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The Italian Prototype Networks of Research Biobanks

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Comparative Issues in the Governance of Research Biobanks

Abstract

Research-based biobanks will create new synergies between industry and public research structures, strengthening the competitiveness of our country for health industries. In addition to the ultimate objective of prevention and treatment of complex diseases, the short-term benefit will come from the development of new and more powerful diagnostic agents. In fact, molecular diagnostics, a new discipline based on “-omics” technologies, a powerful tool to understand diseases and assist individuals at risk, is one of the fastest growing segments in the healthcare industry. In order to collect the socio-economic benefits summarised above, many European countries, have underway, or are planning, large, well organised biobanks. However, the existing samples collection, resources, technologies and expertise have been developed under different ethical and legal landscapes across Europe. The existing collections suffer from fragmentation, variable access rules and the lack of commonly applied standards. This lack of standardization prevents the effective use of biological samples and data from different biobanks, which is a prerequisite to achieve sufficient statistical power for genomics research in humans. By initiating the Biobanking and Biomolecular Research Infrastructure (BBMRI) [All Member States and the Commission agreed on a shared vision of how the European Research Area (ERA) should develop by 2020 (http://ec.europa.eu/research/era/index_en.htm). This vision was adopted by the Council of Ministers in December 2008, and implemented for the needed infrastructures by ESFRI, the European Strategy Forum on Research Infrastructures, a already existing strategic instrument with the task of developing the scientific integration of Europe and to strengthen its international outreach. Since it was formed in 2002, at the behest of the European Council, ESFRI has witnessed significant advances towards unity and international impact in the field of research infrastructures. The publication of the first Roadmap for pan-European research infrastructures in 2006, and its update in 2008 (http://ec.europa.eu/research/infrastructures/index_en.cfm?pg=esfri) was a key contributing factor, and several projects are now in the realization phase like BBMRI (http://www.bbmri.eu/). BBMRI is a large scale project building a research infrastructure structured as a federated network of biological resources centres including all types of biobanks: disease oriented, population-based biobanks, biomolecular-resources; it includes all fields of medical research: rare diseases, cancer, complex diseases, etc.] on February 1st, 2008, Europe addressed the need to: harmonise standards for sample collection, storage and analysis; harmonise data collection and database infrastructure; provide ethical and legal guidance; develop a sustainable funding model for biobanks. This article describes some of the aspects of this European infrastructure.

Giuliano D’Agnolo is Vice-president of the National Committee on Biosafety, Biotechnology and Life Sciences, Presidenza del Consiglio dei Ministri; member of Alliance against cancer and the Istituto superiore di sanità with the task to liaise Italian research with the European infrastructures for life sciences (http://www.istge.it/fp_acc/index_file/Page672.htm).

Elena Bravo is Researcher of the Istituto superiore di sanità and Coordinator of the National Node of the Biobanking and Biomolecular Research Infrastructure (http://www.bmmri-eric.it).

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Notes

  1. 1.

    All Member States and the Commission agreed on a shared vision of how the European Research Area (ERA) should develop by 2020 (http://ec.europa.eu/research/era/index_en.htm). This vision was adopted by the Council of Ministers in December 2008, and implemented for the needed infrastructures by ESFRI, the European Strategy Forum on Research Infrastructures, an already existing strategic instrument with the task of developing the scientific integration of Europe and to strengthen its international outreach. Since it was formed in 2002, at the behest of the European Council, ESFRI has witnessed significant advances towards unity and international impact in the field of research infrastructures. The publication of the first Roadmap for pan-European research infrastructures in 2006, and its update in 2008 (http://ec.europa.eu/research/infrastructures/index_en.cfm?pg=esfri) was a key contributing factor, and several projects are now in the realisation phase like BBMRI (http://www.bbmri.eu/). BBMRI is a large scale project building a research infrastructure structured as a federated network of biological resources centres including all types of biobanks: disease oriented, population-based biobanks, biomolecular-resources; it includes all fields of medical research: rare diseases, cancer, complex diseases etc.

  2. 2.

    Council Regulation (EC) No 723/2009 of 25 June 2009 provided a common legal framework for a European Research Infrastructure Consortium (ERIC). ERIC is a legal entity with legal personality and full legal capacity recognised in all EU Member States. Its basic internal structure is very flexible leaving the members to define the statutes, case by case, membership rights and obligations, the bodies of the ERIC and their competence.

  3. 3.

    See http://www.bbmri.eu/index.php/national-hubs.

  4. 4.

    Alleanza Contro il Cancro (http://www.alleanzacontroilcancro.it/) associates the Italian comprehensive cancer centres in order to harmonise research on cancer, within Italy, and with the European programmes, by creating an exchange of information and cooperation among the leading European cancer institutes in order to create a European alliance on cancer. Alleanza Contro il Cancro has established a network of its biological repositories (http://www.iss.it/ribo/index.php?lang=2).

