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Researchers’ Duty to Share Pre-publication Data: From the Prima Facie Duty to Practice

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The Ethics of Biomedical Big Data

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

Abstract

The purpose of this chapter is to offer an ethical investigation into whether researchers have a duty to share pre-published bio-medical data with the scientific community. The central questions of the chapter are the following: do researchers have a prima facie duty to share pre-published data? And if so, what stakes and aspects of a concrete situation need to be taken into consideration in order to assess whether and to what extent researchers’ prima facie duty to share data applies? We will argue that based upon their basic duties to benefit society and to promote scientific knowledge, researchers have a prima facie duty to share data. We will also argue that in order to determine whether the prima facie duty applies in practice it is indispensable to take into account the stakes of the persons concerned as well as context dependent aspects. The chapter’s overall goal is to build an analytical and ethical framework that helps to assess with regard to concrete situations whether researchers’ duty to share data applies. To this end we analyse the concept of data sharing and clarify what data sharing might imply in practice. To offer an overview of the different stakeholders’ concerns we will analyse the normative-informational environment in which data producing researchers (to whom the prima facie duty to share data applies) are usually situated. In the last step we focus on the ethically relevant context dependent aspects and illustrate how they affect researchers’ prima facie duty to share data and stakeholders’ potentially conflicting stakes.

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Notes

  1. 1.

    The following reconstruction is based upon Kaye et al. (Kaye et al. 2009; Kaye and Hawkins 2014).

  2. 2.

    For a typology of ways of breaching anonymity see Erlich and Narayanan (2014).

  3. 3.

    For the United Kingdom see Pryor (2009); Mauthner reports that in the UK making research data available to other users is a central element of the Research Council’s remit and of Common Principles on Data Policy issued by Research Councils UK (RCUK) (Mauthner 2013).

  4. 4.

    For general overviews on barriers to data sharing see van Panhuis et al. (2014), Simpson et al. (2014), Sane and Edelstein (2015).

  5. 5.

    One needs to distinguish the terms “common good” and “public good“. We refer to the common good as what benefits society, whereas public good is a specific economical term referring to just one determined and formally defined kind of goods (Bialobrzeski et al. 2012).

  6. 6.

    For the principles of nonmaleficence and beneficence (with focus on the relation between physician and patient) see Beauchamp and Childress (2009).

  7. 7.

    This holds particular for researchers in liberal societies which warrant researchers freedom of research and grant them particular space and authority in the public discourse.

  8. 8.

    Almost all authors who (briefly) consider data sharing as ethical or scientific imperative, obligation or duty base their claim – among other things – on its (potential) benefit for science and the public (Knoppers et al. 2014; Langat et al. 2011; Brakewood and Poldrack 2013; Chalmers et al. 2014).

  9. 9.

    For the (legal) importance of the protection against (potential) surveillance by governmental agencies see the safe harbor judgment by the Court of Justice of the European Union (2015).

  10. 10.

    Here, we will not mention the very work of collecting and elaborating data which of course is a practical prerequisite for data sharing. We will refer to the work aspect and its ethical relevance in Sects. 6 and 7.

  11. 11.

    This approach is inspired by Floridi’s concept of infosphere (Floridi 2008).

  12. 12.

    But see also Mauthner’s critically view of the conflict in the United Kingdom between the Freedom of Information Act and researchers’ right to keep data confidential (Mauthner 2013).

  13. 13.

    Yet, at the meta-ethical level we remark that it is in general more challenging to ethically justify a duty which implies the violation of another duty than to justify the legitimacy, that is the allowance, of an act that implies the violation of a duty. In this sense the first question would be whether and under which circumstances a data producer may share the data of donors who were not asked for consent. The question whether a data producer has the ethical duty to share the data requires particularly strong reasons and justifications.

  14. 14.

    For an overview on consent with regard to big data driven biomedical research see Mittelstadt (Mittelstadt and Floridi 2015).

  15. 15.

    Broad consent is in itself a rather broad concept. It might be approximately conceived as lying on a scale between specific consent at the one end and open consent at the other end (Hansson 2009). Whereas traditional consent always addressed and defined the relevant aspects of the study in question, broad consent means consent to a framework of numerous future as well as yet unknown studies (Steinsbekk et al. 2013). Broad consent is a practical and thus attractive way to garner the consent of patients or participants for research that includes secondary uses of their bio-material (tissue) and their data (Hansson 2009). Data sharing to allow secondary data uses is thus not the only topic usually addressed by broad consent and by the discussions about broad consent. However, one might consider data sharing the most delicate point of the broad consent practice. Data can easily be reproduced and transferred and thus bears more risks of abuse and confidentiality breaches for the data donor than the distribution of tissue which is a limited resource. Criticisms of broad consent state that broad consent is not informed consent, that “broad informed consent” is a contradiction in terms (Hofmann 2009), and that the more general consent is, the less informed it is (Árnason 2004). Some conclude that broad consent conflicts with respect for persons and respect for autonomy (Caulfield 2007).

  16. 16.

    For a similar position see Hansson et al. (2006).

  17. 17.

    For a theoretical framework of our position concerning governance, researchers’ responsibilities and the informed consent process with regard to data sharing, as well for the translation of this position into a code of conduct for non-physician scientists and a consent template form, see EURAT position paper (EURAT 2013).

  18. 18.

    Brakewood and Poldrack speak of a “fiduciary relationship” between researcher and a research participant (Brakewood and Poldrack 2013).

  19. 19.

    It might be philosophically inspiring to link the bioethical concept of stewardship for biomedical data to a more general concept from Floridi’s information ethics, that is to his concept of creative stewards as referring to moral agents within the infospshere (Floridi 2008).

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Acknowledgement

Funding: The first author’s contribution to the article was supported by a funding (01GP1404A) of the German Federal Ministry of Education and Research. Acknowledgments: We thank Sebastian Schleidgen for commenting on an earlier draft, Prof. Dr. Stefan Fröhling and Prof. Dr. Rudi Balling for inspiring discussions, and Simone Dippel for support in literature research.

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Authors and Affiliations

  1. University of Heidelberg, Heidelberg, Germany

    Christoph Schickhardt Ph.D

  2. University of Bamberg, Bamberg, Germany

    Christoph Schickhardt Ph.D

  3. Department of Philosophy, Brandeis University, Rabb 303, MS 055, 415 South Street, Waltham, MA, 02453, USA

    Nelson Hosley

  4. National Center for Tumor Diseases, University Hospital of Heidelberg, Heidelberg, Germany

    Eva C. Winkler M.D., Ph.D

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  1. Christoph Schickhardt Ph.D
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Correspondence to Christoph Schickhardt Ph.D .

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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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Schickhardt, C., Hosley, N., Winkler, E.C. (2016). Researchers’ Duty to Share Pre-publication Data: From the Prima Facie Duty to Practice. 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_14

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