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12T S B3• The Science of BiobankingContemporary medicine is moving from “reactive approaches” centered on disease therapy topersonalized, predictive, preventive and participatory medicine (“P4 Medicine”) which focuseson the maintenance of health 8,9 . This transition is fostered by advances derived from sequencingof the human genome and rapid improvements in bioinformatics and analytical laboratorytechnologies 8,10 . Biobanks have the potential to become important tools and instruments for helpingto drive this change in healthcare delivery.Given the immense complexity of human biology, medical research has traditionally been utilizinga so called “reductionist strategy” 9,11 . This strategy, used in current medical research and practice,is based on the assumption that itemization of complex biological phenomena into smaller“research issues” makes them more easily amenable to our current technical possibilities and tohuman reason/logic-based examinations 7,10 . Although this research strategy has been very successful,it is now reaching its intangible limits. With few exceptions, it is becoming evident thatcomplex diseases cannot be ascribed to disturbances of individual biological entities, e.g. merelymutated genes 9,11,12 .In order to address the substantial complexities of biology and medicine, interdisciplinary eldsof systems biology/systems medicine have been established. In these young scienti c disciplinesinteractions of individual biological elements are studied by advanced mathematical and statisticsstrategies. Systems biology can not only retrospectively analyses biological parameters, but alsocan model in silico dierent interactions. Thus, systems biology research combines “wet laboratory”experimentation with “dry laboratory” predictions of biological processes, and vice versa. 8,9,10All these developments, which started to accelerate approximately a decade ago, have led to therapid establishment of organized biobanking 13,14 .8 Hood L, Rowen L, Galas DJ, Aitchison JD., Systems biology at the Institute for Systems Biology,Briefi ngs in Functional Genomics and Proteomics 2008 ,Vol. 7, pp.239-248.9 Loscalzo J, Barabasi AL., ´Systems biology and the future of medicine´, Wiley Interdisciplinary Review ofSystems Biology Medicine, 2011, Vol. 3, No. 6, pp.619-627.10 Ginsburg GS, Willard HF, Genomic and personalized medicine: foundations and applications.Translational Research, 2009, Vol.154, No. 6, pp. 277-287.11 Sobradillo P, Pozo F, Agustí A., P4 medicine: the future around the corner, Archivos de Bronconeumologia.2011, Vol. 47, No. 1, pp.35-40.12 Venter JC, Adams MD, Myers EW, Li PW, Mural RJ, Sutton GG, et al. The sequence of the humangenome, Science, 2001, Vol.291, pp. 1304-1351.13 Asslaber M, Zatloukal K., Biobanks: transnational, European and global networks, Briefi ngs inFunctional Genomics and Proteomics. 2007, Vol. 6, No. 3, p. 193-201.14 Riegman PH, Morente MM, Betsou F, de Blasio P, Geary P, Biobanking for better healthcare andthe Marble Arch International Working Group on Biobanking for Biomedical Research, MolecularOncology. 2008, Vol. 2, No. 3, pp.213-222.
T S B133.1• What is a Biobank?Biobanks typically: (a) collect and store biological materials that are annotated not only with medical,but oen also epidemiological data (e.g. environmental exposures, lifestyle/occupational information);(b) are not static “projects”, since biological materials and data are usually collected on a continuousor long-term basis; (c) are associated with current (de ned) and/or future (not yet speci ed) researchprojects at the time of biospecimen collection; (d) apply coding or anonymisation to assure donor privacybut have, under speci c conditions, provisions that participants remain re-identi able in order toprovide clinically relevant information back to the donor 13,14,15 ; and (e) include established governancestructures (e.g. ethics review committees) and procedures (e.g. consent) that serve to protect donors’rights and stakeholder interests 16 .Notwithstanding some shared features, the eld of biobanking is, generally speaking, very heterogeneous13,14,15 . Although it is di cult to exhaustively list all distinguishing characteristics of biobanks, thereare some that can be used to characterize dierent types of biobanks. These are size, research design,the types of biological samples collected, the method of sample collection, processing and storage, andthe disease/research focus. These characteristics will in uence the scope of biobank activities, such asthe recruitment of donors, the consent procedures, the scale of informatics support needed, the governancestructures, and the potential for commercial exploitation. Until recently, terminology denotingorganized collections in medicine has not been consistent. A number of terms such as “human geneticresearch databases (HGRDs)”, “population genetic databases”, “biorepositories”, or “tissue banks” havebeen used to refer to activities involving biobanks/biobanking. However, “biobank” is now the over-archingterm that is most commonly used. An example of a European legal de nition of a biobank is foundin the Council of Europe Recommendation on research on biological materials of human origin (2006) 17which also refers explicitly to biobanks (BOX 2). This could also be applied to other types of biobanks.B O X 2 Legal definition of a population biobank 17Article 171. A population biobank is a collection of biological materials that has the following characteristics:i. the collection has a population basis;ii. it is established, or has been converted, to supply biological materials or data derived therefrom formultiple future research projects;iii. it contains biological materials and associated personal data, which may include or be linked to genealogical,medical and lifestyle data and which may be regularly updated;iv. it receives and supplies materials in an organised manner.3. Member states should consider applying the provisions of this chapter to collections that have some, butnot all, of the characteristics specied in paragraph 1.15 http://www.austlii.edu.au/au/journals/JlLawInfoSci/2010/5.html16 Yuille M, Dixon K, Platt A, Pullum S, Lewis D, Hall A, Ollier W., The UK DNA banking network: a“fair access” biobank, Cell and Tissue Banking., 2010, Vol. 11, No. 3, pp. 241-251.17 https://wcd.coe.int/ViewDoc.jsp?id=977859 (This Recommendation is currently under re-examination)
Page 1 and 2: Biobanks forEuropeA Challenge for G
Page 3 and 4: EUROPEAN COMMISSIONBiobanks for Eur
Page 5 and 6: TABLE OF CONTENTSExecutive summary
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: W G11The bene t of a relevant and
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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