  5. 5.

    Garante per la protezione dei dati personali (2007).

  6. 6.

    The CNB and the CNBBSV, which are advisory bodies to the Prime Minister Office, have published jointly the “Guidelines for the collection of biological samples for research: informed consent” (http://www.governo.it/biotecnologie/documenti.html).

  7. 7.

    National Bioethics Committee (2006).

  8. 8.

    National Committee for Biosafety, Biotechnology and Life Sciences (2007).

  9. 9.

    Telethon Genetic Biobanks Network (http://www.biobanknetwork.org).

  10. 10.

    VAS (http://www.vas-int.org/sito/home.php?arg=1).

  11. 11.

    IRCCS are 42 research oriented hospitals supervised and financed by the Ministry of Health.

  12. 12.

    Centro per le risorse biologiche dell’Istituto Nazionale per la Ricerca sul Cancro di Genova (http://www.istge.it/crb/english.htm).

  13. 13.

    European Collection for Biomedical Research (ECBR) (http://ml570.istge.it/ecbr/ecbrsite.html).

  14. 14.

    ICLC is a core facility of IST, directed by Barbara Parodi. It offers a service of storage, quality control and distribution worldwide of certified human and animal cell lines, mainly of tumour origin. It belongs to the European network of Biological Resource Centres (BRCs) CABRI, and it has the role of International Deposit Authority (IDA) for patent purposes (http://www.iclc.it).

  15. 15.

    http://www.cnrb.it.

  16. 16.

    http://www.biorep.it.

  17. 17.

    Rebulla et al. (2008).

  18. 18.

    Menotti et al. (1989).

  19. 19.

    Urbinati et al. (2010).

  20. 20.

    http://www.ktl.fi/morgam/.

  21. 21.

    http://www.genomeeutwin.org. Quintana Trias (2003).

  22. 22.

    http://www.geha.unibo.it.

  23. 23.

    Capri et al. (2006).

  24. 24.

    http://www.moli-sani.org.

  25. 25.

    Donati (2010).

  26. 26.

    Personal communication (http://www.bbmri.eu/index.php/workpackages/wp-7).

  27. 27.

    Accordo tra il Governo, le Regioni e le Province autonome di Trento e Bolzano sulle linee progettuali per l’utilizzo da parte delle Regioni delle risorse vincolate, ai sensi dell’articolo 1, commi 34 e 34bis, della legge 23 dicembre 1996, n. 662, per la realizzazione degli obiettivi di carattere prioritario e di rilievo nazionale per l’anno 2009. Accordo ai sensi dell’articolo 1, comma 34bis, della legge 23 dicembre 1996, n. 662. http://www.statoregioni.it/testo_print.asp?idprov=6801&iddoc=21445&tipoDoc=2. Other biobank activities of mutual interest between the National Government and The Regional Authorities are described in http://www.ccm-network.it/.

  28. 28.

    http://www.tissuebank.it.

  29. 29.

    http://www.fiorgen.net.

  30. 30.

    http://www.cerm.unifi.it/home.

  31. 31.

    https://www.davincieuropeanbiobank.org.

  32. 32.

    Deliberazione delle giunta regionale n. 34 del 22 gennaio 2010. Riconoscimento delle Biobanche per diagnosi ricerca in Regione Liguria. Bollettino Ufficiale della Regione Liguria Anno XLI, n. 7 del 17 febbraio 2010.

  33. 33.

    http://www.ggb.galliera.it.

  34. 34.

    http://www.gaslini.org/.

  35. 35.

    http://www.arsliguria.it/index.php?option=com_content&task=view&id=2734&Itemid=221.

  36. 36.

    http://www.ccm-network.it/.

  37. 37.

    http://www.eurac.edu/en/research/institutes/geneticmedicine/default.html.

  38. 38.

    BBMRI News 24 July 2009 Issue 2.

  39. 39.

    http://www.bbmri-prototype.eu/.

  40. 40.

    The Rete Italiana delle Biobanche Oncologiche (RIBBO) is the natural evolution of the already mentioned initiative undertaken by Alleanza Contro il Cancro (http://www.iss.it/ribo/).

  41. 41.

    Official Journal of the Italian Republic. Bando per la selezione di progetti finalizzati alla realizzazione di un programma pilota per la gestione in rete delle biobanche e dei Centri di Risorse Biologiche (CRB-Net). G.U. 5a serie speciale n. 93 del 11 agosto 2008.

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D’Agnolo, G., Bravo, E. (2013). The Italian Prototype Networks of Research Biobanks. In: Pascuzzi, G., Izzo, U., Macilotti, M. (eds) Comparative Issues in the Governance of Research Biobanks. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-33116-9_18

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