Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference.
Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference.
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DOI：
10.1186/s40900-021-00265-2
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发表时间：
2021-05-18
影响因子：
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通讯作者：
Doran P
中科院分区：
文献类型：
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作者：
Coleman E;O'Sullivan L;Crowley R;Hanbidge M;Driver S;Kroll T;Kelly A;Nichol A;McCarthy O;Sukumar P;Doran P
根据药物临床试验质量管理规范和赫尔辛基宣言，研究者有责任确保研究参与者充分知情，以便提供知情同意书。参与者须知页/知情同意书是促进该沟通过程的关键。尽管研究表明，临床研究参与者信息传单/知情同意书在可访问性方面并非最佳，但很少或没有具体的指导。本研究的目的是为学术研究人员和申办者提出并商定一套指南，用于编写可访问和可理解的受试者须知页/知情同意书。文献综述确定了面向患者的文件准备指南。在严格评估后，提取了关键建议，并编写了一套可应用于临床研究的建议参与者信息页/知情同意书。由一组主要利益攸关方组成的专家共识会议对这些建议进行了评估和修正。利益相关者包括研究伦理委员会的成员（包括外行和专家），患者倡导者，经验丰富的临床研究人员，简单的英语编辑和数据保护官员。就最后一套建议达成了共识。共有44条建议获得一致同意，并被分为五类：布局、布局、内容、语言和可读性。这些建议旨在最大限度地为非专业参与者提供无障碍环境，包括阅读困难、识字或算术困难的读者，从而提高知情同意过程的质量。需要进行更多的实证研究，以进一步改善研究参与者的知情同意程序。然而，这些建议是根据当前文献制定的，并已得到专家利益相关者的批准。希望这些建议将有助于研究者和申办者一致有效地制作更易于获取的临床研究参与者信息页/知情同意书。在线版本包含补充材料，可通过10.1186/s40900-021-00265-2获得。研究人员必须确保研究参与者获得有关研究或试验的所有相关信息。这些信息有助于研究人员决定他们是否愿意参加。受试者须知页/知情同意书是潜在研究受试者及其家人和朋友的重要信息来源。然而，参与者信息传单/知情同意书通常不容易让外行读者理解。对于有阅读障碍的读者或那些在阅读或理解数字方面有问题的人来说，它们可能特别困难。为非专业读者设计信息传单，例如关于药物或不同健康问题的传单，有一些指导方针。但是，如果这些指南适用于临床研究参与者信息传单/知情同意书，则对研究人员有帮助。我们寻找并收集了为成人、非专业读者设计和编写信息传单的指导，并检查指导来源是否可靠。然后，我们提出了一些建议，为研究或试验设计和编写信息传单。我们成立了一个专家组，由外行和研究人员组成，他们审查和讨论了这些建议。专家组商定了最后一套建议。我们希望这些建议将有助于研究人员准备受试者须知页/知情同意书，使受试者始终更容易阅读和理解。在线版本包含补充材料，可通过10.1186/s40900-021-00265-2获得。
In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator’s responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process. Although studies have indicated that clinical research Participant Information Leaflets/Informed Consent Forms are not optimal in terms of accessibility, there is little or no specific guidance available. The aim of this research was to propose and agree a set of guidelines for academic researchers and sponsors for preparing accessible and understandable Participant Information Leaflets/Informed Consent Forms. A literature review identified guidance for the preparation of patient-facing documents. Following critical appraisal, key recommendations were extracted and a set of recommendations which can be applied to clinical research Participant Information Leaflets/Informed Consent Forms were prepared. These recommendations were evaluated and amended by an Expert Consensus Conference consisting of a group of key stakeholders. The stakeholders included members of a Research Ethics Committee (both lay and expert), a patient advocate, experienced clinical researchers, a plain English editor and a Data Protection Officer. Consensus was reached regarding a final set of recommendations. 44 recommendations were agreed upon and grouped into five categories: Layout, Formatting, Content, Language and Confirming Readability. These recommendations aimed to maximize accessibility for lay participants, including readers with dyslexia, literacy or numeracy challenges, thereby improving the quality of the consent process. More empirical research is needed to further improve the informed consent process for research participants. However, these recommendations are informed by the current literature and have been ratified by expert stakeholders. It is hoped that these recommendations will help investigators and sponsors to consistently and efficiently produce more accessible clinical research Participant Information Leaflets/Informed Consent Forms. The online version contains supplementary material available at 10.1186/s40900-021-00265-2. Researchers must make sure that research participants are given all of the relevant information about a research study or trial. This information helps research people to decide if they wish to take part. The Participant Information Leaflet/Informed Consent Form is an important source of information for potential research participants and their families and friends. However, Participant Information Leaflets/Informed Consent Forms are often not easy for lay readers to understand. They can be especially difficult for readers with dyslexia or those who have problems with reading, or understanding numbers. There are guidelines available for designing information leaflets for lay readers, for example, leaflets about medicines or different health problems. But it would be helpful for researchers if these guidelines were applied to clinical research Participant Information Leaflets/Informed Consent Forms. We searched for and gathered guidance for designing and writing information leaflets for adult, lay readers and checked to see if the sources of the guidance were reliable. We then put together some recommendations for designing and writing information leaflets for research studies or trials. We formed an expert group, made up of both laypersons and researchers, who reviewed and discussed these recommendations. The expert group agreed on a final set of recommendations. We hope that these recommendations will help researchers to prepare Participant Information Leaflets/ Informed Consent Forms that are consistently easier to for participants to read and understand. The online version contains supplementary material available at 10.1186/s40900-021-00265-2.