title: Research participant information sheets are difficult to read.
abstract: Written information for potential research participants should be easy to read to enable comprehension and facilitate informed choices. We conducted an analysis of the parent information sheets for 74 research studies involving children. Readability was assessed using the Flesch Reading Ease (FRE) score. The mean FRE was 53.54 (reading age of 15.88 years) and FRE did not differ based on study characteristics. These findings suggest that the reading level of research participant information sheets is above recommended levels. Researchers should routinely compute the reading ease of study information sheets and make greater efforts to improve readability of written documents for potential participants.
authors.affiliation: Institute of Child Health & Great Ormond Street Hospital for Children NHS Trust, Level 7, Old Building, Great Ormond Street, London WC1N 3JH, UK. linda.franck@ich.ucl.ac.uk
authors.forename: Linda
authors.initials: L
authors.lastname: Franck
authors.forename: Ira
authors.initials: I
authors.lastname: Winter
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000592:standards; D032882:Comprehension; D032962:Consent Forms / Q000592:standards*; D006801:Humans; D033282:Parental Consent; D006113:United Kingdom