National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions (CEN)
Instructions for submission of studies NOT according to European Regulation 536/2014.
For studies according to the European Regulation 536/2014 the site is under construction. For these types, please contact the Scientific Secretariat of the National ethics committee (CEN) at email@example.com.
The evaluation request must be addressed to the National ethics committee (CEN) through a letter signed by the Principal Investigator. The request and the documentation required for the evaluation can only be sent in electronic format to the EC Secretariat (firstname.lastname@example.org).
The evaluation request must contain the following information:
- title of the research;
- indication if the study is multicentric
- name of the Principal Investigator (if the study is multicentric, the name of the person primarily responsible must be indicated) and affiliation(s)
- funding body or sponsor (s)
- list of attached documents
The documents to be attached are:
- (All. A) - Study protocol with version number and date
- (All. B) - Summary of the protocol
- (All. C) - List of centres involved and their local coordinators, if the study is multicentric
- (All. D) - Patient information sheet and informed consent form with version number and date
- (All. E) - Personal data processing information forms with version number and date
- (All. F) - Curriculum vitae of the Principal Investigator and list of publications relevant for the study proposed
In Europe, any study involving the processing of personal data must be carried out in compliance with the provisions of the European Data Protection and Privacy Regulation (EU Reg. 2016/679 - G.D.P.R.).
Only non-personal, or anonymised, data are released from the requirements of the Regulation.
So-called "pseudonymised" data qualifies as personal data as it is possible to re-identify the subject.
The Data Controller, defined as "the natural or legal person, public authority, service or other body which alone or jointly with others determines the purposes and means of the processing of personal data" (Art. 4. par. 1, no. 7 GDPR), shall carry out this conformity assessment prior to the submission of the project to the Ethics Committee, assisted by the Data Protection Officer (D.P.O.) of the Structure/Centre/Institution.
Methods of payment
A fee of €1,000 will apply to submissions made by structures external to ISS, any time a full evaluation of a study is requested.
The methods of payment are:
Beneficiary: Istituto Superiore di Sanità - Viale Regina Elena 299 - 00161 - Rome
BANCA INTESA SAN PAOLO
Filiale di Roma 14
Via Alessandria, 160/A
IBAN: IT13 K 03069 03219 100000300001
Swift code: BCITITMM
For public bodies and organisations with a single treasury system, please use the account of the Central Treasury - Bank of Italy, under the name of Istituto Superiore di Sanità:
Before proceeding with the payment, please contact Susanna Tamiozzo, Ethics Committee Secretariat: e-mail email@example.com; phone n. +39 06 4990 4022
Vocabolario Comitato eticoRichiesta di valutazione