Big Data and Health Research—The Governance Challenges in a Mixed Data Economy

Journal of Bioethical Inquiry

Volumn 14, Issue 4, 2017, Pages 515-525

  Holm, Søren ^a   Ploug, Thomas ^b  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b AALBORG UNIVERSITY   (Denmark)

Author keywords

Big data; Biobanks; Data protection; Databases; Informed consent; Meta consent; Research use of health data

Indexed keywords

BIOBANK; COMMERCIAL PHENOMENA; CONFIDENTIALITY; DECISION MAKING; DENMARK; ETHICS; GENETICS; GOVERNMENT; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; LEGISLATION AND JURISPRUDENCE; MEDICAL INFORMATION SYSTEM; MEDICAL RESEARCH; PATIENT RIGHT; PRIVACY; PROFESSIONAL STANDARD; REGISTER; RESEARCH ETHICS; SOCIAL CONTROL;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; COMMERCE; CONFIDENTIALITY; DATASETS AS TOPIC; DECISION MAKING; DENMARK; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; GENETIC RESEARCH; GOVERNMENT; HEALTH INFORMATION MANAGEMENT; HUMANS; INFORMED CONSENT; PATIENT RIGHTS; PRIVACY; REGISTRIES; SOCIAL CONTROL, FORMAL;

EID: 85030544791     PISSN: 11767529     EISSN: 18724353     Source Type: Journal    
DOI: 10.1007/s11673-017-9810-0     Document Type: Conference Paper

References (34)

