title: Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.
abstract: We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.
authors.affiliation: SEMM - European School of Molecular Medicine, Milan, Italy.
authors.forename: Virginia
authors.initials: V
authors.lastname: Sanchini
authors.forename: Michele
authors.initials: M
authors.lastname: Reni
authors.forename: Giliola
authors.initials: G
authors.lastname: Calori
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Riva
authors.forename: Massimo
authors.initials: M
authors.lastname: Reichlin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D032882:Comprehension / Q000941:ethics; D032984:Ethics, Research; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007558:Italy; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012108:Research Personnel; D012189:Retrospective Studies; D011795:Surveys and Questionnaires
keywords: Autonomy; Ethics Committees/Consultation; Informed Consent; Research Ethics