Ethical committee

The Ethical Committee of the Istituto Ortopedico Rizzoli is an indipendent body in charge of ensuring the protection of rights, safety and well-being of the subjects involved in a clinical study and of providing public ensurance of such protection. For this purpose it assesses the scientific, clinical and ethical aspects of experiments and moreover any problematic aspect linked with bioethics that could emerge from assistential and research activities carried out in the Institute.
The Ethical Committee performs the following functions:

  • The octagonal cloister of the monastery of San Michele in Boscoassessment, approval and monitoring of the clinical study protocols, in accordance with articles 4 and 5 of the Ministerial Decree 12th May, 2006 "Minimum requirements for the setting up, organization and working of Ethic Committees for clinical experiments with drugs"; with point 3 of the Attachment 1 to the Ministerial Decree 15th July, 1997 (and following variations), which includes the European Union Guidelines of Good Clinical Practices (GCP) and with point 3 of the Attachment 1 to the Ministerial Decree 18th March, 1998 (and following varations) on "Reference guidelines for the setting up and working of ethical committees";
  • training/updating in order to foster and promote breath spaces, information and ethical awareness within the Institution and among its several components, by means of meetings, seminars and study groups;
  • advising the Administration and Scientific Board of the Institute and anyone in need of information on ethical matters with regards to scientific, healthcare, didactic and administrative issues, with the aim of safeguarding the values of the more vulnerable members of society, in accordance with point 3 of art. 1 of the Ministerial Decree 12th May, 2006.

The Ethical Committee is composed according to the indications provided by the Law 189/2012, the Ministerial Decree of May 12th, 2006 and the Ministerial Decree of February 8th, 2013.

With the resolution n. 271 of June 19th, 2013, the Institute has appointed the components of the Ethical Commettee, who remain in office for three years starting from July 1st, 2013.

NB: regarding the clinical studies needing the on-line registration in the Italian Osservatorio delle Sperimentazioni Cliniche dei Medicinali (OsSC), we highlight that the on-line form must be filled only once the acceptation of the Scientific Director has been acquired.
Content updated 21/09/2017 - 12:55
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