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 n. 3 of 11 January 2018 (Article 2, paragraph 9).
The decree of the Italian Minister of Health on March 2, 2022, by which CEN members are appointed, attributes to the CEN ‘the competences referred to in Article 2, paragraph 10, of the Law n. 3 of 11 January 2018, including the evaluation of aspects relating to EU Regulation n. 536/2014, and any other competence carried out by existing ethics committees up to the moment the decree was issued.
Therefore, CEN is competent for the assessment of the following three types of studies conducted by EPRs and other public bodies of national character:
· clinical trials pursuant to EU Regulation 536/2014;
· clinical investigations of medical devices pursuant to Regulation (EU) 745/2017;
· pharmacological observational studies pursuant to the Ministry of Health Decree of 30 November 2021.
In addition, CEN evaluates protocols of other studies (including: clinical, observational, diagnostic, public health, using human biological material, with environmental ethics implications), carried out at national level by EPRs and other national public institutions.
The CEN currently in place, in office since 02 March 2022, is chaired by Dr. Carlo Petrini, Director of the ISS Bioethics Unit and President of the National Coordination Centre of Ethics Committees.
The CEN has a scientific secretariat and a technical and administrative secretariat.
