메뉴 건너뛰기




Volumn 14, Issue 4, 2014, Pages 187-212

A comparative analysis of the requirements for the use of data in biobanks based in Finland, Germany, the Netherlands, Norway and the United Kingdom

Author keywords

Access to data; Biobanks; Biomedical research; Cross border; Data protection

Indexed keywords

ARTICLE; BIOBANK; FINLAND; GERMANY; HEALTH PRACTITIONER; HUMAN; INFORMATION PROCESSING; LAW; MEDICAL INFORMATION; MEDICAL RESEARCH; NETHERLANDS; NORWAY; UNITED KINGDOM;

EID: 84937906357     PISSN: 09685332     EISSN: 20479441     Source Type: Journal    
DOI: 10.1177/0968533215571956     Document Type: Article
Times cited : (11)

References (64)
  • 2
    • 73449112365 scopus 로고    scopus 로고
    • Public access to genome-wide data: Five views on balancing research with privacy and protection
    • G. Church, C. Heeney, N. Hawkins, J. de Vries, P. Boddington, J. Kaye, M. Bobrow and B. Weir, 'Public Access to Genome-wide Data: Five Views on Balancing Research with Privacy and Protection', PLoS Genet 5(10) (2009), p. 1;
    • (2009) PLoS Genet , vol.5 , Issue.10 , pp. 1
    • Church, G.1    Heeney, C.2    Hawkins, N.3    De Vries, J.4    Boddington, P.5    Kaye, J.6    Bobrow, M.7    Weir, B.8
  • 3
    • 84937954352 scopus 로고    scopus 로고
    • Human rights, privacy and medical research: Analysing UK Policy on tissue and data
    • J. Gillot, 'Human rights, privacy and medical research: analysing UK Policy on tissue and data', Genetic Interest Group (2006). Available at: http://www.bionews.org.uk/page-37875.asp;
    • (2006) Genetic Interest Group
    • Gillot, J.1
  • 5
    • 80054767343 scopus 로고    scopus 로고
    • Data protection and sample management in biobanking-A legal dichotomy
    • T. Schulte in den Bäumen et al., 'Data Protection and Sample Management in Biobanking-A Legal Dichotomy', Genomics, Society and Policy 6 (2010), pp. 33-46.
    • (2010) Genomics, Society and Policy , vol.6 , pp. 33-46
    • Schulte, T.1
  • 6
    • 34247635153 scopus 로고    scopus 로고
    • Legal pathways for cross-border research: Building a legal platform for biomedical academia
    • J. Bovenberg, 'Legal Pathways for Cross-border Research: Building a Legal Platform for Biomedical Academia', European Journal of Human Genetics 15 (2007), pp. 522-524.
    • (2007) European Journal of Human Genetics , vol.15 , pp. 522-524
    • Bovenberg, J.1
  • 7
    • 84937935771 scopus 로고    scopus 로고
    • accessed 8 July 2014
    • Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:HTML (accessed 8 July 2014).
  • 10
    • 84937895938 scopus 로고    scopus 로고
    • accessed 8 April 2014
    • Available at: http://ec.europa.eu/justice/data-protection/article-29/index-en.htm (accessed 8 April 2014).
  • 11
    • 84937960291 scopus 로고    scopus 로고
    • To explore pan-European solutions for the cross-border data protection issues associated with BBMRI
    • See in general also J.-E. Litton and J. Bovenberg, 'To Explore Pan-European Solutions for the Cross-border Data Protection Issues Associated with BBMRI', BBMRI Joint Deliverable WP5 (2011);
    • (2011) BBMRI Joint Deliverable WP5
    • Litton, J.-E.1    Bovenberg, J.2
  • 12
    • 84937501332 scopus 로고    scopus 로고
    • The end of individual control over health information: Promoting fair information practices and governance of biobank research
    • J. Kaye and M. Stranger, eds. (Farnham: Ashgate)
    • T. Lemmens and L. Austin, 'The End of Individual Control over Health Information: Promoting Fair Information Practices and Governance of Biobank Research', in J. Kaye and M. Stranger, eds. Principles and Practice in Biobank Governance. (Farnham: Ashgate, 2009), p. 243.
    • (2009) Principles and Practice in Biobank Governance , pp. 243
    • Lemmens, T.1    Austin, L.2
  • 13
    • 84937899190 scopus 로고    scopus 로고
    • accessed 8 April
    • English translation is available at: http://www.finlex.fi/fi/laki/kaannokset/1999/en19990523.pdf (accessed 8 April 2014).
    • (2014)
  • 14
    • 34247588224 scopus 로고    scopus 로고
    • A legal framework for biobanking: The German experience
    • J. Simon et al, 'A Legal Framework for Biobanking: The German Experience', European Journal of Human Genetics 15 (2007), pp. 528-532.
    • (2007) European Journal of Human Genetics , vol.15 , pp. 528-532
