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Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research


Autoři: Melanie Goisauf aff001;  Gillian Martin aff001;  Heidi Beate Bentzen aff003;  Isabelle Budin-Ljøsne aff005;  Lars Ursin aff006;  Anna Durnová aff001;  Liis Leitsalu aff001;  Katharine Smith aff009;  Sara Casati aff010;  Marialuisa Lavitrano aff010;  Deborah Mascalzoni aff011;  Martin Boeckhout aff013;  Michaela Th. Mayrhofer aff001
Působiště autorů: BBMRI-ERIC, Graz, Austria aff001;  Department of Sociology, University of Malta, Msida, Malta aff002;  Norwegian Research Center for Computers and Law, Faculty of Law, University of Oslo, Oslo, Norway aff003;  Centre for Medical Ethics, Faculty of Medicine, University of Oslo, Oslo, Norway aff004;  Norwegian Institute of Public Health, Oslo, Norway aff005;  Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway aff006;  Institute for Advanced Studies, Vienna, Austria aff007;  Institute of Genomics, Estonian Genome Center, University of Tartu, Tartu, Estonia aff008;  Centre for Health Policy, Institute of Global Health Innovation, Imperial College London, London, England, United Kingdom aff009;  Department of Medicine and Surgery, University Milano—Bicocca, Milan, Italy aff010;  Department of Public Health, Center for Research Ethics and Bioethics, University of Uppsala CRB, Uppsala, Sweden aff011;  EURAC Research, Institute of Biomedicine, Bolzano, Italy aff012;  Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands aff013
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pone.0221496

Souhrn

Biobanks have evolved, and their governance procedures have undergone important transformations. Our paper examines this issue by focusing on the perspective of the professionals working in management or scientific roles in research-based biobanks, who have an important impact on shaping these transformations. In particular, it highlights that recent advances in molecular medicine and genomic research have raised a range of ethical, legal and societal implications (ELSI) related to biobank-based research, impacting directly on regulations and local practices of informed consent (IC), private-public partnerships (PPPs), and engagement of participants. In our study, we investigate the ways that these concerns influence biobanking practices and assess the level of satisfaction of the cross-national biobanking research communities with the ELSI related procedures that are currently in place. We conducted an online survey among biobankers and researchers to investigate secondary use of data, informing and/or re-contacting participants, sharing of data with third parties from industry, participant engagement, and collaboration with industrial partners. Findings highlight the need for a more inclusive and transparent biobanking practice where biobanks are seen in a more active role in providing information and communicating with participants; the need to improve the current IC procedures and the role of biobanks in sharing of samples and data with industry partners and different countries, and the need for practical, tangible and hands-on ethical and legal guidance.

Klíčová slova:

Biology and life sciences – Computational biology – Research and analysis methods – Social sciences – Computer and information sciences – Medicine and health sciences – Economics – Research design – Survey research – Surveys – Finance – Research facilities – Computer networks – Internet – Information technology – Data processing – Biological data management


Zdroje

1. Caenazzo L, Tozzo P. Biobanks and Public Health: A New Challenge for Public Engagement and Trust. Journal of Biomedical and Clinical Research. 2016;9(1):17–20.

2. Gottweis H, Gaskell G, Starkbaum J. Connecting the public with biobank research: reciprocity matters. Nature Reviews Genetics. 2011;12(11):738–9. doi: 10.1038/nrg3083 22005975

3. Liu A, Pollard K. Biobanking for personalized medicine. In: Karimi-Busheri F, editor. Biobanking in the 21st Century Advances in Experimental Medicine and Biology. Heidelberg, New York, Dordrecht, London: Springer, Cham; 2015. p. 55–68.

4. Spjuth O, Krestyaninova M, Hastings J, Shen H-Y, Heikkinen J, Waldenberger M, et al. Harmonising and linking biomedical and clinical data across disparate data archives to enable integrative cross-biobank research. Eur J Hum Genet. 2016;24(4):521–8. doi: 10.1038/ejhg.2015.165 26306643

5. Goisauf M, Durnová A. From Engaging Publics to Engaging Knowledges: Enacting “Appropriateness” in the Austrian Biobank Infrastructure. Public Underst Sci. 2018;28(3):275–89. doi: 10.1177/0963662518806451 30324869

6. Murad AM, Myers MF, Thompson SD, Fisher R, Antommaria AHM. A qualitative study of adolescents’ understanding of biobanks and their attitudes toward participation, re‐contact, and data sharing. American Journal of Medical Genetics Part A. 2017;173(4):930–7. doi: 10.1002/ajmg.a.38114 28328120

7. Cambon-Thomsen A. The social and ethical issues of post-genomic human biobanks. Nature Reviews Genetics. 2004;5:866–73. doi: 10.1038/nrg1473 15520796

8. Mayrhofer MT. About the New Significance and the Contingent Meaning of Biological Material and Data in Biobanks. History and Philosophy of the Life Sciences. 2013;35(3):449–67. 24779112

9. Harris JR, Burton P, Knoppers BM, Lindpaintner K, Bledsoe M, Brookes AJ, et al. Toward a roadmap in global biobanking for health. European Journal of Human Genetics. 2012;20(11):1105–11. doi: 10.1038/ejhg.2012.96 22713808

