际挑战尚未得到解决。
在本文中，我们将概述并系统化其中一些挑战。基于我们在IC文件实证用户测试中的自身经验以及IC中关于理解的相关文献，我们提出了一个用于制定易于理解的IC文件的综合概念模型。
所提出的概念模型整合了不同的方法，用于参与式改进书面信息（包括IC）以及测量IC理解程度的定量方法。
在大多数IC流程中，易于理解的书面信息是有效IC的重要前提。为了提高IC文件的质量，可以应用一个用于测试、修订和重新测试的参与式程序的概念模型。然而，本文提出的模型需要进一步的理论和实证阐述，并澄清几个概念和实际挑战。
