title: Research Ethics Committees and clinical research in Italy: where are we going?
abstract: Italian Ethics Committees (ECs) have entered a new phase because of the recent Law no. 189 of November 8 2012 and the Ministry of Health Decree of February 8 2013. The new norms have introduced important changes. In fact, ECs are now established not to serve a single hospital or research institution but to serve even Regions. Moreover, they are established on the basis of the number of inhabitants, research sites and expected amount of clinical trials. The implementation of the news norms into practice have produced a drastic reduction in the number of ECs. This fact could raise some issues but it could obtain some benefits. The paper explains the main steps of ECs and clinical research development in Italy. Special attention will be paid to recent trends. Moreover, the new norms will be illustrated, showing possible issues and benefits connected to their implementation.
authors.affiliation: Institute of Bioethics, School of Medicine "Agostino Gemelli", Catholic University of the Sacred Heart, Rome, Italy. dsacchini@rm.unicatt.it.
authors.forename: R
authors.initials: R
authors.lastname: Minacori
authors.forename: P
authors.initials: P
authors.lastname: Refolo
authors.forename: D
authors.initials: D
authors.lastname: Sacchini
authors.forename: A G
authors.initials: AG
authors.lastname: Spagnolo
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000639:trends*; D028744:Ethics Committees, Research / Q000639:trends*; D006801:Humans; D007558:Italy