10. Mayrhofer MT, Prainsack B. Being a member of the club: The transnational self-governance of networks of biobanks. International Journal of Risk Assessment and Management 2009;12(1):64–81. doi: 10.1504/IJRAM.2009.024130

11. Lemke AA, Wolf WA, Hebert-Beirne J, Smith ME. Public and biobank participant attitudes toward genetic research participation and data sharing. Public Health Genomics. 2010;13(6):368–77. doi: 10.1159/000276767 20805700

12. Murphy J, Scott J, Kaufman D, Geller G, LeRoy L, Hudson K. Public perspectives on informed consent for biobanking. American Journal of Public Health. 2009;99(12):2128–34. doi: 10.2105/AJPH.2008.157099 19833988

13. D’Abramo F, Schildmann J, Vollmann J. Research participants’ perceptions and views on consent for biobank research: a review of empirical data and ethical analysis. BMC medical ethics. 2015;16(1):60. doi: 10.1186/s12910-015-0053-5 26354520

14. Thorogood A, Dalpé G, Knoppers BM. Return of individual genomic research results: are laws and policies keeping step? European Journal of Human Genetics. 2019:1. https://doi.org/10.1038/s41431-018-0311-3.

15. Bredenoord AL, Onland‐Moret NC, Van Delden JJ. Feedback of individual genetic results to research participants: in favor of a qualified disclosure policy. Human mutation. 2011;32(8):861–7. 10.1002/humu.21518 21538687

16. Lunshof JE, Church GM, Prainsack B. Raw Personal Data: Providing Access. Science. 2014;343(6169):373–4. 10.1126/science.1249382 24458627

17. Concannon TW, Fuster M, Saunders T, Patel K, Wong JB, Leslie LK, et al. A systematic review of stakeholder engagement in comparative effectiveness and patient-centered outcomes research. Journal of general internal medicine. 2014;29(12):1692–701. 10.1007/s11606-014-2878-x 24893581

18. Hofman P, Bréchot C, Zatloukal K, Dagher G, Clément B. Public–private relationships in biobanking: a still underestimated key component of open innovation. Virchows Archiv. 2014;464(1):3–9. https://doi.org/10.1007/s00428-013-1524-z. 10.1007/s00428-013-1524-z 24337181

19. Hämäläinen I, Toernwall O, Simell B, Zatloukal K, Perola M, van Ommen G-JB. Role of Academic Biobanks in Public–Private Partnerships in the European Biobanking and BioMolecular Resources Research Infrastructure Community. Biopreservation and Biobanking. 2018;17(1). 10.1089/bio.2018.0024 30499696

20. Lipworth W, Forsyth R, Kerridge I. Tissue donation to biobanks: a review of sociological studies. Sociology of health & illness. 2011;33(5):792–811. 10.1111/j.1467-9566.2011.01342.x 21592141

21. Sanderson SC, Brothers KB, Mercaldo ND, Clayton EW, Antommaria AHM, Aufox SA, et al. Public attitudes toward consent and data sharing in biobank research: a large multi-site experimental survey in the US. The American Journal of Human Genetics. 2017;100(3):414–27. https://doi.org/10.1016/j.ajhg.2017.01.021. 10.1016/j.ajhg.2017.01.021 28190457

22. Critchley C, Nicol D, McWhirter R. Identifying public expectations of genetic biobanks. Public Underst Sci. 2016;26(6):1–17. 10.1177/0963662515623925 26769748

23. McCormack P, Kole A, Gainotti S, Mascalzoni D, Molster C, Lochmü H, et al. ‘You should at least ask’. The expectations, hopes and fears of rare disease patients on large-scale data and biomaterial sharing for genomics research. European Journal of Human Genetics. 2016;24:1403–8. 10.1038/ejhg.2016.30 27049302

24. Hoeyer K. The power of ethics: a case study from Sweden on the social life of moral concerns in policy processes. Sociology of Health & Illness. 2006;28(6):785–801. 10.1111/j.1467-9566.2006.00542.x 17184418

25. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), (2016).

26. Mayrhofer MT, Holub P, Wutte A, Litton J-E. BBMRI-ERIC: the novel gateway to biobanks. Bundesgesundheitsblatt—Gesundheitsforschung—Gesundheitsschutz. 2016;59(3):379–84. 10.1007/s00103-015-2301-8 26860601

27. Mayrhofer MT, Schlünder I. Mind the Gap: From Tool to Knowledge Base. Biopreservation and Biobanking. 2018;16(6):458–62. 10.1089/bio.2018.0018 30102551

28. Burton PR, Banner N, Elliot MJ, Knoppers BM, Banks J. Policies and strategies to facilitate secondary use of research data in the health sciences. International Journal of Epidemiology. 2017;46(6):1729–33. 10.1093/ije/dyx195 29025140

29. Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K. Dynamic consent: a patient interface for twenty-first century research networks. European Journal of Human Genetics. 2015;23:141–6. 10.1038/ejhg.2014.71 24801761

30. Joly Y, Dalpé G, So D, Birko S. Fair Shares and Sharing Fairly: A Survey of Public Views on Open Science, Informed Consent and Participatory Research in Biobanking. PLoS ONE. 2015;10(7). https://doi.org/10.1371/journal.pone.0129893.

