Italy - RECs and Medical Research

History

There are local ethics committees situated in health facilities or authorised research institutes which were given legal status in the 90s, firstly by a Ministerial Decree of 27 April 1992 and subsequently by a Decree of 15 July 1997. There were already ethics committees in existance but they operated within research institutes on a voluntary basis. More detailed regulations were given by 2 decrees of the MInistry of Health of 18 March 1998. One of these contains guidelines concerning the establishment and operation of ethics committees. The EC Directive 2001/20/EC was implemented by Legislative Decree No. 211 of 23 June 2003. They are supervised by the Ministry of Health.

Regional Bioethics Committees were created in 2000 that act as co-ordinators for local RECs and also provide a link between them and the National Bioethics Committee. In some regions where there is only a regional REC they review research proposals

The National Bioethics Committee was established by a Prime Minister's Decree of 28 March 1990 and it acts as a consultative body of the Council of Ministers. Parliament, research centres, local ethics committees and individuals can approach them for advice. They also assist in preparing legislation.

The National Ethics Committee for Research and Clinical Trials was established by Legislative Decree no.502 of 30 December 1992 and regulated in detail through a Ministerial Decree of 23 November 1999. It advises the Ministry of Health on ethical and scientific issues and is in charge of co-ordinating ethical and scientific review of multi-centre clinical trials of substantial national interest.

Summary of Italian RECs

Type of REC	Local Ethics Committees	Regional Bioethics Committees	National Bioethics Committee	National Ethics Committee for Research and Clinical Trials
Where situated?	Health care facilities & authorised research institutes	all regions	Rome
Who applies to them?	Researchers	In some cases researchers; mostly advisory to regional bodies	Parliament, research centres, local ethics committees and individuals
Formal/Informal	Formal	Formal	Formal	Formal
National/Regional	Regional	Regional	National	National
Laws Involved (see below)	Decree No. 211 of 23 June 2003 Decree 27 April 1992 Decree 15 July 1997 Decree 18 March 1998 Decree 24 June 2003	Constitutional Court Decision 21 December 2000, no.569	Decree 28 March 1990	Legislative Decree no. 502 30 December 1992 Ministerial Decree 23 November 1999
Guidance Involved	Declaration of Helsinki	Declaration of Helsinki	Declaration of Helsinki	Declaration of Helsinki
Membership requirements	2 clinicians 1 expert in bio-statistics 1 pharmacologist 1 pharmacist the medical director or where applicable the scientific director of the Institution 1 legal expert		40 Members designated by Ministers for their biological, legal, scientific or ethic competencies. Within: 4 Members : the Presidents of the National Research Council, the Superior Council for Health, the National Doctors Order, The Superior Institute for Health.
Responsible/accountable to whom?	Ethics Committees are independent. However the Minister of Health may supervise the mechanisms regulating the setting up and functioning of Ethics Committees.		Under the supervision of the Prime Minister.	Ministry of Health
Approval or Advisory powers	Approval in case of processing of genetic data: An authorisation of the Garante after hearing of the Minister of Health must be obtained.	Approval in some instances e.g.regions where they are the only REC. Advisory: Regional bodies may request their advise.	Consultative Role	Advisory
'Mission'	Approving the performance of drug tests Assessing biomedical issues· Supervising training of health care personnel Assessing medical practice issues. Ensuring the protection of rights, safety and well-being of any entity involved in testing (Decree 15 July 1997) Evaluating drugs testing progress reports (Decree 18 March 1998) Evaluating adverse events and inadequate developments of clinical studies (Decree 18 March 1998) Monitoring the communication the sponsor is required to provide (Decree 18 March 1998	They act as a link & co-ordinating entities between local committees & the National Bioethics Committee	Summarising the programs, aims and results or the research and the experimentation in life science and human health sectors. Giving opinion and legal solutions to ethical and legal questions resulting from the progresses of research. Studying the prevention of human and natural area from biological substances and protection of the patients in relation to the new genetic therapies. Writing codes of conduct to inform the public. Studying the heredity and the human genome, the procreation, the human rights in biomedicine, protection of persons in final phase, epistemology.	They advise the Ministry of Health on ethical & scientific issues. They also co-ordinate the ethical & scientific assessment of multi-centre trials that are of substantial national interest.

Not submitting research or failing to follow review

The researchers would be liable for damage and offence resulting from the trials. Moreover, an emergency order could be taken by the Court to prohibit the trial from starting or continuing. (Decree 10 May 2001).

Which body, if not the REC itself takes this action, and how do they proceed?

The REC or the data subject might takes this action.

Impact of Directive 2001/20 EC

The directive has been implemented through Decree No. 211 of 24 June 2003

Legal action that can be taken against RECs

The liability of RECs is a matter for dispute amongst legal scholars in Italy and is as yet unresolved.

Links section

National Bioethics Committee (in Italian & English)
Federazione Nazionale dei Comitati di Etica (National Federation of Ethics Committees -in Italian)
National Monitoring Centre for Clinical Trials (in Italian & English)
Ministry of Health (in Italian)

See the REC bibliography section for more links and papers