Big Data in medical research and EU data protection law: Challenges to the consent or anonymise approach

European Journal of Human Genetics

Volumn 24, Issue 7, 2016, Pages 956-960

  Mostert, Menno ^a   Bredenoord, Annelien L ^a   Biesaart, Monique C I H ^a   Van Delden, Johannes J M ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANONYMISED DATA; ARTICLE; CONCEPTUAL FRAMEWORK; DATA PROCESSING; HUMAN; INFORMED CONSENT; MEDICAL RECORD; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; PRIORITY JOURNAL; ANONYMIZATION; DATA BASE; EUROPEAN UNION; LEGISLATION AND JURISPRUDENCE;

BIOMEDICAL RESEARCH; DATA ANONYMIZATION; DATABASES AS TOPIC; EUROPEAN UNION; HUMANS;

EID: 84946762381     PISSN: 10184813     EISSN: 14765438     Source Type: Journal    
DOI: 10.1038/ejhg.2015.239     Document Type: Article

References (70)

1. Costa FF: Big Data in biomedicine. Drug Discov Today 2014; 19: 433-440.
2. Mooney SJ, Westreich DJ, El-Sayed AM: Epidemiology in the era of Big Data. Epidemiology 2015; 26: 390-394.
3. Hustinx P EU Data Protection Law: The Review of Directive 95/46/EC and the Proposed General Data Protection Regulation, 2014. Available at https: //secure. edps.europa.eu/EDPSWEB/webdav/site/mySite/shared/Documents/EDPS/Publications/ Speeches/2014/14-09-15-Article-EUI-EN.pdf.
4. Parliament's draft GDPR: European Parliament Legislative Resolution on the Proposal for a General Data Protection Regulation, 12 March 2014. Available at http: //www. europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2014-0212+0+ DOC+XML+V0//EN.
5. Council's draft GDPR: The General Approach of the Council of the EU on the General Data Protection Regulation, 15 June 2015. Available at http: //data.consilium.europa. eu/doc/document/ST-9565-2015-INIT/en/pdf.
6. Council of the EU: Data Protection: Council Agrees on a General Approach, 2015. Available at http: //www.consilium.europa.eu/en/press/press-releases/2015/06/15-jhadata- protection/.
7. Academy of Medical Sciences: Personal Data for Public Good: Using Health Information in Medical Research, 2006. Available at http: //www.acmedsci.ac.uk/download.php? f=file&i=13206.
8. Sethi N, Laurie G: Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together. Med Law Int 2013; 13: 168-204.
9. Ruyter KW, Louk K, Jorqui M, Kvalheim V, Cekanauskaite A, Townend D: From research exemption to research norm: Recognising an alternative to consent for large scale biobank research. Med Law Int 2010; 10: 287-313.
10. Ploem MC, Essink-Bot ML, Stronks K: Proposed EU data protection regulation is a threat to medical research. BMJ 2013; 346: F3534.
11. Di Lorio CT, Carinci F, Oderkirk J: Health research and systems' governance are at risk: Should the right to data protection override health? J Med Ethics 2014; 40: 488-492.
12. Kerr DJ: Policy: EU data protection regulation-harming cancer research. Nat Rev Clin Oncol 2014; 11: 563-564.
13. Dolgin E: New data protection rules could harm research, science groups say. Nat Med 2014; 20: 224.
14. Nyrén O, Stenbeck M, Grönberg H: The European Parliament proposal for the new EU General Data Protection Regulation may severely restrict European epidemiological research. Eur J Epidemiol 2014; 29: 227-230.
15. Dove ES, Townend D, Knoppers BM: Data protection and consent to biomedical research: A step forward? Lancet 2014; 384: 855.
16. Coppen R, van Veen EB, Groenewegen PP et al: Will the trilogue on the EU Data Protection Regulation recognise the importance of health research? Eur J Public Health 2015; 25: 757-758.
17. May M: Life Science Technologies: Big biological impacts from Big Data. Science 2014; 344: 1298-1300.
18. Wang W, Krishnan E: Big Data and clinicians: A review on the state of the science. JMIR Med Informatics 2014; 2: E1.
