title: Readability of patient information can be improved.
abstract: BACKGROUND
  The number of participants in medical experiments has declined and consent often rests on perilous ground because the participant information sheet (PIS) on which informed consent rests preserves identification with the expert environment. This study explores to which extent research ethics committee (REC) members appreciate this problem.
  
  
  METHODS
  A retrospective analysis of ten REC applications were subjected to a naïve reading followed by structural analysis to generate themes and subthemes to guide structured REC member focusgroup interviews. This analysis informed a prospective survey where REC members registered terms and phrases posing comprehension barriers to lay receivers.
  
  
  RESULTS
  Main barriers of comprehension were aspects of contents presentation and specialised terminology. Problematic terms centred mainly on epidemiology, design, descriptive and topographic anatomy and physiology, diagnostic procedures and medicines. Contents problems centred on irrelevant and superfluous information and poor presentation.
  
  
  CONCLUSIONS
  The language, structure and format of the PIS should be improved. Avoiding technical jargon or explaining it when it is used, using more common words when they are available and a clearer structure were identified as potential targets of intervention.
  
  
  BACKGROUND
  not relevant.
  
  
  BACKGROUND
  not relevant.
authors.affiliation: Business and Social Science, Aarhus Universitet, Aarhus, Denmark. mpi@asb.dk
authors.forename: Morten
authors.initials: M
authors.lastname: Pilegaard
authors.forename: Hanne Berg
authors.initials: HB
authors.lastname: Ravn
mesh_terms: D003144:Communication Barriers; D032882:Comprehension / Q000941:ethics; D032962:Consent Forms / Q000941:ethics / Q000592:standards*; D003718:Denmark; D026724:Ethical Review; D028744:Ethics Committees, Research; D017144:Focus Groups; D006801:Humans; D011446:Prospective Studies; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D009626:Terminology as Topic