Italy is dramatically at the forefront of the COVID pandemic. It is a priority to structure a coordinated and extensive biobanking action, so that in the coming months there will be a global research opportunity to give a concrete health response to all citizens, with a model of collection, preparation, storage and distribution of samples/data that refers to a shared model and at the same time may become a reference model.
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It is indeed crucial to biobank the biological materials of the population concerned according to the established international criteria and in compliance both with ELSI (ethical-legal-social) requirements and the rights of the patients involved, in order to make them available over time for collaborative research projects. All this is key to developing the scientific knowledge needed to produce new systems of accurate and rapid diagnosis, vaccines and effective antiviral drugs, so that in the coming months the health response for all will be timely.
Both the quality and ethicality of the whole biobanking process and of the subsequent research are in fact determined by
- the informed consent of the person to whom those samples belong,
- the responsible custody that a service infrastructure such as the biobank is required to provide,
- the responsible and quality use by researchers of biological materials in research projects
The biobank, as an entity recognized by the competent authorities, must ensure and manage, according to proven quality standards and in a stable and continuous manner, the collection, preparation, storage and distribution of samples and related information for future research and/or diagnosis. Thus, the biobank performs a public and third-party function guaranteeing the biobanking process to all stakeholders: the sharing of biobanked samples as well as the research results, thanks to transparent access policies, is the cornerstone of the entire activity of a research biobank.
A COVID biobanking supported by an effective public information campaign, by a simplified and shared model of informed consent, and by the network of the biobanks, distributed throughout the country, represents a great opportunity for research and scientific citizenship for our country. Biobanking of COVID samples would become a recognized common heritage, to which to contribute with awareness, responsibility and solidarity, transforming the suffering of these days into a resource for all.
In Evidence
- Priority of an informed, coordinated and secure collection of samples/data from citizens infected and cured by COVID
- Opportunities to structure a national COVID biobank in quality, with the support and through the biobanks recognized by the institute in which they operate (institutional)
- Need to provide structured and transparent access (through unique codes and a common directory) to samples/data Directory comune
- Positivity of an extended participatory science action that makes everyone feel an active part of the recovery and research process
INFORMATION PROCESS
Process for Biobanking and COVID research
INFORMED CONSENT & ELSI TOOLS
INFORMED CONSENT & ELSI tools, for a dynamic, tailored and circumstantial informed consent
REGULATORY - ETHICAL FRAMEWORK
Ethics raccomandation about COVID research
ELSI BBMRI.it COVID-19 group
Coordinators: Sara Casati e Matteo Macilotti
Antonella Ficorilli | Biobanca del CReSM, San Luigi di Orbassano |
Franca Anglani | Università e AO di Padova |
Sara Bonomo | Università di Milano-Bicocca – BBMRI.it |
Elena Bravo | ISS – CORI – BBMRI.it |
Lorena Casareto | Istituto Ortopedico Rizzoli – Coordinamento Telethon Network of Genetic Biobanks |
Sara Casati | BBMRI.it, Common Service ELSI BBMRI.it |
Laura Conti | IRCCS Istituto Nazionale Tumori Regina Elena BBIRE-LB |
Domenico Coviello | IRCCS Istituto Giannina Gaslini |
Roberta Dameno | Università di Milano-Bicocca |
Simona Di Martino | IRCCS Istituto Nazionale Tumori Regina Elena BBIRE-LB |
Benedetta Donati | IRCCS Istituto Neurologico Mediterraneo Neuromed – Biobanca Molisani |
Maria Cristina Errico | ISS – CORI – BBMRI.it |
Marina Ferri | Azienda Provinciale per i Servizi Sanitari di Trento |
Tiziana Franchin | IRCCS Ospedale Pediatrico, Biobanca |
Francesca Fusco | Istituto di Genetica e Biofisica IGB, IPGB Biobank – CNR Napoli |
Sabina Gainotti | ISS – Unità di Bioetica |
Emanuela Giarin | AO di Padova – Biobanca Oncologica Pediatrica |
Matteo Gnocchi | CNR-ITB – BBMRI.it, Common Service IT BBMRI.it |
Tommasina Iorno | UNIAMO F.I.M.R., Fondazione Giambrone |
Enrica Lavezzini | Agenzia Sanitaria e Sociale Regione Emilia-Romagna |
Marialuisa Lavitrano | Università di Milano-Bicocca – BBMRI.it, Common Service ELSI BBMRI.it |
Manuela Locatelli | Istituto Ortopedico Rizzoli – S.C. Malattie Rare Scheletriche e BIOGEN |
Esther Longo | Università Cattolica del Sacro Cuore, Bioetica e Medical Humnanities |
Matteo Macilotti | Università di Trento, BBMRI.it, Common Service ELSI BBMRI.it |
Chiara Mandoj | IRCCS Istituto Nazionale Tumori Regina Elena BBIRE-LB |
Giordana Marcon | Università di Firenze – DaVinciBiobank |
Fabiana Marnetto | Biobanca del CReSM, San Luigi di Orbassano |
Lorenzo Merignati | Università di Milano-Bicocca, BBMRI.it |
Luciano Milanesi | CNR-ITB – BBMRI.it, Common Service IT BBMRI.it |
Laura Milita | CNR-ITB |
Luisa Minghetti | ISS – CORI – BBMRI.it |
Peppino Mirabelli | IRCCS SDN, Napoli – Biobanca |
Isabella Mori | Cittadinanza Attiva |
Marco Moscatelli | CNR-ITB – BBMRI.it, Common Service IT BBMRI.it |
Gaetana Paesano | Comitato Etico dell’Università Vanvitelli e dell’Azienda dei Colli di Napoli |
Barbara Parodi | IRCCS Ospedale Policlinico S. Martino – BBMRI.it, Common Service Qualità BBMRI.it |
Eva Pesaro | UNIAMO F.I.M.R., AISP |
Corinna Porteri | IRCCS Centro San Giovanni di Dio Fatebenefratelli |
Ilaria Riela | Fondazione IRCCS Istituto Neurologico “Carlo Besta” – Dipartimento Ricerca e Sviluppo Clinico |
Antonio Rimedio | Conferenza Regionale sperimentazioni cliniche – Regione Piemonte, Comitato Etico di Novara |
Annalisa Scopinaro | UNIAMO F.I.M.R. |
Gianni Tognoni | Ricerc@, IRCCS Istituto di Ricerche Farmacologiche “Mario Negri” |
Marta Tomasi | Università di Trento |
Matilde Valeria Ursini | CRB-IGB, CNR Napoli |
Silvia Veneroni | Fondazione IRCCS Istituto Nazionale dei Tumori Milano |
Giovanni Veronesi | Università dell’Insubria – EPIMED |
Paola Visconti | IRCCS Ospedale Policlinico S. Martino – BBMRI.it, Common Service Qualità BBMRI.it |