Department of Biomedicine and Prevention, University of Rome "Tor Vergata", 00133 Rome, Italy.
Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.
Int J Environ Res Public Health. 2023 Jan 24;20(3):2118. doi: 10.3390/ijerph20032118.
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.
知情同意的话题在最近几十年变得越来越重要,无论是在伦理义务领域还是作为法律义务。本综述涵盖了罗马市民法院第 13 庭在 2016 年 1 月至 2020 年 12 月期间发布的所有判决。在此期间,共发现 156 项判决需要违反同意,其中 24 项证明存在具体责任,并对相应的赔偿进行了清算。此外,80%的案件涉及信息提供不足。涉及的主要科室为与外科相关的科室:普通外科、整形外科学和美容医学以及矫形外科。支付的总赔偿额为 287,144.59 欧元。所进行的研究表明,在广泛的判例法背景下,如何考虑与知情同意权相关的侵犯行为造成的损害,并如何影响对损害赔偿的经济补偿。此外,它表明,受信息不足影响最大的领域是与外科活动执行有关的领域,这些领域具有更大的侵入性和发生不良事件的更高风险。所报告的数据强调需要将知情同意视为不仅仅是一种文件主张,而是作为有效治疗联盟构建的重要时刻,这也有助于避免对全球医疗保健系统来说日益繁重的不必要诉讼。