19. Jensen PB, Jensen LJ, Brunak S: Mining electronic health records: Towards better research applications and clinical care. Nat Rev Genet 2012; 13: 395-405.
20. Currie J: 'Big Data' versus 'big brother': On the appropriate use of large-scale data collections in pediatrics. Pediatrics 2013; 131: S127-S132.
21. Marx V: Biology: The big challenges of Big Data. Nature 2013; 498: 255-260.
22. Apple's ResearchKit frees medical research. Nat Biotechnol 2015; 33: 322.
23. Costa FF: Social networks, web-based tools and diseases: Implications for biomedical research. Drug Discov Today 2013; 18: 272-281.
24. Pereira S, Gibbs RA, McGuire AL: Open access data sharing in genomic research. Genes (Basel) 2014; 5: 739-747.
25. Weber GM, Mandl KD, Kohane IS: Finding the missing link for big biomedical data. JAMA 2014; 311: 2479-2480.
26. Allen NE, Sudlow C, Peakman T, Collins R: UK biobank data: Come and get it. Sci Transl Med 2014; 6: 224ed4.
27. Van Ommen G-JB, Törnwall O, Bréchot C et al: BBMRI-ERIC as a resource for pharmaceutical and life science industries: The development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23: 893-900.
28. Knoppers BM: International ethics harmonization and the global alliance for genomics and health. Genome Med 2014; 6: 13.
29. Gellert R, Gutwirth S: The legal construction of privacy and data protection. Comput Law Secur Rev 2013; 29: 522-530.
30. Hallinan D, Friedewald M, De Hert P: Genetic data and the data protection regulation: Anonymity, multiple subjects, sensitivity and a prohibitionary logic regarding genetic data? Comput Law Secur Rev 2013; 29: 317-329.
31. New challenges to data protection, Working Paper No. 2: Data protection laws in the EU. European Commission, 2010. Available at http: //ec.europa.eu/justice/policies/ privacy/docs/studies/new-privacy-challenges/final-report-working-paper-2-en.pdf.
32. Nuffield Council on Bioethics: The collection, linking and use of data in biomedical research and health care: Ethical issues, 2015. Available at http: //nuffieldbioethics.org/ wp-content/uploads/Biological-and-health-data-web.pdf.
33. Mittelstadt BD, Floridi L: The ethics of Big Data: Current and foreseeable issues in biomedical contexts. Sci Eng Ethics 2015; e-pub ahead of print 23 May 2015; doi: 10.1007/s11948-015-9652-2.
34. Boddington P, Curren L, Kaye J et al: Consent forms in genomics: The difference between law and practice. Eur J Health Law 2011; 18: 491-519.
35. McGuire AL, Beskow LM: Informed consent in genomics and genetic research. Annu Rev Genomics Hum Genet 2010; 11: 361-381.
36. Steinsbekk KS, Kare Myskja B, Solberg B: Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem? Eur J Hum Genet 2013; 21: 897-902.
37. Casali PG: Risks of the new EU Data protection regulation: An ESMO position paper endorsed by the European oncology community. Ann Oncol 2014; 25: 1458-1461.
38. Petrini C: 'Broad' consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Soc Sci Med 2010; 70: 217-220.
39. Laurie G, Postan E: Rhetoric or reality: What is the legal status of the consent form in health-related research? Med Law Rev 2013; 21: 371-414.
40. Master Z, Nelson E, Murdoch B, Caulfield T: Biobanks, consent and claims of consensus. Nat Methods 2012; 9: 885-888.
41. Kaye J: The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet 2012; 13: 415-431.
42. Allen J, McNamara B: Reconsidering the value of consent in biobank research. Bioethics 2011; 25: 155-166.
43. Caulfield T, Kaye J: Broad consent in biobanking: Reflections on seemingly insurmountable dilemmas. Med Law Int 2009; 10: 85-100.
44. Helgesson G: In defense of broad consent. Camb Q Healthc Ethics 2012; 21: 40-50.
