Properly inform definition12/23/2023 Respect for everyone’s right to self-determination in health care decisions has also involved some specific aspects such as the ability to make choices, the right to obtain a free, prior and informed consent of the party concerned, and the possibility to donate one’s body to medical science after death, a choice that is currently protected by specific laws in much of the world. In Europe, the recognition of the above-mentioned principles may also be found in various documents, most notably the Charter of Fundamental Rights of the European Union providing that: “in the medical field and biology, the following requirements are needed: the free and informed consent by the person concerned, in the manner laid down by law”. Īt the international level, the transposition of this principle can be related to what emerged from the famous Doctors’ Trial held in Nuremberg in 1947 against Nazi doctors, which stated the mandatory consent by the concerned party to undergo health treatments and scientific research protocols. In this case, the court concluded that: “A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment … in discussing the element of risk a certain amount of discretion must be employed consistent with the full disclosure of facts necessary to an informed consent …”. The first time “informed consent” appeared in a medical-related judgment was on Octoin a malpractice judgment from California Court of Appeals-Salgo v. The landmark judgment about the aforementioned judicial matter stated that “… Every human being of adult years and sound mind has a right to determine what shall be done with his own body and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damages …”. One of the first legal cases concerning the acknowledgment of the patient’s right to be informed and to self-determination about his/her health dealt with the American case Shloendorff v. Over time, along with the evolution of medical science, a step forward was made in approaching the physician–patient relationship, leading to the consideration of patients as real decision-makers about their own healthcare and treatments. This attitude relied on a paternalistic doctor–patient relationship until a few decades ago. Previously, patient clinical information was mostly left unspoken of, in accordance with the Hippocratic oath stating that physicians have to reveal nothing to their patients about their future or present clinical condition. It is only in the second half of the last century that the informed consent doctrine became part of various legal systems, having its conceptual origins in the United States at the beginning of the twentieth century. The informed consent doctrine, with particular reference to the field of healthcare, relies on professional ethics-related aspects rather than on purely medical procedures. 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. 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 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. The total amount of compensation paid was EUR 287,144.59. The most involved branches were those related to surgical areas: general surgery, plastic surgery and aesthetic medicine and orthopaedics. Moreover, 80% of the cases concerned the lack of information provided. 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. The review covered all sentences issued by the 13th section of the Civil Court of Rome during the period January 2016–December 2020. The topic of informed consent has become increasingly important in recent decades, both in the ethical-deontological field and as a duty of law.
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