Approval application for experimental protocols

The promoter, prior to presenting documents to the Ethics Committee, must gather preliminary feasibility documentation as requested by the Clinical Experimental Office as indicated in the Rules for clinical experimentation. Here it is possible to download the list of necessary documents to present to the Clinical Experimental Office.

The Clinical Experimental Office will answer the Promotor in writing on the said preliminary feasibility step. Thereafter, the Promotor must present a request for study authorisation to the Technical-Scientific Secretariat (interventional or observational). The following documents, where applicable, must be sent in hard and electronic copy (even if uploaded on the OsSC) at least 30 working days before a committee meeting (20 days for amendments): Ethics Committee opinion request, Ethics Committee opinion request for studies with medical devices, Ethics Committee opinion request for observational studies, Ethics Committee opinion request - global form. The following fees are due for protocol assessments as set by the pursuant Regional Committee Resolution.

Clinical Protocol Assessment with issuing of Single Opinion

€ 4,000

Clinical Protocol Assessment (as collaboration center)

€ 2,000

Prospective Observational Study Assessment

€ 2,000

Non-prospective Observational Study Assessment

€ 500

Substantial or Urgent Amendment Assessment (as coordinating EC)

€ 1,500

Substantial or Urgent Amendment Assessment (as collaborating EC)

€ 1,000

Non-substantial Amendment Assessment

€ 500

Membership and methodology

The Ethics Committee is an independent body whose tasks involve assessment, approval and monitoring of clinical experimental protocol, researcher training and consultancy services. The committee is composed of experts from the various fields of biomedical research, health care and groups safeguarding patients’ rights. It protects and promotes respect for human life, from the moment of conception to natural death by taking inspiration from the Charters of Human Rights, recommendation from international bodies, medical deontology and, in particular, the Helsinki Declaration and Good Clinical Practice guidelines.  

Members of the Ethics Committee

President: Claudio Buoni

Alessandro Calisti (pediatrician), Fiorella Gurrieri (genetics expert), Giovanni Marino (local medicine representative), Giuseppe V. La Spina (clinician), Gemma Berta (voluntary work representative), Modesto D’Aprile (clinician), Paolo Pozzilli (biostatistician), Giorgio Minotti (pharmacologist), Giovanni Sironi (pharmacist), Domenica Tassielli (pharmacist, biomedical devices expert), Valentina Pepe (pharmacist), Norberto Silvestri (Hospital Administrator), Giuseppe La Monaca (legal matters expert), Maddalena Pennacchini (bioethics expert), Daniela Tartaglini (healthcare professions representative), Sara Emerenziani (nutrition expert), Salvatore Sciuto (clinical engineer), Francesco Di Matteo (clinical expert in diagnostic procedures and invasive techniques), Massimo Ciccozzi (biostatistician).