Abstract
Advances at the intersection of information technologies, data science, biomedical research and health care, have discomfiting implications for reliance on the conventional tools of data protection and information governance. A 2015 report from the Nuffield Council on Bioethics proposes an approach to the design and governance of data initiatives that is both dynamic and cooperative in order to address the fluctuating interests engaged by uses of data in which there is a public interest. This chapter develops elements of that approach to argue that organising data initiatives as social practices that respect certain principles can help to establish and meet morally reasonable expectations about data use, by grounding them in a dynamic relationship between social norms, individual freedoms and professional duties.
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Notes
- 1.
In the interests of economy these arguments, which are elaborated elsewhere (e.g. Nuffield Council on Bioethics 2015), are not developed or explored here. It will be assumed to be common ground that the concepts of anonymisation and consent are problematic for Big Data, in that it is implausible to suggest that anonymisation can be robust without further qualification and a mistake to believe that consent guarantees autonomy or is either necessary or sufficient to secure the protection of all relevant personal interests.
- 2.
It is probably worth remarking that, nevertheless, perhaps the biggest sources of negative impact from misuse of data remain errors of competence and maladministration (Laurie et al. 2014).
- 3.
These were, respectively, propositions 15 and 16 in the Nuffield report (Nuffield Council on Bioethics 2015).
- 4.
Manson and O’Neill make the distinction between information (thought as content) and informing, the effect of which relies substantially on a background of knowledge, competencies and dispositions (Manson and O’Neill 2007).
- 5.
Finding a use of data that is mutually acceptable to those whose morally relevant interests are at stake gives rise to the requirement that the expectations about the use of data form a coherent ‘set’, one that does not contain contradictory elements (although surpassed contradictions may be preserved at levels below that of the collective agreement). Furthermore, respect for those whose interests are at stake (which, in some cases are protected by rights and entitlements) means that it must be one that is capable of being articulated (‘publicly statable’) in a way that is meaningful, and understandable to those whose interests are at stake, such that an account of decisions can be given to them that they would recognise as reasonable (Daniels and Sabin 1997; Habermas 1990).
- 6.
The Nuffield report remarks, as others have done, on the imprecise and loaded use of language in the relevant literature. ‘Data sharing’, with its connotations of beneficence and mutuality, is an example of this although the term seems appropriate in this context where the norms of exclusivity are established through the involvement of relevant interests to which it restores an appropriate level of moral agency.
- 7.
Of course, second order questions arise in each case (for example, in the first case, about the origin or justification of the ‘independent’ standard; in the second, regarding the fairness of the process). The report does not try to resolve these but it keeps them in play. Consequently the process is reflexive and interminable: its conclusions are provisional and persuasive rather than decisive, and the standard is treated as conventional rather than categorical.
- 8.
This is not only those from whom the data may have been collected but also those to whom people the findings might be applied. If the findings inform decisions relating to public policy, this entails a case for the engagement of the ‘public’ in general (or their representatives).
- 9.
In this respect it has advantages over aggregative approaches that simply gather preferences as a basis for decision making (e.g. voting) or are simply designed as a take-it-or-leave-it ‘offer’ to optimise the number or type of those consenting to participate. Nevertheless, owing to the fact that it is not practical to involve all those who have an interest, it is still necessarily only indicative (rather than representative).
- 10.
Interestingly, this case has been made, although not entirely persuasively, in relation to the sequestration of health data for Big Data analysis supporting biomedical research, health service planning and delivery (e.g. predictive interventions) and policy. The case is broadly that, without the gains in efficiency promised by better data use, the National Health Service in England will become unaffordable and cease to exist, imperilling public health.
- 11.
Prainsack and Buyx offer a descriptive ethics of solidarity in Solidarity: reflections on an emerging concept in bioethics (Prainsack and Buyx 2011).
- 12.
In preparing the report we proposed and ‘empirical typology’ of data initiatives as a basis for reflection.
- 13.
“A data initiative should be subject to effective systems of governance and accountability that are themselves morally justified. This should include both structures of accountability that invoke legitimate judicial and political authority, and social accountability arising from engagement of people in a society. Maintaining effective accountability must include effective measures for communicating expectations and failures of governance, execution and control to people affected and to the society more widely.” (Nuffield Council on Bioethics 2015)
- 14.
