Informed Consent: Legal Obligation or Cornerstone of the Care Relationship?

Margherita Pallocci (), Michele Treglia, Pierluigi Passalacqua, Roberta Tittarelli, Claudia Zanovello, Lucilla De Luca, Valentina Caparrelli, Vincenzo De Luna, Alberto Michele Cisterna, Giuseppe Quintavalle and Luigi Tonino Marsella
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Margherita Pallocci: Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, 00133 Rome, Italy
Michele Treglia: Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, 00133 Rome, Italy
Pierluigi Passalacqua: Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy
Roberta Tittarelli: Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, 00133 Rome, Italy
Claudia Zanovello: Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, 00133 Rome, Italy
Lucilla De Luca: Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, 00133 Rome, Italy
Valentina Caparrelli: Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, 00133 Rome, Italy
Vincenzo De Luna: Department of Clinical Science and Translational Medicine, Section of Orthopedics and Traumatology, University of Rome “Tor Vergata”, 00133 Rome, Italy
Alberto Michele Cisterna: XIII Section, Civil Court of Rome, 00192 Rome, Italy
Giuseppe Quintavalle: Fondazione Policlinico “Tor Vergata”, 00133 Rome, Italy
Luigi Tonino Marsella: Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, 00133 Rome, Italy

IJERPH, 2023, vol. 20, issue 3, 1-10

Abstract: The topic of informed consent has become increasingly important in recent decades, both in the ethical-deontological field and as a duty of law. The review covered all sentences issued by the 13th section of the Civil Court of Rome during the period January 2016–December 2020. During this period, 156 judgments were found in which a breach of consent was required; in 24 of these, specific liability was proven, and the corresponding compensation liquidated. Moreover, 80% of the cases concerned the lack of information provided. The most involved branches were those related to surgical areas: general surgery, plastic surgery and aesthetic medicine and orthopaedics. The total amount of compensation paid was EUR 287,144.59. The research carried out has highlighted how, in a broad jurisprudential context, the damage caused by the violation of the right related to informed consent is considered, and how it impacts on the economic compensation of damages. Additionally, it showed that the areas most affected by the information deficit are those related to the performance of surgical activities, which are characterized by greater invasiveness and a higher risk of adverse events. The data reported underline the exigency to consider informed consent not as a mere documentary allegation but as an essential moment in the construction of a valid therapeutic alliance, which is also useful for avoiding unnecessary litigation that is becoming increasingly burdensome for healthcare systems all over the world.

Keywords: informed consent; malpractice; medical errors; liability; legal; physician–patient relations; communication (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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