    • Simon, J.1
  • 15
    • 84937905972 scopus 로고    scopus 로고
    • accessed 8 July 2014
    • Federal Data Protection Act (BDSG), in the version promulgated on 14 January 2003 (Federal Law Gazette I, p. 66), last amended by Article 1 of the Act of 14 August 2009 (Federal Law Gazette I, p. 2814), in force from 1 September 2009. An English version of the Act is available at: http://www.bfdi.bund.de/EN/DataProtectionActs/Artikel/BDSG-idFv01092009.pdf?-blob=publicationFile (accessed 8 July 2014).
  • 19
    • 0003692925 scopus 로고    scopus 로고
    • 16 July
    • Data Protection Act 1998, 16 July 1998, Available at: http://www.legislation.gov.uk/ukpga/1998/29/contents
    • (1998) Data Protection Act 1998
  • 20
    • 0004225782 scopus 로고    scopus 로고
    • (accessed 17 February 2000), (accessed 8 April 2014)
    • and The Data Protection (Processing of Sensitive Personal Data) Order 2000 (accessed 17 February 2000). Available at: http://www.legislation.gov.uk/uksi/2000/417/introduction/made (accessed 8 April 2014).
    • (2000) The Data Protection (Processing of Sensitive Personal Data) Order
  • 22
    • 84937869931 scopus 로고    scopus 로고
    • accessed 8 July 2014
    • The latest draft is available at: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2014-0212&language=EN&ring=A7-2013-0402 (accessed 8 July 2014).
  • 25
    • 84872413071 scopus 로고    scopus 로고
    • COM(2012)0011-C7-0025/2012-2012/0011(COD)). accessed 8 July 2014
    • Jan Philipp Albrecht; 'rapporteur' for the data protection dossier: DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council on the protection of individual with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) (COM(2012)0011-C7-0025/2012-2012/0011(COD)). Available at: http://www.europarl.europa.eu/meetdocs/2009-2014/documents/libe/pr/922/922387/922387en.pdf (accessed 8 July 2014).
    • General Data Protection Regulation
    • Jan, P.A.1
  • 27
    • 84880940838 scopus 로고    scopus 로고
    • Proposed EU data protection regulation is a threat to medical research
    • On the impact of the EU Regulation on biomedical research after Albrecht amendments, see M.C. Ploem, M.L. Essink-Bot, 'Proposed EU Data Protection Regulation is a Threat to Medical Research', British Medical Journal 364 (2013), f3534;
    • (2013) British Medical Journal , vol.364 , pp. 3534
    • Ploem, M.C.1    Essink-Bot, M.L.2
  • 29
    • 84898663838 scopus 로고    scopus 로고
    • Spies, data and research
    • L. Briceno Moraia and J. Kaye, 'Spies, Data and Research', EMBO Reports, 15(2) (2014), p. 123.
    • (2014) EMBO Reports , vol.15 , Issue.2 , pp. 123
    • Briceno Moraia, L.1    Kaye, J.2
  • 31
    • 84937908153 scopus 로고    scopus 로고
    • accessed 8 July 2014
    • See Article 9 of the Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (COM(2012)0011 Available at: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2F%2FEP%2F%2FTEXT%2BREPORT%2BA7-2013-0402%2B0%2BDOC%2BXML%2BV0%2F%2FEN&language=EN#title1. (accessed 8 July 2014).
  • 33
    • 84937896631 scopus 로고    scopus 로고
    • accessed 8 April 2014
    • 'Personal data' means any information relating to an identified or identifiable natural person ('data subject'); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, unique identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social or gender identity of that person, Available at: http://www.janalbrecht.eu/fileadmin/material/Dokumente/DPR-Regulation-inofficialconsolidated-LIBE.pdf (accessed 8 April 2014).
  • 35
    • 50849101381 scopus 로고    scopus 로고
    • Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays
    • accessed 24 October 2014
    • N. Homer and others, 'Resolving Individuals Contributing Trace Amounts of DNA to Highly Complex Mixtures using High-density SNP Genotyping Microarrays', PLoS Genet 4(8) (2008), p. e1000167. Available at: http://www.plosgenetics.org/article/info%3Adoi%2F10.1371%2Fjournal.pgen.1000167 (accessed 24 October 2014).
    • (2008) PLoS Genet , vol.4 , Issue.8 , pp. e1000167
    • Homer, N.1
  • 36
    • 84937823419 scopus 로고    scopus 로고
    • accessed 2 February 2012
