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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