Director of Research, Head of the Bioethics Unit and
Chair of the Ethics Committee
Istituto Superiore di Sanità (ISS, Italian National Institute of Health)
Delegate of the ISS on the National Bioethics Committee
Member of the Pontifical Academy for Life
1. Biographical notes
- Degree in Biological Sciences, 1988 (110/110 with honour and mention. Prize Sgaravatti)
- Qualification to the Biologist Association, 1990
- Post-university specialization in Bioethics
- Cours Universitaires de langue, lettres et civilisation françaises (Université de Paris Sorbonne), 1984 (with honour)
- Prize Superior School of Journalism in Venice Mestre - Centre Kolbe
- Prize Atheste - Education Superintendency of Padua
- 2005-2022: Senior researcher, ISS
- 1993-2005: Research assistant, ISS
- 1988-1993: Scholarships and contracts, ISS
2. Institutionary appointments
COMMISSIONS, COMMITTEES AND OTHER INSTITUTIONARY APPPOINTMENTS
1) Appointment from the Council of Europe:
- Since 2016: Member of the “Ad hoc working group on the prohibition of making a financial gain from the human body” for the correct interpretation of art. 21 of the “Convention on Human Rights and Biomedicine" of the Council of Europe
2) Appointment from the Minister for Health:
- National Ethics Committee for clinical trials of public research bodies (EPR) and other public bodies at the national level (at the ISS) (Decree of Minister for Health 2 March 2022) - Chair
- 2020: Member of the “Medicines – CoViD-19” (Decree of the President of ISS 11 March 2020, n. 45)
- Since 2019: Member of the Working Group "Regulation for the management of conflict of interests" (Decree of the President of the Italian National Institute of Health n. 55/19 of 7 November 2019)
- Since 2019: Member of the Working Group of the National Institute of Health foreseen in the legislative decree 14 May 2019 n. 52 ("Implementation of the delegation for the reorganization and reform of the legislation on clinical trials of medicinal products for human use, pursuant to article 1, paragraphs 1 and 2, of the law 11 January 2018, n. 3") and in charge of identify “homogeneous criteria for the use of biological samples [for research purposes] taking into account the methods of access and acquisition of the patient's consent on the subsequent use of the sample taken” (art. 1, point 2, paragraph b)
- Since 2018: Delegate of the ISS on the Ministry for Health for the drafting of the Ministerial decrees putting the law 11 January 2018 n. 3 (Ethics Committees and clinical trials) into effect
- Since 2016: Responsible for the “Ethics” area of the “Website of knowledge” of the ISS
- Since 2006: Member of the National Commission for the Program of Crossover Kidney Transplant
- Since 2006: Member of the Interdepartmental Commission on Oncology of ISS
- Since 2005: Member of the Ethics Committee of the Neurological Institute Casimiro Mondino
- Since 2005: Member of the Working Group on the living donor crossover kidney transplant (Italian National Transplant Centre)
- Since 2004: Member of the Ethics Committee of ISS (2014-2017: Vice-President: since 2017: President)
- Since 2004: Member of the Ethics Committee of the Mediterranean Institute of Haematology
- Since 2004: Advisor of the United Nations Educational, Scientific and Cultural Organization (UNESCO) for the disciplinary area: Bioethics
- Expert for the Joint Commission (2009-2010) (Decree of the President of the Council of Ministers 17 February 2009)
5) Appointment from the Italian National Health Council:
- Member of the Working Group “Medical Humanities in the era of technological and IT medicine” (2018)
6) Appointment from the President of the National Agency for New Technologies, Energy and the Sustainable Economic Development (ENEA):
- Since 2003: Member of the Bioethics Committee of ENEA
7) Appointment from the Director of the Italian National Transplant Centre:
- Member of the Working Group "Anonymity constraint" for reform and updating of law 1 April 1999 no. 91 "Provisions regarding the removal and transplantation of organs and tissues" (Decree of the Director of the National Transplant Center March 17, 2022 n. 22)
- Member of the Permanent Table on Dementia of the Ministry of Health (Decrees: 11 February 2021, 15 June 2022).
