title: Informed consent: towards improved lay-friendliness of patient information sheets.
abstract: Regional research ethics committee (REC) members have voiced a need for the linguistic improvement of informed consent documents to ensure duly informed consent and to ease committee deliberation. We have little knowledge of what elements of language use hamper comprehension, or of the extent of medical researchers' appreciation of this problem and their willingness to accept intervention. This qualitative, explorative study proposes an intervention design and tests its feasibility and acceptability. Semi-structured interviews with potential REC applicants informed a linguistic intervention benchmarked against existing guidelines, mandated locally and nationally, and then evaluated quantitatively in a semi-controlled set-up and qualitatively via questionnaires. Potential applicants professed the psychological acceptability of linguistic intervention. The intervention comprised a downloadable Microsoft Word template outlining information structure, a detailed guideline offering advice for each move and self-selected linguistic screening. It was used by 14 applicants and had a measurable effect on REC deliberation time and approval rates. The intervention instruments overall made it easier for applicants to produce informed consent documents meeting prescribed ethical standards concerning lay-friendliness. In conclusion, it was found that linguistic intervention is relevant, feasible and psychologically acceptable to REC applicants; it aids their text production process and seems to enhance the lay-friendliness of these texts.
authors.forename: Morten
authors.initials: M
authors.lastname: Pilegaard
authors.forename: Hanne Berg
authors.initials: HB
authors.lastname: Ravn
mesh_terms: D032984:Ethics, Research; D007722:Health Knowledge, Attitudes, Practice; D057220:Health Literacy; D006801:Humans; D007258:Informed Consent; D010353:Patient Education as Topic / Q000379:methods*; D036301:Qualitative Research; D012107:Research Design; D035842:Research Subjects