    • 'Indeed, using a pseudonym means that it is possible to backtrack to the individual, so that the individual's identity can be discovered, but then only under predefined circumstances. In that case, although data protection rules apply, the risks at stake for the individuals with regard to the processing of such indirectly identifiable information will most often be low, so that the application of these rules will justifiably be more flexible than if information on directly identifiable individuals were processed' (Article 29 Working Party, Opinion 4/2007 on the concept of personal data, 20 June 2007, WP 136 2007). Available at: http://ec.europa.eu/justice/policies/privacy/docs/wpdocs/2007/wp136-en.pdf#page=15&zoom=auto,0,844 (accessed 2 February 2012).
  • 38
    • 50849101381 scopus 로고    scopus 로고
    • Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays
    • N. Homer, et al. 'Resolving Individuals Contributing Trace Amounts of DNA to Highly Complex Mixtures Using High-density SNP Genotyping Microarrays', PLoS Genetetics 4 (2008), p. e1000167;
    • (2008) PLoS Genetetics , vol.4 , pp. e1000167
    • Homer, N.1
  • 39
    • 51149088120 scopus 로고    scopus 로고
    • Genetic privacy. Whole-genome data not anonymous, challenging assumptions
    • J. Couzin, 'Genetic Privacy. Whole-genome Data not Anonymous, Challenging Assumptions', Science 321 (2008), p. 1278.
    • (2008) Science , vol.321 , pp. 1278
    • Couzin, J.1
  • 40
    • 84871136817 scopus 로고    scopus 로고
    • accessed 8 April 2014
    • Information Commissioner's Office (2012). Available at: http://www.ico.org.uk/for-organisations/data-protection/topic-guides/∗/media/documents/library/Data-Protection/Practical-application/anonymisation-code.ashx) (accessed 8 April 2014).
    • (2012) Information Commissioner's Office
  • 41
    • 84937942382 scopus 로고    scopus 로고
    • Anonymisation: Managing data protection risk-The new UK code
    • See also R. assey, 'Anonymisation: Managing Data Protection Risk-the New UK Code', Computer and Telecommunications Law Review 19 (2013), p. 86.
    • (2013) Computer and Telecommunications Law Review , vol.19 , pp. 86
    • Assey, R.1
  • 42
    • 84937909322 scopus 로고    scopus 로고
    • Anonymizing data for secondary use
    • accessed 2 february 2014
    • S. Lindsay and J. Goldring, 'Anonymizing Data for Secondary Use', Encyclopedia of Case Study Research 2010, Available at: http://srmo.sagepub.com/view/encyc-of-case-studyresearch/n10.xml (accessed 2 february 2014);
    • (2010) Encyclopedia of Case Study Research
    • Lindsay, S.1    Goldring, J.2
  • 43
    • 79955608859 scopus 로고    scopus 로고
    • Methods for de-identification of electronic health records for genomic research
    • K.E. Emam, Methods for De-identification of Electronic Health Records for Genomic Research', Genome Medicine 3 (2011), 25.
    • (2011) Genome Medicine , vol.3 , pp. 25
    • Emam, K.E.1
  • 44
    • 84937877104 scopus 로고    scopus 로고
    • accessed 8 April 2014
    • Codes of Conduct for medical research set out by the Dutch Council of the Federation of Medical Scientific Societies (Federatie Van Medisch Wetenschappelijke Verenigingen). Available at: http://www.federa.org/gedragscodes-codes-conduct-en (accessed 8 April 2014).
  • 45
    • 84937864832 scopus 로고    scopus 로고
    • accessed 8 July 2014
    • Available at: http://www.medlaw.nl/wp-content/uploads/commentsdutchrshgdprv22.pdf at 2 (accessed 8 July 2014).
  • 46
    • 84937955215 scopus 로고    scopus 로고
    • accessed 8 July 2014
    • Available at: http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy-communications/documents/web-document/wtvm054713.pdf (accessed 8 July 2014).
  • 47
    • 84937846268 scopus 로고    scopus 로고
    • accessed 8 April 2014, accessed 2 Februaty 2015
    • Under Amendment 23 of the so-called Albrecht amendments: [. ] This Regulation should not apply to anonymous data, meaning any data that cannot be related, directly or indirectly, alone or in combination with associated data, to a natural person or where establishing such a relation would require a disproportionate amount of time, expense, and effort, taking into account the state of the art in technology at the time of the processing and the possibilities for development during the period for which the data will be processed. (accessed 8 April 2014). Available at: http://www.janalbrecht.eu/fileadmin/material/Dokumente/DPR-Regulation-inofficial-consolidated-LIBE.pdf (accessed 2 Februaty 2015).