1. Bakos, Y., F. Marotta-Wurgler, and D.R. Trossen. 2009. Does anyone read the fine print? Testing a law and economics approach to standard form contracts. CELS 2009 4th annual conference on empirical legal studies paper. NYU Law and Economics Research Paper No. 09-40.
2. Bjørn-Hansen, S. 2016. Eksperter om CPR-læk: Amatøragtig omgang med data [Experts on CPR-leak: Amateurish handling of data]. https://www.dr.dk/nyheder/viden/tech/eksperter-om-cpr-laek-amatoeragtig-omgang-med-data. Accessed June 24, 2017.
3. Cambon-Thomsen, A. 2004. The social and ethical issues of post-genomic human biobanks. Nature Review Genetics 5(11): 866–873.
4. Daugbjerg, S.B., G. Cesaroni, B. Ottesen, F. Diderichsen, and M. Osler. 2014. Effect of socioeconomic position on patient outcome after hysterectomy. Acta obstetricia et gynecologica Scandinavica 93(9): 926–934.
5. European Commission. 2015. Standard Eurobarometer 83: Public opinion in the European Union. Spring. http://ec.europa.eu/public_opinion/archives/eb/eb83/eb83_publ_en.pdf.
6. Faden, R.R., N.E. Kass, S.N. Goodman, P. Pronovost, S. Tunis, and T.L. Beauchamp. 2013 An ethics framework for a learning health care system: A departure from traditional research ethics and clinical ethics. Hastings Center Report 43(s1): S16–S27.
7. Frisch, M., and J. Simonsen. 2015. Ritual circumcision and risk of autism spectrum disorder in 0- to 9-year-old boys: National cohort study in Denmark. Journal of the Royal Society of Medicine 108(7): 266–279.
8. Hansson, M.G., J. Dillner, C.R. Bartram, J.A. Carlson, G. Helgesson. 2006. Should donors be allowed to give broad consent to future biobank research? Lancet Oncology 7(3): 266–269.
9. Havelin, L.I., O. Robertsson, A.M. Fenstad, S. Overgaard, G. Garellick, and O. Furnes. 2011. A Scandinavian experience of register collaboration: The Nordic Arthroplasty Register Association (NARA). The Journal Of Bone and Joint Surgery 93(Supplement 3): 13–19.
10. Helgesson, G. 2012. In defense of broad consent. Cambridge Quarterly of Healthcare Ethics 21(1): 40–50.
11. Hofmann, B. 2009. Broadening consent: And diluting ethics? Journal of Medical Ethics 35(2): 125–129.
12. Holm, S. 1992. How many lay members can you have in your IRB?: An overview of the Danish system. IRB: Ethics and Human Research 14(6): 8–11.
13. Information Commisioner’s Office. 2014. Big data, artificial intelligence, machine learning and data protection. https://ico.org.uk/media/for-organisations/documents/1541/big-data-and-data-protection.pdf. Accessed June 24, 2017.
14. Institute of Medicine—Committee on the Learning Health Care System in America. 2013. Best care at lower cost: The path to continuously learning health care in America. Washington: National Academies Press.
15. Kaye, J., E.A. Whitley, D. Lund, M. Morrison, H. Teare, and K. Melham. 2015. Dynamic consent: A patient interface for twenty-first century research networks. European Journal of Human Genetics 23(2): 141–146.
16. Laurie, G., and L. Stevens. 2016. Developing a public interest mandate for the governance and use of administrative data in the United Kingdom. Journal of Law and Society 43(3): 360–392.
17. L503 1992. LOV nr 503 af 24/06/1992 Lov om et videnskabsetisk komitesystem og behandling af biomedicinske forskningsprojekter (Komiteloven) [Law on a research ethics committee system and the handling of biomedical research projects (the Committee law)].
18. L499 1996. LOV nr 499 af 12/06/1996 Lov om ændring af lov om et videnskabsetisk komitesystem og behandling af biomedicinske forskningsprojekter og lov om oprettelse af et etisk råd og regulering af visse biomedicinske forsøg (Nedsættelse, opfølgning m.v.) [Law on changes to the law on a research ethics committee system and the handling of biomedical research projects and of the law on the establishment of a council of ethics and the regulation of specific biomedical trials (Establishment, follow up etc.)].
19. L429 2000. LOV nr 429 af 31/05/2000 Lov om behandling af personoplysninger (Persondataloven) [Law on the processing of personal information (the personal data law)].
20. Luckerson, V. 2014. 7 controversial ways Facebook has used your data. Time, February 5. http://time.com/4695/7-controversial-ways-facebook-has-used-your-data/. Accessed June 24 2017.
21. Madsen, K.M., A. Hviid, M. Vestergaard, et al. 2002. A population-based study of measles, mumps, and rubella vaccination and autism. New England Journal of Medicine 347(19): 1477–1482.
22. Maidment, N. 2015.Tesco eyes majority stake sale of data unit Dunnhumby—source. Reuters Business News, February 10. http://uk.reuters.com/article/uk-tesco-dunnhumby-m-a-idUKKBN0LD1W120150209. Accessed June 24, 2017.
23. Melbye, M., J. Wohlfahrt, J.H. Olsen, et al. 1997. Induced abortion and the risk of breast cancer. New England Journal of Medicine 336(2): 81–85.
24. Otlowski, M.F.A. 2009. Developing an appropriate consent model for biobanks: In defence of “broad” consent. In Principles and practice in biobank governance, edited by J. Kaye and M. Stranger, 79–92. Farnham: Ashgate Publishing.
25. Prainsack, B., and A. Buyx. 2016. Solidarity in biomedicine and beyond. Cambridge: Cambridge University Press.
26. Ploug, T., and S. Holm. 2013. Informed consent and routinisation. Journal of Medical Ethics 39(4): 214–218.
27. . 2014. Agreeing in ignorance: Mapping the routinisation of consent in ICT-Services. Science and Engineering Ethics 20(4): 1097–1110.
28. . 2015. Meta consent: A flexible and autonomous way of obtaining informed consent for secondary research. BMJ 350: h2146.
29. . 2016. Meta consent – A flexible solution to the problem of secondary use of health data. Bioethics 30(9): 721–732.
30. Radius Kommunikation, 2016. Troværdighedsundersøgelsen 2016 [The trustworthiness survey 2016]. Købenavn: Radius Kommunikation A/S. http://radiuskommunikation.dk/wp-content/uploads/2016/11/Faktaark_Troværdighedsanalyse_2016.pdf. Accessed June 21, 2017.
31. Rasmussen, L., 1998. The Rockefeller Foundation, the Carlsberg Foundation and Danish medical biology in the interwar years. Effects on research and education throughout the 20th century. Dansk Medicinhistorisk Årbog 26: 65–79.
32. Roger, V.L., E. Boerwinkle, J.D. Crapo, et al. 2015. Strategic transformation of population studies: Recommendations of the working group on epidemiology and population sciences from the National Heart, Lung, and Blood Advisory Council and Board of External Experts. American journal of epidemiology 181(6): 363–368.
33. Rossel, P.J.H. 2017. Brystkræftprojektet—Forskning uden Informeret Samtykke [The Breast Cancer Project—Research without Informed Consent]. København: FADL’s Forlag.
34. Voosen, P. 2014. In backlash over Facebook research, scientists risk loss of valuable resource. The Chronicle of Higher Education, July 1. http://www.chronicle.com/article/In-Backlash-Over-Facebook/147447/. Accessed June 24, 2017.