There is not sufficient space here to engage fully with the question of dynamic consent. It should be sufficient, however, to observe that dynamic consent is not a new form of consent: consent has always been ‘dynamic’, in the sense of continuously subsisting, capable of withdrawal or subject to the imposition of conditions, etc. The introduction of electronically supported consent portals merely add a facility of communication to it that, granted, offer a number of advantages (ease of use, communication of results, etc.). They do not change the fundamental choices available: what they do is ‘unstick’ the inertia of ‘up front’ consent recorded on paper consent forms and undermine the rationale for the ‘compromise’ (if compromise it really is) of ‘broad’ consent (although dynamic consent can also be ‘broad’: again, it adds nothing new). The important question of policy is not about the choice to exercise freedoms but the determination of what freedoms may be exercised. The same point applies, mutatis mutandis, to solidarity: the voluntary expression of a more social disposition, a ‘willingness to carry costs on behalf of others’ (Buyx and Prainsack 2011), while it may be something to be encouraged, does not overturn the individualistic model of consent. A solidarity-based system is one in which the distribution of options to bear costs and enjoy benefits is distributed more fairly, and may give those who bear the greatest costs a say in that distribution.
References
Bateson, Gregory. 1972. Steps to an ecology of mind: Collected essays in anthropology, psychiatry, evolution, and epistemology. San Francisco: Chandler.
Beck, Ulrich. 1992. Risk society: Towards a new modernity. London: SAGE Publications Ltd.
Bennett, Craig M., Abigail A. Baird, Michael B. Miller, and George L. Wolford. 2009. Neural correlates of interspecies perspective taking in the post-mortem Atlantic Salmon: An argument for multiple comparisons correction. http://prefrontal.org/files/posters/Bennett-Salmon-2009.pdf. Accessed 11 June 2015.
Business, Innovation and Skills, UK Department for. 2011. Strategy for UK life sciences. London: Department for Business, Innovation & Skills.
Caldicott Committee. 2013. Information: to share or not to share? The information governance review. https://www.gov.uk/government/publications/the-information-governance-review. Accessed 5 Oct 2015.
Daniels, Norman, and James Sabin. 1997. Limits to health care: fair procedures, democratic deliberation and the legitimacy problem for insurers. Philosophy and Public Affairs 26(4): 303–350.
Faden, Ruth R., Nancy E. Kass, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom 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.
Genomics England Ltd. 2015. Genomics England and the 100,000 Genomes Project. http://www.genomicsengland.co.uk/the-100000-genomes-project/ Accessed 24 June 2015.
Habermas, Jürgen. 1990. Moral consciousness and communicative action, trans. C. Lenhardt and S. Weber Nicholsen. Cambridge: Polity.
Kaye, Jane, Edgar A. Whitley, David Lund, Michael Morrison, Harriet Teare, and Karen Melham. 2014. Dynamic consent: A patient interface for twenty-first century research networks. European Journal of Human Genetics 23(2): 141–146.
Laurie, Graeme, Kerina H. Jones, Leslie Stevens, and Christine Dobbs. 2014. A review of evidence relating to harm resulting from uses of health and biomedical data. http://nuffieldbioethics.org/project/biological-health-data/evidence-gathering/. Accessed 24 June 2015.
Manson, Neil, and Onora O’Neill. 2007. Rethinking informed consent in bioethics. Cambridge: Cambridge University Press.
Mayer-Schönberger, Viktor, and Kenneth Cukier. 2013. Big data: A revolution that will transform how we live, work and think. London: John Murray.
Nuffield Council on Bioethics. 2012. Emerging biotechnologies: technology, choice and the public good. London: Nuffield Council on Bioethics.
Nuffield Council on Bioethics. 2015. The collection, linking and use of data in biomedical research and health care: Ethical issues. London: Nuffield Council on Bioethics.
O’Neill, Onora. 2002. Autonomy and trust in bioethics. Cambridge: Cambridge University Press.
Parker, Michael. 2007. Deliberative bioethics. In Principles of health care ethics, ed. Ashcroft Richard, Dawson Angus, Draper Heather, and John McMillan. Chichester: Wiley.
Prainsack, Barbara, and Alena Buyx. 2011. Solidarity: Reflections on an emerging concept in bioethics. London: Nuffield Council on Bioethics.
Prainsack, Barbara, and Alena Buyx. 2013. A solidarity-based approach to the governance of research biobanks. Medical Law Review 21: 71–91.
Taylor, Mark J. 2012. Genetic data and the law: A critical perspective on privacy protection. Cambridge: Cambridge University Press.
Taylor, Mark J., and Natasha Taylor. 2014. Health research access to personal confidential data in England and Wales: Assessing any gap in public attitude between preferable and acceptable models of consent. Life Sciences, Society and Policy 10: 15.
Vertesi, Janet. 2014. My experiment opting out of big data made me look like a criminal. Time. http://time.com/83200/privacy-internet-big-data-opt-out/. Accessed 1 July 2015.
Wanless, Derek. 2002. Securing our future health: Taking a long-term view. Final report. London: HM Treasury.
Wanless, Derek, John Appleby, Anthony Harrison, and Darsham Patel. 2007. Our future health secured? A review of NHS funding and performance. London: King’s Fund.
Willetts, David. 2013. Eight great technologies. London: Policy Exchange.
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Mills, P. (2016). Ethical Reuse of Data from Health Care: Data, Persons and Interests. 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_18
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