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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
  1. Virginia Sanchini1,2,3,
  2. Michele Reni4,
  3. Giliola Calori5,
  4. Elisabetta Riva5,
  5. Massimo Reichlin6
  1. 1SEMM – European School of Molecular Medicine, Milan, Italy
  2. 2IEO – European Institute of Oncology, Milan, Italy
  3. 3Department of Health, University of Milan, Milian, Italy
  4. 4Department of Medical Oncology, San Raffaele Scientific Institute, Milan, Italy
  5. 5Clinical Trials Office, San Raffaele Scientific Institute, Milan, Italy
  6. 6Faculty of Philosophy, Vita-Salute San Raffaele University, Milan, Italy
  1. Correspondence to Virginia Sanchini, Department of Experimental Oncology, European Institute of Oncology (IEO), IFOM-IEO Campus, Via Adamello 16, Milan 20139, Italy; virginia.sanchini{at}


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.

  • Autonomy
  • Informed Consent
  • Ethics Committees/Consultation
  • Research Ethics

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