Ministerial Decree of February 8, 2013 has issued a criteria for the composition of Ethical Committees for clinical trials and for their operations (paragraph 11 of Law 189/2012).
With DGR n. 5493 of 25/06/2013, the Lombardy Region has reorganized its network of Ethical Committees for Clinical Trials, allowing the recognition of ethical committees (the EC), their distribution and optimization in the region.
As required by the Decree, Health Director Dr. Luigi Pisani, Scientific Director Dr. Massimo Corbo and Pharmacist Dr. Mariapaola Marconi were appointed members of the EC.
The EC follows the respect for the physical integrity and human health established by Law of 28/03/2001 no. 145 (Official Gazette no. 95 of 24/04/2001).
• Six clinicians (one for each clinical structure + 2 external)
• Territorial general practitioner
• Two pharmacologists
• Pharmacist of the SSR (NHS)
• Expert in legal and insurance matters
• Representative of health professions
• Representative of voluntary associations or patient protection
• Expert in medical devices
Qualification related components:
• Clinical engineer
• Clinical expert in the field related to the study of new techniques and diagnostic therapeutic procedures
Structure related components
When a clinical trial is taking place in the structure, the presence of a Medical Director or his/hers replacement, and/or a pharmacist or his/hers replacement is strictly required. Required components, and those in relation to the qualification, can not be replaced. The term in the office of the members, including the President, is three years, renewable consecutively only once for a total of six years.
Independence of EC
The EC is an independent and multidisciplinary body. The independence of the EC with respect to the institution to which it relates is guaranteed:
• By the lack of the EC hierarchy in the structure where it operates
• By the presence of external members, by not less than one third of the total
• By the absence of conflicts of interest of members of the EC with respect to the proposed clinical trials
• By the absence of economic collaboration between EC members and the companies that promote experimentation, declared in the manner prescribed by the DM 17/12/2004. To this end, members of the EC must annually sign the declaration set out in that DM 02/08/2013 art. 3, paragraph 2, letter c).
The EC, besides having the responsibility of regulating the legislations concerning liabilities of the investigators and the sponsors of the ongoing clinical trials, is also responsible to evaluate:
• Medical Clinical Trials
• Surgical, innovative diagnostics and therapeutic protocols
• Clinical investigations of medical devices
• Observational studies
• Procedures involving the use of human tissue for scientific purposes
• Therapeutic use according to DM 08/05/2003
• Use of medicines for gene therapy and somatic cell therapy outside of clinical trials under D.M. 05/12/2006.
The EC also performs advisory functions related to the ethical issues linked to scientific and welfare activities, in order to protect and promote the human values. The Committee is responsible to set guidance documents and guidelines aimed at promoting the quality of clinical practice and the humanization of medicine, through proper patient information and sensitization of health workers to the respect of ethical values.