The most recent progresses in international and Italian legislations on bioethical evaluation of clinical studies.

Abstract

Following a brief historical excursus of the legislation concerning pharmaceutical products which has been adopted in the European Union and acknowledged by Italy, this paper describes more recent legislation for evaluating the ethical review of clinical trials (drug studies conducted on humans subjects after completion of drug testing on animals). In particular, the Author takes into account the new European regulations of Good Clinical Practice (GCP) and the impulse that they have given to the legislation in Italy with regards to the “informed consent” and the constitution and the role of the Ethics Committees. Moreover, the further developments of Italian legislation are discussed. This paper is so a review of this topic. Certainly, at present, in Italy, many progresses have been achieved in the transposition of the Communitary law into the National rights especially in the field of the clinical experimentation on human subjects, but some more work should be performed to cover wider needs in many other fields of the scientific research in general.