ISS, March 23, 2022
The 'National Ethics Committee for the trials of public research organizations (EPR) and other public entities of national character', established by the Minister of Health with a decree of February 1, 2022, pursuant to Law No. 3 of January 11, 2018 (art. 2, paragraph 9), took office today at the Istituto Superiore di Sanità. The Committee has competence for clinical trials, as well as "any other competence until now carried out by existing ethics committees". The new body replaces the ISS Ethics Committee in office until now, maintaining all its functions, to which new competences are added for all research bodies and public bodies of a national nature.
Carlo Petrini, Director of the Bioethics Unit and President of the National Coordination Center of Ethics Committees, has been elected President of the Committee, while the Vice-President is Guido Carpani, Director General of the Federation of Italian Pharmacists Orders.
The Committee
The establishment of the Committee is part of a broad review of the organization of Ethics Committees and the regulatory framework of clinical trials. This revision, already provided for by the above-mentioned law, is now being implemented, especially in order to align Italy with Regulation (EU) 536/2014 applied since January 31 u.s.
With a decree of March 2, 2022, the Minister of Health appointed the members of the National Ethics Committee.
In addition to President Carlo Petrini and Vice President Guido Carpani, the components are:
- Dr. Aurelio Filippini, coordinator area continuing education development and research DAPSS, ASST Sette Laghi Azienda Ospedale di Circolo and Fondazione Macchi;
- Dr. Rosaria lardino, patient representative, President of The Bridge Foundation;
- Prof. Raffaele Landolfi, internist and hematologist, Catholic University of Sacred Heart in Rome;
- Dr. Giovanni Maga, expert in molecular biology, National Research Council;
- Dr. Andrea Manto, expert in bioethics, Higher Institute of Religious Sciences "Ecclesia Mater" in Rome;
- Dr. Roberta Marcoaldi, expert in medical devices, Notified Body 0373 of the National Institute of Health;
- Dr. Francesca Menniti Ippolito, statistics expert, Center for Research and Preclinical and Clinical Evaluation of Medicines, Istituto Superiore di Sanità;
- Dott.ssa Luisa Minghetti, expert in preclinical and translational research, Istituto Superiore di Sanità;
- Dr. Patrizia Popoli, pharmacologist, Center for Preclinical and Clinical Drug Evaluation and Research, Istituto Superiore di Sanità;
- Dr. Antonia Ricci, Director General of the Istituto Zooprofilattico Sperimentale delle Venezie;
- Brig. Gen. Roberto Rossetti, Medical Director of the Policlinico Militare in Rome;
- Dr. Arrigo Schieppati, nephrologist, consultant at the Department of Rare Diseases of the Mario Negri Institute;
- Dr. Marco Silano, Director of the Operational Unit of Food, Nutrition and Health of the Department of Food Safety, Nutrition and Public Health, Istituto Superiore di Sanità.
