背景:根据良好临床实践和赫尔辛基宣言,它是研究者的责任,以确保研究参与者充分了解,允许提供知情同意。参与者信息传单/知情同意书是促进这一沟通过程的关键。尽管研究表明,临床研究参与者信息传单/知情同意书在可及性方面并不是最佳的,有很少或没有具体的指导。这项研究的目的是为学术研究人员和赞助商提出并商定一套指南,以准备易于理解的参与者信息传单/知情同意书。
方法:文献综述确定了准备面向患者的文件的指南。经过严格的评估,提取了主要建议,并准备了一套可应用于临床研究参与者信息传单/知情同意书的建议。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订。利益相关者包括研究伦理委员会的成员(包括外行和专家),一个病人的倡导者,经验丰富的临床研究人员,一个普通的英语编辑和数据保护官。就最后一套建议达成了共识。
结果:商定了44项建议,并将其分为五类:布局,格式化,内容,语言和确认可读性。这些建议旨在最大限度地提高非专业参与者的可及性,包括有阅读障碍的读者,识字或算术挑战,从而提高同意程序的质量。
结论:需要更多的实证研究来进一步改善研究参与者的知情同意程序。然而,这些建议是基于当前的文献,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人员和赞助者一致有效地制作更容易获得的临床研究参与者信息传单/知情同意书。
研究人员必须确保向研究参与者提供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。参与者信息传单/知情同意书是潜在研究参与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。对于患有阅读障碍的读者或阅读有问题的人来说,它们尤其困难,或者理解数字。有为非专业读者设计资料单张的指引,例如,关于药物或不同健康问题的传单。但是,如果将这些指南应用于临床研究参与者信息传单/知情同意书,对研究人员将有所帮助。我们搜索并收集了为成人设计和撰写信息传单的指南,放下读者,检查指南的来源是否可靠。然后,我们提出了一些建议,用于设计和撰写研究或试验的信息传单。我们成立了一个专家组,由外行人和研究人员组成,他们审查并讨论了这些建议。专家组商定了一套最后建议。我们希望这些建议将有助于研究人员准备参与者信息传单/知情同意书,使参与者始终更容易阅读和理解。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
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.