Abstract

Despite its undoubted importance, the juridical discipline of clinical experimentation to date is fragmentary and heterogeneous. For the most part, the matter is left either to general principles contained in the Constitution or derived from the Community; or to sources subordinate to the law (with particular reference to ministerial decrees or circulars for implementation). After first reconstructing the uneven normative framework, the author examines the matter of the inviolable rights of the patient as limits to the freedom of clinical experimentation, and above all concentrates on the new models of legal regulation presently being tried out in the complex area of pharmacological experimentation. In this perspective, particular attention is given to the role of the ethical committees, to the nature of their responses and to the possible areas of criminal liability of the members composing them.