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In Informed Consent Sabine Bossert* and Daniel Strech Bossert and Strech Trials (2017) 18:482 DOI 10.1186/s13063-017-2204-0 RESEARCH Open Access An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent Sabine Bossert* and Daniel Strech Abstract 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. Keywords: Informed consent, Participatory consent improvement, Understanding in informed consent Background methods have been applied to test, improve, and sometimes Informed consent (IC) is an important ethical and legal re- retest understanding in IC. As we will argue below, differ- quirement in research with humans as well as in clinical ent methods should be combined rather than applied inde- care [1–3].TheCouncilforInternationalOrganizationsof pendently to develop understandable IC documents. Medical Sciences, for example, specifies that valid IC can only be given “after providing relevant information about the research and ascertaining that the potential participant Methods has adequate understanding of the material facts” [2]. Only In this paper, we will first argue that it is necessary to clar- if the ‘understanding’ requirement is met can IC be consid- ify the meaning of ‘understanding’ in IC, and propose a ered an effective means to protect participants’ and patients’ working definition of the concept by distinguishing (the autonomy, and to maintain public trust [4–6]. measurement of) ‘subjective’ and ‘objective’ understand- Thus, evaluating and improving understanding has been ing. Secondly, based on the relevant literature as well as of interest for empirical research on IC for several years own experience with participatory improvement of IC [7–9]. However, there seems to be no agreed definition of documents, we aim to systematize a set of methodological the term ‘understanding,’ which makes it difficult to com- issues for the development of understandable IC docu- paretheresultsofdifferentstudies[10,11].Further,various ments. Thereby, we will focus on the engagement of members of the target group in this process. Thirdly, we will propose an integrated conceptual model for testing, * Correspondence: [email protected] Institute for History, Ethics and Philosophy of Medicine, Hannover Medical improving and retesting IC documents. Finally, we shall School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany outline core issues for future research on IC development. © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Bossert and Strech Trials (2017) 18:482 Page 2 of 8 Analysis: conceptual and practical challenges for understanding. For example, if test readers are better ed- the development of understandable consent ucated or more experienced than average members of documents the target population, results on objective as well as sub- In this section we outline five methodological and concep- jective understanding would be biased (higher scores for tual issues for testing and improving understanding in IC. both concepts of understanding compared to the average These are (1) a clarification of the concept of ‘understand- reader). However, such test readers could possibly antici- ing’; (2) explaining the relationship between different ap- pate that it is more difficult for less educated and experi- proaches to empirical research on understanding in IC; (3) enced persons to understand the information given in methodological challenges for the actual revision of IC the tested IC documents. Then, assessing general under- documents; (4) conceptualizing benefits of involving standability could substantially complement data on sub- members of the target population in the evaluation and jective and objective understanding. revision of IC documents; and (5) the identification and In line with this notion, we propose a working definition recruitment of members of the target population for par- for three different types of ‘understanding’ and their con- ticipatory consent improvement. ceptual relationship, which is explained in Table 1. All three types of understanding need to be distinguished Clarification of concepts: ‘subjective’ vs. ‘objective’ from related concepts like comprehension, knowledge, or understanding and general understandability memory, terms that are frequently interchanged. Accord- The first issue for the evaluation and enhancement of ing to our working definition, comprehension can be used ‘understanding’ in IC is to clarify what exactly is to be as a synonym for understanding. We define ‘knowledge’ as evaluated. The lack of an agreed definition of understand- “facts, information, and skills acquired through experience ing in empirical consent research has been criticized before or education”. In other words, we presume readers of IC [12, 13]. The comparison of different studies assessing un- documents to gain some knowledge about certain facts as derstanding requires a common notion of what under- a consequence of having understood these facts. Whether standing actually entails, as well as the application of or not they are able to recall these facts later from their comparable methods [10, 11]. In a systematic review of memories is a question that needs to be addressed separ- studies measuring understanding, Sand et al. [11] show that ately from the concept of understanding. However, ac- several distinct concepts are covered by the term ‘under- cording to our definition, the mentioned concepts are standing’. Despite their varying conceptualizations, all the interrelated – understanding is one prerequisite of gaining studies reviewed by Sand et al. [11] aim to measure under- knowledge, which is one perquisite of memorizing certain standing objectively, i.e., by testing participants’ knowledge pieces of information later on. Of course, this definition is or memory of certain facts. These studies do not generally contestable and needs further consideration to be able to evaluate how well the participants (subjectively) felt them- guide future research on understanding in IC. Irrespective selves to have understood the IC document. of the nature of the definition used, we believe that it is For valid IC, however, IC documents should address prospective research participants’ needs and demands. Table 1 Different concepts of ‘understanding’ Therefore, to improve IC documents it can be helpful to Types of Description Exemplary methods of ‘ ’ first identify text passages that are intrinsically hard to understanding assessment understand. Thus, it is also important to assess readers’ Objective Correct knowledge of Knowledge or memory understanding certain facts after having tests by means of (1) own perception of the documents, e.g., whether they feel read IC documents standardized that they (subjectively) understood the given informa- questionnaires or tion, and whether this information is adequate to come interviews, or (2) by asking participants to to an autonomous decision on their participation. rephrase facts in their Finally, in some cases, it can be advantageous to assess own words general understandability instead of or in addition to ob- Subjective Subjective impression of Open question, e.g., “Do jective/subjective understanding. If, for example, there understanding having understood you think you have are no members of an IC document’s target population certain facts after reading understood the given IC documents information? If not, what available for testing, third parties can be asked to antici- were the text passages pate how difficult it would be for the target population you find difficult to ” at large to understand the given pieces of information. understand? Additionally, members of the target population them- General Personal impression of Open question, e.g., understandability
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