Corpora of patient information sheets and consent forms for UK cancer trials 2007-2017

Obtaining informed consent is an ethical imperative when conducting research involving human participants. However, participants’ actual level of understanding is often difficult and impractical to assess in operational research. One setting where the stakes for understanding are high due to the potential consequences of research participation is randomised controlled trials (RCTs), which test the effectiveness and safety of medical treatments. However, ethics committees' gatekeeping mechanisms often mean that legalese is mandated in consent forms, which can work against patients’ understanding. The goal of this text-based study was, therefore, to build and analyse a corpus of patient information sheets (PIS) and consent forms (CF) from RCTs conducted in the UK.This data collection consists of 27 participant information sheets and 23 consent forms freely available on-line. Materials were collected following a comprehensive search for publicly available ethical materials from randomised control trials (RCTs) targeting cancer (2007-17), primarily by systematically searching key on-line databases and monograph series. These corpora, which are different, to our knowledge, than any existing collection of medical English, could further research on information provision for patients in RCTs specifically and in healthcare settings more generally, in addition to advancing the study of the language of written ethical documents. Secondary analyses of these data could be undertaken using techniques from corpus linguistics, computational linguistics, and/or discourse analysis, for example, to investigate the nature and complexity of the language used and/or broach participants’ understanding of ethical principles or preference for how different language functions are expressed. All ethical materials that comprise the corpora were freely obtained from the public domain via the web searches described. The ethical material that make up these corpora were drawn from a total of 28 distinct RCTs. The data and metadata are free to download (open access) on the UK Data Archive's ReShare without needing to register on the site at the following link: http://reshare.ukdataservice.ac.uk/853933/Citation: Isaacs, Talia and Murdoch, Jamie and Demjén, Zsófia and Stevenson, Fiona (2019). Corpora of patient information sheets and consent forms for UK cancer trials 2007-2017. [Data Collection]. Colchester, Essex: UK Data Service. 10.5255/UKDA-SN-853933在涉及人类受试者的研究中，获取知情同意是一项伦理义务。然而在实际研究工作中，往往难以且不切实际地评估参与者的实际理解程度。由于研究参与可能带来潜在后果，随机对照试验（randomised controlled trials, RCTs）便是这类对理解程度要求极高的场景之一——这类试验用于检测医疗手段的有效性与安全性。但伦理委员会的把关机制通常要求同意书使用法律措辞，反而可能阻碍患者的理解。 因此，本项基于文本的研究旨在构建并分析英国境内开展的随机对照试验中，患者信息单（patient information sheets, PIS）与同意书（consent forms, CF）的语料库。本次数据集包含27份患者信息单与23份同意书，均可在线免费获取。研究人员通过系统检索核心在线数据库与专著系列，全面搜索2007至2017年间针对癌症的随机对照试验的公开伦理材料，以此收集上述资料。 据我们所知，这些语料库不同于现有所有医学英语语料集，除可推动书面伦理文件的语言研究之外，还能进一步助力针对随机对照试验中患者信息供给、乃至更广泛医疗场景下的信息传递相关研究。此外，可借助语料库语言学（corpus linguistics）、计算语言学（computational linguistics）及话语分析（discourse analysis）等技术对本数据集开展二次分析，例如探究所用语言的特征与复杂程度，或是探讨参与者对伦理原则的理解情况，抑或是对不同语言功能表达方式的偏好。 构成本语料库的所有伦理材料均通过前文所述的网络检索，从公共领域免费获取。本语料库的伦理材料源自总计28项独立的随机对照试验。 本数据集及其元数据可免费下载（open access，开放获取），无需在网站注册，下载链接为：http://reshare.ukdataservice.ac.uk/853933 引用格式：Isaacs, Talia、Murdoch, Jamie、Demjén, Zsófia、Stevenson, Fiona（2019）。《2007-2017年英国癌症试验患者信息单与同意书语料库》[数据集]。埃塞克斯郡科尔切斯特：英国数据服务中心。DOI:10.5255/UKDA-SN-853933