- Member of the Scientific Committee of the Health Festival, Siena 12-15 November 2020
- Member of the Ethics Think Tank “Synthetic Biology”, National Centre of Competence in Research (NCCR) Molecular Systems Engineering, University of Basel
- Member of the Technical-Scientific Committee of the Clinical Guidelines for the Tretatment of Tobacco and Nicotine Addiction (ISS)
- Member of the Experts Panel of Guidelines for Physiological Pregnancy (ISS)
- Advisor to the Expert Panel of the Guidelines on Major Traumas for ethical issues and the management of conflicts of interest (ISS)
- Chair of the Expert Panel on end-of-life care. Azienda Ospedaliera San Giovanni Addolorata, Rome
- Member of the Scientific Committee of the master “Human ecology and life sciences: third millennium sustainability challenges” (Scuola di Alta Formazione e Studi Specializzati per Professionisti, Università Campus Biomedico di Roma, Università di Bari, Fédération Internationale des Associations de Médecins Catholiques - World Federation of the Catholic Medical Associations)
- Member of the ISS Temporary Mission Structures:
+ Dementia: Prevention and care pathways, research, diagnosis and therapy
+ Health Inequalities
+ Undiagnosed sare diseases without a diagnosis
- Guest lecturer at the "International Seminars on Planetary Emergencies" of the Ettore Majorana Foundation and Centre for Scientific Culture
- Member of the National Ethics Committee for Health Protection in Correctional Facilities and Related Settings
- Member of the Steering Committee of the High Level Course on Medical Liability. Libera Università Maria SS. Assunta (LUMSA)
- Member of the Ethics Commission of the Consorzio Universitario per gli Studi Superiori e le Ricerche Applicate Studiorum
- Member of the ISS Task force on health inequalities
- Italian advisor in the European Union survey “Mapping European Research Ethics Committees – RECs & ethics review processes for biobank-based research”
- Since 2011: Member del Working Group on Ethical Issues of Alzheimer Europe
- 2009- 2010: Member of the International Advisory Board of the manual “Reviewing clinical trials: A guide for ethics committee” (Clinical Trials Centre, University of Hong Kong; Association for the Accreditation of Human Research Projects Protection Programs, Washington DC)
14) Auditions at the Chamber of Deputies and the Senate of the Italian Republic, as a representative of the Istituto Superiore di Sanità:
- Hearing in the debate on the draft laws "Rules on informed consent and declarations of intention anticipated in health treatments". Chamber of Deputies, Social Affairs Committee, 31 March 2016
- Hearing in the debate on the draft laws "Rules on informed consent and advance treatment provisions". Senate, Hygiene and Health Commission, 1 June 2017
- Hearing in the examination of the draft legislative decree containing amendments to the legislative decree 6 November 2007, n. 200, for the implementation of directive 2005/28/EC, adopted in implementation of the delegation for the reorganization and reform of the legislation on clinical trials for medicinal products for human use. Chamber of Deputies, Social Affairs Commission, 26 March 2019
- Hearing in the examination of the proposals of law n. 2, by popular initiative, C. 1586 Cecconi and C. 1655 Rostan, bearing "Rejection of medical treatment and lawfulness of euthanasia". Chamber of Deputies, Social Affairs and Justice Commissions, 4 June 2019
3. Other appointments
- Since 2002: Member of the Ethical Core of the project “Genome-wide analyses of European twin and population cohorts to identify genes predisposing to common diseases”
- Since 2001: Professor of Environmental Ethics and of Public Health Ethics, Faculty of Bioethics - Pontifical University Regina Apostolorum
- 2001-2002: Professor of bioethics, Faculty of Medicine - Catholic University of the Sacred Heart
- Since 1999 to 2013: Entrusted of the section “Ethics of the Biology” of the journal “Biologi Italiani”
- Chairman to thesis of degree and doctorate in bioethics
- Advisor on bioethical issues to various institutes, including:
+ Canadian Institutes of Health Research (Government of Canada) / Instituts de Recherche en Santé du Canada (Gouvernement du Canada)
+ Italian Data Protection Authority
+ Italian National Blood Centre
+ Italian National Transplant Centre
+ Italian Superior Council of Magistracy
+ European Science Foundation
+ Ministry of Health
• Member of the Editorial Board of:
- Annali dell'Istituto Superiore di Sanità (since 2020)
- Clinical Research and Regulatory Affairs (since 2013)
- International Journal of Clinical Therapeutics and Diagnosis (IJCTD) (since 2013)
- International Journal of Pharmaceutical Sciences and Clinical Pharmacy (since 2020)
- Journal of Clinical Research and Bioethics (since 2010)
- Journal of Personalized Medicine (since 2020)
- Medicina Historica (since 2021)
- Research International Journal of Clinical and Medical Case Reports (since 2020)
- Transplantology (since 2020)
- World Journal of Public Health (since 2020)
• Co-Editor of:
- Special Issue “Lessons Learned from Research on Rare Diseases: Ethical and Legal Challenges”. International Journal of Environmental Protection and Public Health
4. Research Projects
-Member of the Scientific Committee of the Project “Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response”. World Health Organization, WHO (since 1 December 2020).
