Biobanks for Europe - European Commission - Europa

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EUROPE DIRECT is a service to help you find answersto your questions about the European UnionFreephone number (*):00 800 6 7 8 9 10 11(*) Certain mobile telephone operators do not allow access to 00 800 numbers or these callsmay be billedLEGAL NOTICENeither the European Commission nor any person acting on behalf of the Commission is responsible for theuse which might be made of the following information.More information on the European Union is available on the Internet (http://europa.eu).Cataloguing data can be found at the end of this publication.Luxembourg: Publications Office of the European Union, 2012ISBN 978-92-79-22858-2doi:10.2777/68942© European Union, 2012Reproduction is authorised provided the source is acknowledged.Images © Fotolia, 2012
TABLE OF CONTENTSExecutive summary ...........................................................................................................................51• Introduction ......................................................................................................................................82• What is Governance? ................................................................................................................13• The Science of Biobanking ....................................................................................................123.1• What is a Biobank?...........................................................................................................133.2• Biobank designs ................................................................................................................143.2.1• Population-based biobanks ...............................................................................153.2.2• Disease-oriented biobanks ................................................................................153.2.3• Case-control biobanks .........................................................................................153.2.4• Tissue banks .............................................................................................................163.2.5• Biobanking within the context of clinical trials ......................................163.2.6• Other speci c biobanking formats: Guthrie cards, cord blood,stem cells .................................................................................................................................163.3• The potential of personalized medicine ...............................................................174• Biobanking in Europe ...............................................................................................................194.1• Prospects for harmonisation and networking in Europe ...............................194.2• Infrastructural and health care provision-related developmentsrelevant to biobanking .............................................................................................................214.3• Biobanking challenges in Europe .............................................................................215• Public Attitudes Towards Biobanking ...............................................................................235.1• A lack of public awareness ..........................................................................................245.2• Attitudes towards broad consent .............................................................................275.2.1• Protecting privacy as a key concern ..............................................................295.3• Trust ........................................................................................................................................315.4• Transparent Governance ...............................................................................................315.5• Patient Involvement ........................................................................................................326• The regulation of biobanks within Europe ................................................................... 346.1• Legal Instruments and Guidance .............................................................................356.1.1• The Council of Europe ...........................................................................................356.1.2• The European Union ..............................................................................................366.1.2.1• The Clinical Trials Directive .......................................................................366.1.2.2• The Data Protection Directive .................................................................37
Page 1 and 2: Biobanks forEuropeA Challenge for G
Page 3: EUROPEAN COMMISSIONBiobanks for Eur
Page 7 and 8: E 5Executive summaryThe member stat
Page 9 and 10: E 7Recommendation 4: Sustainable g
Page 11 and 12: I9frameworks and the principles for
Page 13 and 14: W G11The bene t of a relevant and
Page 15: T S B133.1• What is a Biobank?Bi
Page 18 and 19: 16T S BEpidemiological case-contro
Page 20 and 21: 18T S BThere are several important
Page 22 and 23: 20B EBiobank networking and harmon
Page 24 and 25: 22B Etia are increasing, there are
Page 26 and 27: 24P A T BThis section of the report
Page 28 and 29: 26P A T BFigure 2: Would you be wil
Page 30 and 31: 28P A T BFigure 3: Form of consent
Page 32 and 33: 30P A T BFigure 4: Levels of concer
Page 34 and 35: 32P A T Bto consider modes of inqui
Page 36 and 37: 34T E6• The regulation of bio
Page 38 and 39: 36T E6.1.2• The European Unio
Page 40 and 41: 38T EAccordingly, the above pro
Page 42 and 43: 40T EThe inconsistencies betwee
Page 44 and 45: 42T E• consent by the partici
Page 46 and 47: 44T E6.2.1• Research Ethics C
Page 48 and 49: 46C Gerty bene ts 132 ; and how to
Page 50 and 51: 48C GRecommendation 1Member states
Page 52 and 53: 50C G eld of biobanking, and in pa
Page 54 and 55:
52C Gawareness of the scienti c ne
Page 56 and 57:
54I B G8• Innovations in Biobank
Page 58 and 59:
56I B Gmore formal oversight bodie
Page 60 and 61:
58I B GCHRIS 179 projects for biob
Page 62 and 63:
60C R9• Conclusion andRecommenda
Page 64 and 65:
62A : S B EAnnex 1: Survey of Bi
Page 69:
European CommissionEUR 25302 — Bi
Page 72:
KI-NA-25-302-EN-CThis expert group
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Biobanks for Europe - European Commission - Europa

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