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      Information obligation in surgery

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          Abstract

          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 needs.

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          Informed consent—It's more than a signature on a piece of paper

          Informed consent is an ethical concept that is codified in the law and is in daily practice at every health care institution. Three fundamental criteria are needed for clinical informed consent: the patient must be competent, adequately informed and not coerced. Physician-patient interaction is rooted in the ethical concept of beneficence, but over the 19th and 20th centuries, case law and societal changes brought respect for autonomy and with it--informed consent. This article briefly reviews the basics of informed consent, when is it required, how did informed consent evolve into what it is today and what can the surgeon do to truly achieve informed consent.
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            Informed consent procedures with cognitively impaired patients: A review of ethics and best practices.

            The objectives of this article are to discuss ethical issues of informed consent in cognitively impaired patients and review considerations for capacity determination. We will also discuss how to evaluate capacity, determine competence, and obtain informed consent when a patient is deemed incompetent. This review emphasizes how to carry out informed consent procedures when capacity is questionable and discusses measures supported for use when determining cognitively impaired patients' ability to consent.
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              Stem cell therapy: from evidence-based medicine to emotion-based medicine? The long Italian way for a scientific regulation

              On 23 May 2013, the Italian health minister decided to endorse a law regarding controversial stem cell-based therapies in 32 young terminally ill patients, shocking many scientists. According to the international scientific community, these therapies could be dangerous because they were not rigorously tested in humans. This decision was made after many days of media and judiciary pressure. Several lawsuits regarding stem cell-based therapies were brought before the judiciary districts of different Italian regions. We analyzed the Italian legal context regarding the field of pharmaceutical and medical devices, including the European Union trend. A national database - commonly used to manage legal materials for professional or educational purposes or both - was used to find relevant legal cases involving stem cell-based therapies. Stem cell-based therapies endorsed by the new Italian law have been the subject of an important discussion not only in the scientific community but also in various courts. We found several legal actions filed by parents in order to make stem cells available to their young children, who had serious neurodegenerative diseases. The majority of the analyzed legal disputes were settled in favor of the applicants, whereas only two decisions (Courts of Justice of Rome and Florence) rejected the complaint because of the absence of sufficient scientific data regarding stem cell-based therapies. The present Italian situation is influencing the destiny of future young patients and strongly impacting public and institutional opinion. It is a practical example of the complexity of the decision of not providing unapproved scientific stem cell-based therapies when medicine does not have any other alternative therapies.
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                Author and article information

                Journal
                Acta Biomed
                Acta Biomed
                Acta Bio Medica : Atenei Parmensis
                Mattioli 1885 (Italy )
                0392-4203
                2531-6745
                2021
                02 September 2021
                : 92
                : 4
                Affiliations
                Section of Legal Medicine, Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, “Sapienza” University of Rome, Rome, Italy
                Author notes
                Correspondence: Prof. Natale Mario di Luca, Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, “Sapienza” University of Rome, Viale Regina Elena n. 336, 00161, Rome, Italy; E-mail: natalemario71@ 123456libero.it
                Article
                ACTA-92-72
                10.23750/abm.v92i4.10318
                8477101
                34487102
                98f8d9bf-0996-4906-a781-532ae7c34ea0
                Copyright: © 2021 ACTA BIO MEDICA SOCIETY OF MEDICINE AND NATURAL SCIENCES OF PARMA

                This work is licensed under a Creative Commons Attribution 4.0 International License

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