An Ethical Committee for Clinical TrialsTrials was first set up in September 1996 but was superseded by a new Ethics Committee instituted by the Board of Governors (deliberation No 34 of 27 February 2007) in response to the Italian Ministerial Decree of 12th May 2006.
The new Ethics Committee adhered to the "minimum requirements for the setting up, organization and functioning of Ethics Committees for clinical experimentation on drugs" as specified by the Ministerial Directive on Ethics Committee Reorganisation and Procedures, itself based on the Ministerial Decree. The minimum requirements include:
- Independence.The Ethics Committee, whose members must be from various disciplines, must be consulted for any problem of an ethical nature that arises as part of the clinical and research activity of the Institute. The Ethics Committee may ask for the support of the Research and Clinical Development Service of the Besta Foundation.
- Evaluation of the ethical implications of clinical studies. Such studies are proposed by the various Operating Units and Departments of the Besta Institute. The Ethics Committee assesses theses proposal with a view to protecting the rights, safety and wellbeing of all persons participating in clinical studies, in accord with Italian legislation. The Ethics Committee may approve, require modifications to a trial protocol, or not permit the proposed study to go ahead.
The Ethics Committee is composed of 13 members of sufficiently broad experience to adequately assess the ethical and scientific aspects all studies submitted to it, as specified in the relevant documentation. The members were nominated on 1st April 2007, and have a term-of-office of three years. Normally the Ethics Committee meets on the first Wednesday of every month. The current chair is Professor Eugenio Muller.
Technical and Scientific Secretariat services the Ethics Committee.
The Ethics Committee has approved a set of Regulations specifying the responsibilities, functions and procedures of the Ethics Committee and its Secretariat in conformity with Italian legislation.
Clinical study proposals originating from drug companies or researchers at Besta, are first examined by the Technical and Scientific Secretariat which draws up summaries of proposals and makes them available to Committee members before they meet to consider them.
The Ethics Committee
c/o Fondazione IRCCS Istituto Neurologico Carlo Besta
Via Celoria, 11
Technical and Scientific Secretariat: administrative enquiries
c/o Direzione Scientifica
Fondazione IRCCS Istituto Neurologico Carlo Besta
Via Celoria, 11