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Ethics Committee

Home / Science and Research / Ethics Committee

The Ethics Committee (EC) is inspired by the values and founding principles of the Università Cattolica del Sacro Cuore, where it was established in 1988 and today, with the establishment of the Fondazione Policlinico Universitario A. Gemelli Institution, it wants to be an even more integrating service in clinical and health care work to achieve excellence in the care of every person who is a guest and a user of our facilities. The EC is an advisory body, whose members come from different areas of experience. They are mainly asked to assess the ethical conditions of testing protocols and to verify that safety, integrity and rights of the patients involved are safeguarded. The aims of the Ethics Committee can be traced back to three main directions:

  • Ensuring the respect of life – from conception to natural end, taking account of health and rights of the person in the context of clinical practice and research;
  • helping patients in their choices and facilitating the collaboration with patients in the informative-deliberative process, especially in particularly difficult cases;
  • overcome the fragmentation and the complexity of medical specialties through their reading in the anthropological unity of the human person and in particular of the suffering person, in the aim of the best quality of health care and research.

Finally, our Ethics Committee is one of the seven ethics committees authorized by the Lazio Region, according to the DM 08/02/2013 (GU n.96 of 24/04/2013) which has introduced new criteria for the composition and the functioning of the ethical committees.

Location and Contacts of the Ethical Committee

The Scientific and Technical Administration Office is located at the ex Collegio Ioanneum, situated on the 1st  floor, room 221 of the Agostino Gemelli University Hospital Foundation IRCCS – Catholic University of the Sacred Heart

OFFICE HOURS: Mon – Thurs  8 am / 4 pm,  Fri 8 am / 2 pm

TEL 06 3015.5556 06 3015.6124
EMAIL: comitato.etico@policlinicogemelli.it
ADDRESS: Largo Francesco Vito, 1 – 00168 Roma

Members – List of Members of the Ethics Committee 2018 – 2021 Download

Calendar of part-session 2020\2021 Download

Rates and Bank Details Download

Regulations Download

Useful Documents – Clinical trial

IRCCS PRE-ASSESSMENT FOR NO-PROFIT STUDIES

Commission for pre-assessment of the IRCCS Scientific Direction
Procedure Download Evaluation form Download

SPECIFIC CENTER FORMS

If you are looking for the Specific Center Form for Promoter Type (Profit – No Profit – No Profit Co-financed) visit the dedicated page Dedicated page

GUIDELINES

Guideline to present Amendment Download

Guideline to Reply Download

Guideline to draw up a protocol with genetic material Download

Fertility Policy’s Guideline Download

Guideline for an Insurance Quote Download

SEARCH PROTOCOL’S TEMPLATE

SOP Predictive Models Download

SOP Diagnostic Studies Download

SOP Observational Studies Download

SOP Experimental Studies Download

INFORMED CONSENT’S TEMPLATE

Consent for Parents / Guardians / Legal representatives Download

Consent for capable subjects Download

Consent for Adolescents Download

Consent for Minors Download

Consent for capable subjects for observational study Download

For FPG studies

Consent to personal data processing YES Biobank (FPG Promoter) Download

Consent to personal data processing NO Biobank (FPG Promoter) Download

Consent to personal data processing YES Biobank (FPG Promoter) Download

Consent to personal data processing NO Biobank (FPG Promoter) Download

For UCSC studies

UCSC_ Data processing consent with FPG Experimentation Center and UCSC Promoter_YES Biobank
Download

UCSC_ Data processing consent with FPG Experimentation Center and UCSC Promoter _NO Biobank
Download

UCSC_ Data processing consent with the UCSC Experimental Center and Other Promoter_YES Biobank
Download

UCSC_ Data processing consent with UCSC Experimental Center and Other Promoter_NO Biobank
Download

For the studies presented before GDPR EU2016 / 679 (25/05/2018)

Information on data processing (FPG Promoter) Download

Information on data processing (Other Promoter) Download

VARIOUS TEMPLATES

Profit Testing Contracts Template
Profit Download Cofinanziato Download

Study Trend Template
scheda monitoraggio Download tabella deviazioni Download

RSO Form Download

Conflict of interests’ Form Download

Emergency card Download

THERAPEUTIC USE OF MEDICINES OR DEVICES

Therapeutic use of medicines or devices

Guideline Download

Attachments Download

Therapeutic use of medicines

Guideline Download

Attachments Download

REFERENCE STANDARD

Transposition of the EU guidelines. of good clinical practice
Download

Guidelines for the classification and the conduct of observational medicine studies
Download

Implementation of Directive 2001/20 / EC relating to the application of good practice in the execution of. clinical trials of medicinal products for clinical use
Download

Decree of 7th  September 2017, Discipline of the therapeutic use of a medicinal product
Download

Decree of 12/21/2007, How to forward authorization requests to the competent Authority for the communication of substantial Amendments and the Declaration of conclusion of clinical trials and for the requests of Opinion to the Ethics Committee
Download

Devices’ booklet
Download

Minimum requirements for insurance policies to protect subjects participating in medicines’ clinical trials
Download

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