Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, "Sapienza" University of Rome";}.
Section of Legal Medicine, Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, "Sapienza" University of Rome, Rome, Italy.
Acta Biomed. 2021 Sep 2;92(4):e2021072. doi: 10.23750/abm.v92i4.10318.
The following article aims to clarify the guidelines needed for the gaining of informed consent in surgery treatments. Legal dispositions in the provisions of law n. 219/2017, written according to the regulatory mechanism uphold by the Italian Supreme Court and medical code of practice have been properly analyzed in order answer the questions unanswered by the law. Who is supposed to inform the patient? About which risks? Does the patient's characteristics affect information obligation? Is necessary to add more information than those required by the law? How do emergency and urgency affect information obligation? Can the patient give consent in advance to an additional operation during the undergoing surgery, if needed? The answers provided by the law and by the Italian Supreme Court picture a state of obligation, where the single physician risks to encounter several responsibilities. It's important to face this problem inside sanitary facilities, creating a suitable informed consent form and planning surgeries to allow the usage of personal data according to the patient's need.
以下文章旨在阐明手术治疗中获得知情同意所需的指导方针。根据意大利最高法院和医疗实践法规所规定的法律条款 n. 219/2017 中的法律规定,对其进行了适当的分析,以回答法律未涵盖的问题。谁应该告知患者?关于哪些风险?患者的特征是否会影响信息义务?是否需要提供超出法律要求的更多信息?紧急情况和紧迫性如何影响信息义务?如果需要,患者是否可以预先同意在手术过程中进行额外的手术?法律和意大利最高法院的回答描绘了一种义务状态,在这种状态下,单个医生可能会面临多项责任。在医疗机构中面对这个问题很重要,需要创建合适的知情同意书并规划手术,以便根据患者的需求使用个人数据。