31. Petersen I, Desmedt C, Harris A, Buffa F, Kollek R. Informed consent, biobank research, and locality: perceptions of breast cancer patients in three European countries. Journal of Empirical Research on Human Research Ethics. 2014;9(3):48–55. 10.1177/1556264614540600 25746784

32. Explanatory Report–CETS 195 –to the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, (2005).

33. Budin-Ljøsne I, Mascalzoni D, Soini S, Machado H, Kaye J, Bentzen HB, et al. Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe? Biopreservation and Biobanking. 2016;14(3):241–8. 10.1089/bio.2015.0115 27082461

34. Ormond KE, Smith ME, Wolf WA. The Views of Participants in DNA Biobanks. Stanford Journal of Law, Science & Policy. 2010;1:80–7.

35. Mester JL, Mercer M, Goldenberg A, Moore RA, Eng C, Sharp RR. Communicating with Biobank Participants: Preferences for Receiving and Providing Updates to Researchers. Cancer Epidemiology Biomarkers & Prevention. 2015;24(4):708–12. 10.1158/1055-9965.Epi-13-1375 25597748

36. Steinsbekk KS, Solberg B. Biobanks—When is Re-consent Necessary? Public Health Ethics. 2011;4(3):236–50. https://doi.org/10.1093/phe/phr031.

37. Hemminki E, Tupasela A, Jallinoja P, Aro AR, Snell K, Sihvo S. Finnish people's attitudes towards biomedical research and its sponsorship. Genomics, Society and Policy. 2009;5(2):67–79. https://doi.org/10.1186/1746-5354-5-2-67.

38. Master Z, Campo-Engelstein L, Caulfield T. Scientists’ perspectives on consent in the context of biobanking research. European Journal of Human Genetics. 2015;23:569–74. https://doi.org/10.1038/ejhg.2014.143. 10.1038/ejhg.2014.143 25074466

39. Caulfield T, Murdoch B. Genes, cells, and biobanks: Yes, there’s still a consent problem. PLoS Biol. 2017;15(7). https://doi.org/10.1371/journal.pbio.2002654.

40. Teare HJA, Hogg J, Kaye J, Luqmani R, Rush E, Turner A, et al. The RUDY study: using digital technologies to enable a research partnership. European Journal of Human Genetics. 2017;25:816–22. 10.1038/ejhg.2017.57 28443622

41. Secko DM, Preto N, Niemayer S, Burgess M. Informed consent in biobank research: A deliberative approach to the debate. Soc Sci Med. 2009;68(4):781–9. https://doi.org/10.1016/j.socscimed.2008.11.020. 10.1016/j.socscimed.2008.11.020 19095337

42. Burgess MM. From ‘trust us’ to participatory governance: Deliberative publics and science policy. Public Underst Sci. 2014;23(1):48–52. https://doi.org/10.1177/0963662512472160. 10.1177/0963662512472160 24434712

43. Felt U, Fochler M. Machineries for Making Publics: Inscribing and De-scribing Publics in Public Engagement. Minerva. 2010;48(3):219–38. 10.1007/s11024-010-9155-x

44. Rensch S. EU public private partnerships not economically viable, say auditors. Public Finance International [Internet]. 2018 10.10.2018. Available from: https://www.publicfinanceinternational.org/news/2018/03/eu-public-private-partnerships-not-economically-viable-say-auditors.

45. Steinsbekk KS, Ursin LØ, Skolbekken J-A, Solberg B. We’re not in it for the money—lay people’s moral intuitions on commercial use of ‘their’biobank. Medicine, Health Care and Philosophy. 2013;16(2):151–62. 10.1007/s11019-011-9353-9 22028241

46. Caulfield T, Burningham S, Joly Y, Master Z, Shabani M, Borry P, et al. A review of the key issues associated with the commercialization of biobanks. Journal of Law and the Biosciences. 2014;1(1):94–110. https://doi.org/10.1093/jlb/lst004. 10.1093/jlb/lst004 27774156

47. Special Eurobarometer 460. Attitudes towards the impact of digitisation and automation on daily life. European Commission, 2017.

48. Ipsos MORI. The one-way mirror: public attitudes to commercial access to health data. Report prepared for the Wellcome Trust. 2016.

49. Aarden E. Projecting and producing ‘usefulness’ of biomedical research infrastructures; or why the Singapore Tissue Network closed. Science and Public Policy. 2017;44(6):753–62. 10.1093/scipol/scx010

50. Tierney WM, Meslin EM, Kroenke K. Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall? Journal of General Internal Medicine. 2016;31(2):228–33. 10.1007/s11606-015-3495-z 26307387

51. Meslin EM, Rager JB, Schwartz PH, Quaid KA, Gaffney MM, Duke J, et al. Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest. Clinical and Translational Medicine. 2015;4(1):36. 10.1186/s40169-015-0077-y 26668063


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