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Updated: Oct 15, 2025

Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
Learning from informed consent litigation to improve practices: A systematic review
Karine Giudici-Wach1, Pierre Gillois2, Thomas Remen3
1University of Lorraine, APEMAC, Faculty of Medicine, 9 avenue de la Forêt de Haye, F-54 505 Vandoeuvre les Nancy CEDEX, France.
Objective:
To describe the reasons that lead judges to qualify malpractice as a lack of information, then rule in favour or not of the health professional (HP).
Methods:
We conducted a systematic review of case law relating to the breach of disclosure obligations over a ten-year period from 2010 to 2020. We used 3 legal databases: Légifrance, Dalloz and Lexis 360, all identified as the most exhaustive.
Results:
Of the 514 law cases included: judges found malpractice owing to lack of information in 377 (73.3%) cases. Among the latter, malpractices were lack of risk information (N = 257, 68.2%), lack of proof of information (N = 243, 64.5%) and/or lack of information on therapeutic alternatives (N = 49, 13.0%). These malpractices resulted in a conviction of the HP in 268 (71.1%) of the cases.
Conclusion:
Case law is an important source of information for improving the quality of HP, lawyers, and judges' practices.
Practice Implications:
This review suggests that.
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