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

Virginia Sanchini, Michele Reni, Giliola Calori, Elisabetta Riva, Massimo Reichlin

Research output: Contribution to journalArticle

21 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)269-275
Number of pages7
JournalJournal of Medical Ethics
Volume40
Issue number4
DOIs
Publication statusPublished - 2014

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Informed Consent
Observational Studies
comprehension
Clinical Trials
Phase III Clinical Trials
Neoplasms
Research Personnel
Education
cancer
participation
Observational Study
questionnaire
education

ASJC Scopus subject areas

  • Health Policy
  • Health(social science)
  • Issues, ethics and legal aspects
  • Arts and Humanities (miscellaneous)

Cite this

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AU - Reichlin, Massimo

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