An integrated conceptual framework for evaluating and improving 'understanding' in informed consent

被引:14
作者
Bossert, Sabine [1 ]
Strech, Daniel [1 ]
机构
[1] Hannover Med Sch, Inst Hist Eth & Philosophy Med, Carl Neuberg Str 1, D-30625 Hannover, Germany
来源
TRIALS | 2017年 / 18卷
关键词
Informed consent; Participatory consent improvement; Understanding in informed consent; INFORMATION; QUALITY; IMPROVEMENT; TRIAL;
D O I
10.1186/s13063-017-2204-0
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
引用
收藏
页数:8
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