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Eurecnet - National Information: Italy

National Information: Italy

    Territorial ethics committees and ethics committees of national significance

    In Italy, Law n.3/2018 established a profound reorganization of ethics committees, also in view of the application of Regulation (EU) 536/2014.

    In particular, the law provides for the institution of 40 territorial ethics committees, established with Decree 26 January, 2023 (https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2023-02-07&atto.codiceRedazionale=23A00852&elenco30giorni=true).

    Ethics committees "have the responsibility to guarantee the protection of the rights, safety and well-being of the persons undergoing trials and to provide a public guarantee of such protection".

    The Law n. 3/2018 also provides for the establishment, by ministerial decree, of three ethics committees of national significance, one of which is reserved for pediatric trials. With the decree dated February 1, 2022 of the Minister of Health, the following were established:

    • National Ethics Committee for Clinical Trials of Public Research Bodies (EPR) and Other National Public Institutions, at the Italian National Institute of Health (Istituto Superiore di Sanità) (https://www.iss.it/en/comitato-etico);
    • National Ethics Committee for Clinical Trials in the Pediatric Field, at the Italian Medicines Agency (https://www.aifa.gov.it/en/comitato-etico-per-le-sperimentazioni-cliniche-in-ambito-pediatrico);
    • National Ethics Committee for the Trials of Advanced Therapies Medicinal Products (ATMPs), at the Italian Medicines Agency (https://www.aifa.gov.it/en/comitato-etico-per-le-sperimentazioni-cliniche-relative-alle-terapie-avanzate-atmp-).

    The National Coordination Centre of Local Ethics Committees (https://www.aifa.gov.it/en/centro-coordinamento-comitati-etici)

    With the Law n. 3/2018, the National Coordination Centre of Local Ethics Committees for Clinical Trials Concerning Medicinal Products for Human Use and Medical Devices is also established.

    The National Centre, chaired by Carlo Petrini, has the functions of coordinating, guiding and monitoring the activities of evaluating the ethical aspects relating to clinical trials on medicinal products for human use delegated to the territorial ethics committees.

    Ethics committees for clinical practice

    Some regions have adopted regional regulations for the establishment and operation of ethics committees for clinical practice. In some other Regions, there are ethics committees for clinical practice set up independently by health structures. There is no national legislation to regulate ethics committees for clinical practice.

    Contacts

    National Coordination Centre of Local Ethics Committees
    https://www.aifa.gov.it/en/web/guest/centro-coordinamento-comitati-etici

    Contact: eurec@eurecnet.org