  • 49
    • 84930247205 scopus 로고    scopus 로고
    • Scientific and managerial premises and unresolved issues in tumor biobanking activities
    • G. Pascuzzi, U. Izzo and M. Macilotti, eds. (Berlin Heidelberg: Springer)
    • M. Barbareschi, S. Fasanella, C. Cantaloni and S. Giuliani, 'Scientific and Managerial Premises and Unresolved Issues in Tumor Biobanking Activities', in G. Pascuzzi, U. Izzo and M. Macilotti, eds. Comparative issues in the governance of research biobanks. (Berlin Heidelberg:Springer, 2013), pp. 301-309.;
    • (2013) Comparative Issues in the Governance of Research Biobanks , pp. 301-309
    • Barbareschi, M.1    Fasanella, S.2    Cantaloni, C.3    Giuliani, S.4
  • 50
    • 79951802866 scopus 로고    scopus 로고
    • Managing access to biobanks: How can we reconcile individual privacy and public interest in genetic research?
    • G. Laurie, P. Mallia, David A. Frenkel, A. Krajewska and H. Moniz, 'Managing Access to Biobanks: How Can We Reconcile Individual Privacy and Public Interest in Genetic Research?', Medical Law International 10(4) (2010), pp. 315-337.
    • (2010) Medical Law International , vol.10 , Issue.4 , pp. 315-337
    • Laurie, G.1    Mallia, P.2    David, A.F.3    Krajewska, A.4    Moniz, H.5
  • 51
    • 80053307605 scopus 로고    scopus 로고
    • From single biobanks to international networks: Developing e-governance
    • J. Kaye, 'From Single Biobanks to International Networks: Developing E-governance', Human Genetics 130 (2011), p. 377.
    • (2011) Human Genetics , vol.130 , pp. 377
    • Kaye, J.1
  • 56
    • 84937846459 scopus 로고    scopus 로고
    • accessed 2 February 2015
    • M. Taylor and B. Thompson, 'Update on the European Data Protection Regulation', Available at: http://www.p3g.org/sites/default/files/site/default/files/Taylor%20Thompson%20-%20Data%20Protection%20Regulation%20Update%2025%20February%202014%20V3.pdf (accessed 2 February 2015).
    • Update on the European Data Protection Regulation
    • Taylor, M.1    Thompson, B.2
  • 57
    • 84887916785 scopus 로고    scopus 로고
    • Data harmonization and federated analysis of population-based studies: The bioshare project
    • accessed 2 February 2015
    • D. Doiron et al., 'Data Harmonization and Federated Analysis of Population-based Studies: The BioSHaRE Project', Emerging Themes in Epidemiology 10 (2013), p. 12. Available at: http://www.webcitation.org/query.php?url=http://www.bioshare.eu&refdoi=10.1186/1472-6823-14-9 (accessed 2 February 2015).
    • (2013) Emerging Themes in Epidemiology , vol.10 , pp. 12
    • Doiron, D.1
  • 58
    • 78149243538 scopus 로고    scopus 로고
    • DataSHIELD: Resolving a conflict in contemporary bioscience-performing a pooled analysis of individual-level data without sharing the data
    • (Data aggregation through anonymous summary statistics from harmonized individual level databases), M. Wolfson et al., 'DataSHIELD: Resolving a Conflict in Contemporary Bioscience-Performing a Pooled Analysis of Individual-level Data Without Sharing the Data', International Journal of Epidemiology 39(5) (2010), pp. 1372-1382.
    • (2010) International Journal of Epidemiology , vol.39 , Issue.5 , pp. 1372-1382
    • Wolfson, M.1
  • 60
    • 84893193652 scopus 로고    scopus 로고
    • The prevalence of metabolic syndrome and metabolically healthy obesity in Europe: A collaborative analysis of ten large cohort studies
    • accessed 2 February 2015
    • J.V.van Vlier-Ostaptchouk et al., 'The Prevalence of Metabolic Syndrome and Metabolically Healthy Obesity in Europe: A Collaborative Analysis of Ten Large Cohort Studies', BMC Endocrine Disorders 14 (2014), p. 9. Available at: http://www.biomedcentral.com/1472-6823/14/9 (accessed 2 February 2015).
    • (2014) BMC Endocrine Disorders , vol.14 , pp. 9
    • Van Vlier-Ostaptchouk, J.V.1
  • 64
    • 31344467157 scopus 로고    scopus 로고
    • Do we need a uniform regulatory system for biobanks across Europe?
    • J. Kaye, 'Do We Need a Uniform Regulatory System for Biobanks Across Europe?', European Journal of Human Genetics 14(2) (2006), pp. 245-248.
    • (2006) European Journal of Human Genetics , vol.14 , Issue.2 , pp. 245-248
    • Kaye, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.