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The Ethics of Biomedical Big Data pp 119–137Cite as

Many Have It Wrong – Samples Do Contain Personal Data: The Data Protection Regulation as a Superior Framework to Protect Donor Interests in Biobanking and Genomic Research

Part of the Law, Governance and Technology Series book series (LGTS,volume 29)

Abstract

Genomic research relies on the availability of genomic data. Detached biological samples, stored in facilities known as biobanks, are the source of this data. Donors have interests in these samples. In particular, donors have interests in samples by virtue of the personal data they contain. In relation to this observation, this article puts forward three arguments. First: The current European legislative framework relating to samples is inadequate. This inadequacy results from not understanding samples in terms of the information they contain. Second: European data protection law, in particular as outlined in the forthcoming Data Protection Regulation, might be looked as a source of solutions. However, whether data protection law can apply to samples at all remains a subject of debate. One key argument supports the position that it cannot: Samples are not data, but rather are physical mater, and therefore can only a source of data. Third: The assertion that ‘samples are not data, but rather only physical matter’ is flawed. Samples do contain data – DNA is data. DNA is understood as information both popularly and in the genetic sciences. In fact, even in informatics, DNA can be understood as data.

Keywords

  • Personal Data
  • Data Protection
  • Authoritative Source
  • Genetic Sample
  • Genetic Science

These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Notes

  1. 1.

    For a definition see National Health and Medical Research Council (2010).

  2. 2.

    The first full genome was sequenced by the Human Genome Project in 2001. The sequencing process took 10 years, required a $3bn investment and was the product of the collaborative efforts of 200 scientists from institutions located all over the globe (International Human Genome Consortium et al. 2001, pp. 860–921). By comparison, in 2014, Illumina, a manufacturer of genetic sequencing equipment, brought out the Illumina Hi Seq X-10 sequencing machine. According to Illumina’s product description, the High Seq X-10 is capable of sequencing 49 genomes per day at a cost of only $1000 each (Illumina 2015).

  3. 3.

    For example, sequenced genomic data may be used in Genome Wide Association Survey research. In such research, thousands of genomes from individuals displaying a certain trait are compared with thousands of other genomes from individuals not displaying this trait. The comparison of genomes allows the production of generalized information about significant points of difference between the two sets of genomes. These points of difference hold information as to the genetic basis for the studied trait. See Kaye (2012, pp. 36–38).

  4. 4.

    If knowledge is available as to the significance of a certain type of genetic architecture, the detection of that architecture in a specific genome can reveal information about the person from whom the genome came. Certain of the genetic characteristics observed may be biographically highly significant – for example, those relating to disease predisposition. See Hallinan and De Hert (2015).

  5. 5.

    Asslaber observes that ‘in a genome scan for a genetic polymorphism associated with a certain disease, DNA of about 10,000 diseased individuals should be analysed’ (Asslaber and Zatloukal 2007, p. 194). For any single biobank to collect this number of samples of individuals displaying the relevant form of the disease will be a long and arduous process – especially for rare diseases. Nevertheless, reaching a critical mass of samples can be significantly expedited ‘if biobanks cooperate … so that cases from different biobanks can be combined’ (Asslaber and Zatloukal 2007, p. 194). Further, certain approaches to research will require the availability of specific types of samples for which certain genetic or environmental variables have been removed – for example, samples of a particularly homogenous ethnic population. Identifying relevant biomarkers becomes much simpler when variation can be minimized. Availability of such samples may be geographically specific, although research may take place globally. To facilitate such research, biobanks need to exchange samples and collaborate across borders.

  6. 6.

    Telethon Network of Genetic Biobanks. http://www.biobanknetwork.org/members.php. Accessed 03 July 2015.

  7. 7.

    Perhaps the two most prominently discussed networks are the EuroBioBank network for scientists studying rare diseases and the Biobanking and BioMolecular resources Research Infrastructure (BBMRI) (Eurobiobank. http://www.eurobiobank.org/en/partners/partners.htm Accessed 03 July 2015; BBMRI. http://bbmri-eric.eu/memberstates. Accessed 03 July 2015). BBMRI currently consists of over 280 organisations and is particularly interesting as it represents a directed effort by the European Commission to create a European biobanking network. Finally, there are global networks, such as the Public Population Project in Genomics (P3G) which boasts truly global membership (Public Population Project in Genomics. http://p3g.org/membership/institutional-members. Accessed 03 July 2015).

  8. 8.

    All three text drafts thus far available and compared at: http://statewatch.org/news/2015/apr/eu-council-dp-reg-4column-2015.pdf. Accessed 03 July 2015.

  9. 9.

    See Chapter VI in each version: http://statewatch.org/news/2015/apr/eu-council-dp-reg-4column-2015.pdf. Accessed 03 July 2015.

  10. 10.

    See Article 9 in each version: http://statewatch.org/news/2015/apr/eu-council-dp-reg-4column-2015.pdf. Accessed 03 July 2015.

  11. 11.

    See Article 2(1) or equivalent in each version: See Chapter VI in each version: http://statewatch.org/news/2015/apr/eu-council-dp-reg-4column-2015.pdf. Accessed 03 July 2015.

  12. 12.

    See Article 4(1) or 4(2) in each version (there are minor language differences between versions, but these do not change the applicability of the analysis): See Chapter VI in each version: http://statewatch.org/news/2015/apr/eu-council-dp-reg-4column-2015.pdf. Accessed 03 July 2015.

  13. 13.

    See Recital 25(a) in the Council version: http://statewatch.org/news/2015/apr/eu-council-dp-reg-4column-2015.pdf. Accessed 03 July 2015.

  14. 14.

    See Article 2 of each version: http://statewatch.org/news/2015/apr/eu-council-dp-reg-4column-2015.pdf. Accessed 03 July 2015.

  15. 15.

    The one place this idea seems to have been given more extensive legal consideration is; in the Australian Law Reform Commission and Australian Health Ethics Committee, ‘Essentially Yours: The Protection of Human Genetic Information in Australia’ report (2003, p. 268). Unfortunately, the analogy is only partially outlined, and its significance is not carried forward in further analysis.

  16. 16.

    See, for example, the numerous information metaphors in US President Clinton’s; ‘Remarks made by the President … on the Completion of the First Survey of the Entire Human Genome Project’ (2000).

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Author information

Authors and Affiliations

  1. FIZ Karlsruhe – Leibniz Institute for Information Infrastructure, Hermann-von-Helmholtz-Platz 1, Eggenstein-Leopoldshafen, 76344, Germany

    Dara Hallinan

  2. Law, Science, Technology and Society (LSTS), Vrije Universiteit Brussel-RC-Juri, Building B, Room 4B317, Pleinlaan 2, Brussels, 1050, Belgium

    Paul De Hert

Authors
  1. Dara Hallinan
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  2. Paul De Hert
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Correspondence to Dara Hallinan .

Editor information

Editors and Affiliations

  1. Oxford Internet Institute, University of Oxford, Oxford, United Kingdom

    Brent Daniel Mittelstadt

  2. Oxford Internet Institute, University of Oxford, Oxford, United Kingdom

    Luciano Floridi

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Hallinan, D., De Hert, P. (2016). Many Have It Wrong – Samples Do Contain Personal Data: The Data Protection Regulation as a Superior Framework to Protect Donor Interests in Biobanking and Genomic Research. In: Mittelstadt, B., Floridi, L. (eds) The Ethics of Biomedical Big Data. Law, Governance and Technology Series, vol 29. Springer, Cham. https://doi.org/10.1007/978-3-319-33525-4_6

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