How does the ethical review process work in Italy and which are the designated ethics committees?

The Ethics Committee is “responsible” for ensuring the protection of the rights, safety and well-being of the people involved in  trials and providing  public guarantee of such protection. (Decree 8 February 2013, Art. 1). With regard to clinical trials on  medicinal products it should:

  • verify the applicability of the proposed trials evaluating their rationale
  • verify the appropriateness of protocols (objectives, design, operation, result evaluation)
  • verify the competence of researchers
  • asses all the ethical aspects, with particular reference to informed consent, protection of confidentiality, the use of biological  samples.

“The competence of each Committee may concern, in addition to clinical trials on medicinal products, any other issue they might  be entrusted with according to international practices. Namely the use of medicines and medical devices, surgical and clinical  procedures or related to studies on food products on humans” (Law 8 November 2012, No. 189, Art. 12).

Ethics Committees are set up in structures identified by the Regions. Each Ethics Committee is in charge of one or more  provinces, in order to comply with the standard of one Committee per million inhabitants, without prejudice to the possibility of  providing an additional Ethics Committee, also competent to act in one or more scientific hospitalization and care institutions  (Law 8 November 2012, n. 189, Art. 5). Where not included in the regional lists, the expertise of some Ethics Committees may also  be recognized due to their national mandate. Among these are the Ethics Committees of the National Institute of Health (Istituto  Superiore di Sanità, ISS) and the “Celio” Military Hospital (Decision of Lazio Region of June 12, 2013).

Regulatory framework of Ethics Committees in Italy

The main current regulations are:

  • Implementation of the European Union guidelines on good clinical practice for trials on medicinal products (Health Ministry,  Decree of 15 July 1997).
  • Legislative Decree 24 June 2003, No. 211 transposing Directive 2001/20/EC concerning the implementation of good clinical  practice in the conduct of clinical trials on medicinal products for human use. An unofficial English translation of this Decree is available.
  • Decree of the Ministry of Health, December 21, 2007, Complete guide on the modalities to request the authorization of a clinical  trial on a medicinal product for human use, the disclosure of substantial amendments and the final declaration to the competent  authority.
  • The Ministerial Decree 8 February 2013 stating the reorganization of Ethics Committees in Italy, member characteristics and  background: so called Decreto Balduzzi.

Weblinks to Italian Ethics Committees