Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts

Biopreservation and Biobanking

Volumn 14, Issue 3, 2016, Pages 201-206

  Kaye, Jane ^a   Briceño Moraia, Linda ^a   Mitchell, Colin ^a   Bell, Jessica ^a   Bovenberg, Jasper Adriaan ^b   Tassé, Anne Marie ^c   Knoppers, Bartha Maria ^c,d  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b Legal Pathways Institute for Health and Bio Law   (Netherlands)

^c Public Population Project in Genomics and Society (P3G)   (Canada)

^d MCGILL UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOBANK; COHORT ANALYSIS; COMMERCIAL PHENOMENA; EUROPEAN UNION; FINLAND; GERMANY; HEALTH CARE FACILITY; HUMAN; NETHERLANDS; NORWAY; ORGANIZATION AND MANAGEMENT; POLICY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RESEARCH ETHICS; SCIENTIST; STANDARDIZATION; UNITED KINGDOM; COOPERATION; FACTUAL DATABASE; INFORMATION DISSEMINATION; LEGISLATION AND JURISPRUDENCE; MEDICAL RESEARCH; PUBLIC RELATIONS;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; COOPERATIVE BEHAVIOR; DATABASES, FACTUAL; EUROPEAN UNION; FINLAND; GERMANY; HUMANS; INFORMATION DISSEMINATION; INTERPROFESSIONAL RELATIONS; NETHERLANDS; NORWAY; UNITED KINGDOM;

EID: 84973321077     PISSN: 19475535     EISSN: 19475543     Source Type: Journal    
DOI: 10.1089/bio.2015.0124     Document Type: Article

References (32)

1. Parodi B. Biobanks: A definition. In: Mascalzoni D (ed.). Ethics, Law and Governance of Biobanking. National, European and International Approaches. New York: Springer; 2015; p. 16.
2. Gottweis H, Zatloukal K. Biobank governance: Trends and perspectives. Pathobiology 2007;74:206-211.
3. Rial-Sebbag E, Cambon Thomsen A. Governing biobanks through a European infrastructure. In: D. Mascalzoni (ed.). Ethics, Law and Governance of Biobanking. National, European and International Approaches. Springer; 2015: 149.
4. Walport M, Brest P. Sharing research data to improve public health. Lancet 2011;377:537-539.
5. Biobank Standardisation and Harmonisation for Research Excellence in the European Union; BioSHaRE-EU is a consortium of leading biobanks and international researchers from all domains of biobanking science. Available from www.BioSHaRE.eu
6. Gottweis H, Kaye J, Bignami F, et al. Biobanks for Europe; A Challenge for Governance. Luxembourg: European Commission; 2012.
7. OECD. OECD Principles and Guidelines for Access to Research Data from Public Funding. OECD: Paris; 2007. Available from www.oecd.org/science/sci-tech/38500813.pdf Accessed May 9, 2016.
8. Powledge TM. Revisiting Bermuda. Genome Biol 2003;4; DOI:10.1186/gb-spotlight-20030311-01
9. The Wellcome Trust. Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility-Report of a meeting organized by the Wellcome Trust and held on 14-15 January 2003 at Fort Lauderdale, USA. Available from www.genome.gov/ Pages/Research/WellcomeReport0303.pdf
10. Toronto International Data Release Workshop et al. Prepublication data sharing. Nature 2009;461:168-170.
11. Knoppers BM. Framework for responsible sharing of genomic and health-related data. HUGO J 2014;8:3.
12. Nuffield Council on Bioethics. The Collection, Linking and Use of Data in Health Care and Biomedical Research: Ethical Issues. London: Nuffield Council on Bioethics; 2015. Available from http://nuffieldbioethics.org/wp-content/ uploads/Biological-and-health-data-web.pdf Accessed May 9, 2016.
13. Expert Advisory Group on Data Access. Governance of Data Access. London: The Wellcome Trust; 2015. Available from www.wellcome.ac.uk/stellent/groups/corporatesite/@ msh-peda/documents/web-document/wtp059343.pdf
14. OECD Guidelines on Human Biobanks and Genetic Research; 2009. Available from www.oecd.org/sti/biotech/ 44054609.pdf Accessed May 9, 2016.
15. HUGO Ethics Committee, Statement on Human Genomic Databases; 2002. Available from www.hugo-international. org/img/genomic-2002.pdf
16. Mascalzoni, et al. International Charter of principles for sharing bio-specimens and data. Eur J Hum Genet 2014; 23:721-728.
17. Knoppers BM, Chisholm RL, Kaye J, Cox D. A P3G generic access agreement for population genomic studies. Nature Biotech 2013;31:384-385.
18. Council Regulation (EC) No 723/2009 of 25 June 2009 on the Community legal framework for a European Research Infrastructure Consortium (ERIC).
19. Reichel J, Lind AS, Hansson MG, Litton JE. ERIC: A new governance tool for Biobanking. Eur J Hum Genet 2014; 22:1055-1057.
20. BRIF1640; National FINRISK Study 2007 (FINRISK); BBMRI-ERIC.
21. BRIF7781; Kooperative Gesundheitsforschung in der Region Augsburg (KORA).
22. BRIF4568; LifeLines Cohort Study & Biobank (LifeLines); BBMRI-ERIC.
23. BRIF2365; Nord-Trøndelag Health Study (HUNT); BBMRI-ERIC.
24. Elliot P, Peakman TC. The UK Biobank sample handling and storage protocol for the collection, processing and archiving of human blood and urine. Int J Epidemiol 2008; 37:234-244.
25. Mallette A, Tassé AM. P3G Model Framework for Biobank Access Policy: Core Elements (2013). Available from www.p3g.org/system/files/biobank-toolkit-documents/P3G %20Core%20Elements%20Access%20Policy%20Final%20 Dec%202013.pdf Accessed May 9, 2016.
26. NSD is a Limited Company owned by the Ministry of Education and Research. Available at www.nsd.uib.no/nsd/ english/index.html Accessed May 9, 2016.
27. UK Biobank. Access procedures: Application and review procedures for access to the UK Biobank Resource (V1.0 UK Biobank 2011). Available from www.ukbiobank.ac.uk/ wp-content/uploads/2012/09/Access-Procedures-2011.pdf
28. Kaye J. From single biobanks to international networks: Developing e-governance. Hum Genet 2011;130:377-382.
29. Briceno Moraia L, et al. A comparative analysis of the requirements for the use of data in Biobanks based in Finland, Germany, Netherlands, Norway and in the UK. Med Law Int 2014;4:187-212.
30. Reichel J. EU Governance for research and ethics in biobanks. In:Mascalzoni D (Ed.). Ethics, Law and Governance of Biobanking. National, European and International Approaches. New York: Springer; 2015; p. 175.
31. COUNCIL REGULATION (EC) No 723/2009 of 25 June 2009, Art. 12.
32. Commission Implementing Decision of 22 November 2013 on setting up the Biobanks and Biomolecular Resources Research Infrastructure Consortium (BBMRI-ERIC) as a European Research Infrastructure Consortium (2013/701/ EU); Article 15.