The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the clinical trial protocol, the suitability of the investigators involved in the trial and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.
The main reference for the decisions and the general activity of an Ethics Committee is constituted by the Declaration of Helsinki (in its latest version) and the Convention of Oviedo. Secondly, the recommendations of the National Bioethics Committee are relevant. As for trials of medicinal products it is expected to refer to the rules laid down by the Good Clinical Practice in its latest version. An obvious reference are also the national and international laws according to the updated guidelines of the European Agency for the Evaluation of Medicinal Products concerning the evaluation of the effectiveness of clinical trials. Finally, they will also be considered as a valid scientific-methodological reference the feedback from existing scientific biography on the subject of investigation.
The purpose is to ensure:
The Article 3 of the Italian Law of 12 May 2006 defines the guarantees that must be met for it to be recognized independence of the Ethics Committee. Conditions:
Prof. Bartolomeo Sammartino, President
Prof. Francesco Cappello, Secretary
Avv. Antonio Congedo, Member
Dr. Antonina Sidoti, Member
Dr. Fedele Termini, Member
Prof. Aldo Gerbino
Dr.ssa Virginia Coda Nunziante
Dr. Pier Luigi San Biagio
Don Giuseppe Di Giovanni