title: Animal experimentation in Italy. Legislation and the authorization of research protocols.
abstract: In Italy, the European Directive 86/609/EEC ("The Council Directive on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes") has been given effect with Legislative Decree 116/92, whose main objective is to guarantee the welfare of animals used in research and to prevent unnecessary experiments on animals from being carried out. The regulatory authority for controlling the use of laboratory animals in Italy is the Ministry of Health, which requires that researchers requesting authorization to perform experiments on animals submit not only a copy of the experimental protocol but also a detailed application form that focuses on how the animals will be used. In the evaluation process, the Istituto Superiore di Sanità (Italy's National Institute of Health), in particular, the Service for Biotechnology and Animal Welfare, plays a key decision-making role. The evaluation is conducted by experts in the given area of research and by a veterinarian specifically trained in evaluating experimental protocols involving animal use. In the present work, the evaluation process is explained and a point-by-point description of the application form is provided.
authors.affiliation: Servizio Biologico e per la Gestione della Sperimentazione Animale, Istituto Superiore di Sanità, Rome, Italy. gianluca.panzini@iss.it
authors.forename: Gianluca
authors.initials: G
authors.lastname: Panzini
authors.forename: Rodolfo Nello
authors.initials: RN
authors.lastname: Lorenzini
mesh_terms: D032761:Animal Experimentation / Q000331:legislation & jurisprudence* / Q000592:standards*; D000818:Animals; D000830:Animals, Laboratory; D035843:Biomedical Research / Q000592:standards*; D007558:Italy; D011996:Records