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

• Published in: Journal of bioethical inquiry Vol. 14; no. 4; pp. 515 - 525
• Main Authors: Holm, Søren, Ploug, Thomas
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.12.2017
• Subjects: Big data; Biobanks; Data protection; Ethics; Informed consent (Medical law); Medical Law; Medicine; Medicine & Public Health; Moral and ethical aspects; Symposium: Ethics and Epistemology of Big Data; Theory of Medicine/Bioethics; Databases; Meta consent; Data protection; Biobanks; Research use of health data; Informed consent; Big data
• ISSN: 1176-7529; 1872-4353; 1872-4353
• DOI: 10.1007/s11673-017-9810-0

Denmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported by facilitative regulation that allows data to be used without the consent of data subjects. However, in the future much of the data will not be held by public authorities but by private companies. What are the implications of this shift for the governance of the research use of the data? This paper will argue that increased involvement of Research Ethics Committees and better training of researchers are necessary; and that some form of consent will have to be re-introduced. Four different consent models will be discussed: Opt-Out, Broad/Blanket consent, Dynamic consent, and Meta consent. It will be argued that a governance model including a possibility for citizens to make meta-choices strikes the best balance between individual and public interests.