-Project expert “I-Consent: Improving the guidelines for Informed Consent, including vulnerable populations, under a gender perspective” (2017-2019).
-Project expert “BBMRI: Biobanking and Biomolecular Resources Research Infrastructure” (since 2010).
-Head of the “Bioethics Unit” of the project “Revisione della nosografia degli stati vegetativi: applicazione di metodiche di analisi del comportamento a soggetti in coma e stato vegetativo”. Italian Ministry of Health (2008-2010).
-Head of the “Bioethics Unit” of the Program 1 of “Alleanza Contro il Cancro” of: “Riduzione delle disparità nell’accesso dei pazienti ai mezzi diagnostici e alle terapie”, workpackage 5: “Comunicazione e strutture informative in oncologia” (2008-2010).
-Head of the “Bioethics Unit” of the Rete Italiana BioBanche Oncologiche (RIBBO) of “Alleanza Contro il Cancro” (2008-2010).
Member of the Material Quality Assessment Committee (CVQ) of the Program Information Group 1 of “Alleanza Contro il Cancro” (2008-2010).
-Project Expert “EATRIS: The European Advanced Translational Research Infrastructure in Medicine” (since 2008).
-Member of Data and Safety Monitoring Board of the project “Studio multicentrico, randomizzato in doppio cieco sugli effetti dell’uso combinato di sali di litio e riluzolo nella sclerosi laterale amiotrofica (SLA)” (2009).
-Member of the Data and Safety Monitoring Board of the project “Antipsicotici e demenza di Alzheimer: una sperimentazione clinica multicentrica a lungo termine” (AdCare). Istituto Superiore di Sanità (2007-2010).
-Project Expert “Eurocan+Plus: Feasibility Study for Coordination of National Cancer Research Activities”. International Agency for Research on Cancer (2006-2007).
-Head of the Italian participation in “European Public Health Ethics Network”. European Commission (2003-2006).
-Member of the Ethics Core of the project “Genome-wide analyses of European twin and population cohorts to identify genes predisposing common diseases”. GenomEuTwin (2002-2006).
-Co-responsible for the project “Problematiche bioetiche legate alla sperimentazione con radiazioni”. Istituto Superiore di Sanità (2001-2004).
-Co-responsible for the project “Raccolta e diffusione dell’informazione nel campo della bioetica tramite un sistema elettronico integrato”. Istituto Superiore di Sanità (1999-2010).
-Collaboration in the project “EuEvidence: European Virtualized Infrastructure of Distributed ENvironments for Clustering E-science for medicine” (2010).
-Collaboration in the project “Ethicsweb: Inter-connected European information and documentation system for ethics and science: European Ethics Documentation Centre” (2008-2010).
-Collaboration in the project “Biometric Identification Technology Ethics”. Centro per la Scienza, la Società e la Cittadinanza (2004-2006).
- Since 2010: Italian Society for Safety and Quality in Transplant (SISQT)
- Since 2004: National Institute for the Study, the Evaluation and the Prevention of the Risk in the Technological Activities (INRPAT)
- Since 2000: Italian Society for Bioethics and the Ethics Committees (SIBCE)
- Since 2000: Association of Scientists and Technologists for the Ethics of the Development (STES)
- Since 1995: European Countries Biologists Association
- Since 1990: Directive of the “International Communication Society"
- Since 1990: Scientific committee of the journal “Innovazione, Comunicazione, Sviluppo”