45. Hallinan D, Friedewald M: Open consent, biobanking and data protection law: Can open consent be 'informed' under the forthcoming data protection regulation? Life Sci Soc Policy 2015; 11: 1.
46. Kaye J, Curren L, Anderson N et al: From patients to partners: Participant-centric initiatives in biomedical research. Nat Rev Genet 2012; 13: 371-376.
47. Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K: Dynamic consent: A patient interface for twenty-first century research networks. Eur J Hum Genet 2014; 23: 141-146.
48. Williams H, Spencer K, Sanders C et al: Dynamic consent: A possible solution to improve patient confidence and trust in how electronic patient records are used in medical research. JMIR Med Informatics 2015; 3: E3.
49. Heeney C, Hawkins N, de Vries J, Boddington P, Kaye J: Assessing the privacy risks of data sharing in genomics. Public Health Genomics 2011; 14: 17-25.
50. Mascalzoni D, Dove ES, Rubinstein Y et al: International Charter of principles for sharing bio-specimens and data. Eur J Hum Genet 2014; 23: 721-728.
51. McGuire AL, Caulfield T, Cho MK: Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet 2008; 9: 152-156.
52. Rodriguez LL, Brooks LD, Greenberg JH, Green ED: Research ethics. The complexities of genomic identifiability. Science 2013; 339: 275-276.
53. Gymrek M, McGuire AL, Golan D, Halperin E, Erlich Y: Identifying personal genomes by surname inference. Science 2013; 339: 321-324.
54. Article 29 Data Protection Working Party. Opinion 05/2014 on Anonymisation Techniques, 2014. Available at http: //ec.europa.eu/justice/data-protection/article-29/ documentation/opinion-recommendation/files/2014/wp216-en.pdf.
55. O'Brien SJ: Stewardship of human biospecimens, DNA, genotype, and clinical data in the GWAS era. Annu Rev Genomics Hum Genet 2009; 10: 193-209.
56. Knoppers BM, Zawati MH, Kirby ES: Sampling populations of humans across the world: ELSI issues. Annu Rev Genomics Hum Genet 2012; 13: 395-413.
57. Tene O, Polonetsky J: Privacy in the age of Big Data: A time for big decisions. Stanford Law Rev Online 2012; 64: 63-69.
58. Lowrance WW: Privacy, Confidentiality, and Health Research. Cambridge University Press: Cambridge, UK, 2012.
59. van Veen EB: Europe and tissue research: A regulatory patchwork. Diagn Histopathol 2013; 19: 331-336.
60. Ploem MC: Towards an appropriate privacy regime for medical data research. Eur J Health Law 2006; 13: 41-63.
61. Sethi N: The promotion of data sharing in pharmacoepidemiology. Eur J Health Law 2014; 21: 271-296.
62. Greely HT: The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annu Rev Genomics Hum Genet 2007; 8: 343-364.
63. Laurie G: Genetic privacy: A Challenge to Medico-Legal Norms. Oxford University Press: New York, 2002.
64. Gaye A, Marcon Y, Isaeva J et al: DataSHIELD: Taking the analysis to the data, not the data to the analysis. Int J Epidemiol 2014; 43: 1929-1944.
65. Wolfson M, Wallace SE, Masca N et al: DataSHIELD: Resolving a conflict in contemporary bioscience-performing a pooled analysis of individual-level data without sharing the data. Int J Epidemiol 2010; 39: 1372-1382.
66. Wallace SE, Gaye A, Shoush O, Burton PR: Protecting personal data in epidemiological research: DataSHIELD and UK Law. Public Health Genomics 2014; 17: 149-157.
67. Budin-Ljøsne I, Burton P, Isaeva J et al: DataSHIELD: An ethically robust solution to multiple-site individual-level data analysis. Public Health Genomics 2015; 18: 87-96.
68. Abbing HD: EU cross-border healthcare and health law. Eur J Health Law 2015; 22: 1-12.
69. Prainsack B, Buyx A: A solidarity-based approach to the governance of research biobanks. Med Law Rev 2013; 21: 71-91.
70. Kaye J: From single biobanks to international networks: Developing e-governance. Hum Genet 2011; 130: 377-382.