The "National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions" (CEN) was established at the Istituto Superiore di Sanità (ISS) by decree of the Italian Minister of Health on February 1, 2022, pursuant to law no. 3 (Article 2, paragraph 9). The decree of the Minister of Health of March 2, 2022, by which the members are appointed, attributes to the CEN the competences referred to in Article 2, paragraph 10, of the Law of 11 January 2018 n. 3, including the evaluation of both aspects relating to EU Regulation no. 536/2014, and any other competence carried out up to the moment the decree was issued by the already existing ethics committees.
Therefore, the CEN is in charge of the following:
- evaluation of clinical trials pursuant to EU Regulation 536/2014 carried out by the ISS, the EPR and other national public institutions
- evaluation of other studies (including clinical, observational, diagnostic, public health, with medical devices, with the use of human biological material, with implications of environmental ethics) carried out by the ISS and, possibly, by other EPR and other national public institutions
- advice and expression concerning the ethical aspects of the activities and interventions of the ISS, in relation to its functions and tasks defined by the Statute of the ISS, the Organization and Functioning Regulations of the ISS and in compliance with current regulations
The current CEN, in office since March 2, 2022, is chaired by Dr. Carlo Petrini, Director of the ISS Bioethics Unit and President of National Centre for Coordination of Territorial Ethics Committees.
The CEN has a scientific secretariat and a technical and administrative secretariat.
The Bioethics Unit deals with bioethical issues in research and institutional activities within the Institute and in relations with external institutions and provides support to CEN's activities.