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Personalized Medicine and Research Biobanking: FromTraditional to New Informed Consent Generating a Need for Participatory Governance

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Part of the Human Perspectives in Health Sciences and Technology book series (HPHST,volume 3)

Abstract

Emerging personalized medicine necessitates the collection, storage and processing of an increasing number and type of human biological samples and associated data within research biobanks throughout the world, materials and data which will be used in future large-scale health-related studies. Hence, ethical concerns regarding biobanks have increased. Here, issues pertaining to autonomy and privacy will be considered, as well the related debate mainly focused on whether or not maintaining the informed consent model used in traditional health research sufficiently guarantees the dignity and rights of subjects. While at the same time serving as a good tool to obtain an appropriate balance between the research subjects’ interests and the public interest. The present paper aims to illustrate the evolutionary path of ethical reflection in this regard towards new models of informed consent, such as broad consent, dynamic consent, and meta consent. At the same time, this path generates the need for new types of governance that take into account the necessity of involving subjects in the decision-making process, especially in light of advancements in data mining and big data technologies.

Keywords

  • Personalized medicine
  • Biobank - Ethics
  • Informed consent
  • Participatory governance

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Notes

  1. 1.

    Blood, tissues, cells, nucleic acids, proteins, etc.

  2. 2.

    Personal, genealogical, clinical, life style.

  3. 3.

    The word “biobank” was used for the first time in literature by Loft-Pulsen, Cancer risk and oxidative DNA damage in man, in the “Journal of Molecular Medicine”, 1996, 74, 297 ss. to indicate the storage and conservation of biological material carried out in hospitals and in public and private structures. In 1994, the Council of Europe had used the expression human tissue banks in Recommendation N. R(94)1 of the Committee of Ministers to member states on human tissue banks, 14 march 1994, where the human tissue bank is defined as a “non-profit” organization that must guarantee the treatment, conservation and distribution of biological materials.

  4. 4.

    About origins and developments of biobanks see Fantini and Rufo (2017); Coppola et al. (2019).

  5. 5.

    It is worth highlighting that research biobanking involves industrial and commercial interests that should be carefully weighed against the interests of individual donors and society at large. This regards a huge issue that it is essential to take into account in the ethical map of research biobanking, as Karlsen and Strand have pointed out (Karlsen and Strand 2009).

  6. 6.

    Note that the need for new types of governance in the direction of forms of participatory governance is also linked to the broader ethical issues listed above, especially when questions are at stake such as scientific advances are for the benefit of what, for whom, for which interests.

  7. 7.

    In the 2000 modification of the Helsinki Declaration of the World Medical Association, art. 1 states: “The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data”.

  8. 8.

    It must be stated that, although this is the current position of the European legal framework (Council of Europe 2016), it is however controversial. Biological material, containing DNA, inevitably uniquely identifies people on a biological level and this identifying element cannot be deleted even if the material is not associated with name and surname. Furthermore, the acquisition of an ever more sophisticated genomic investigation capability and the growing possibility of linking different databases makes it more and more feasible to be able to trace the name and surname of those who gave samples and data in the presence of unidentified materials.

  9. 9.

    In literature, it is also indicated with the expression narrow consent.

  10. 10.

    The idea that one-size consent for everything does not fit every scenario had already been put forward in the following paper Hofmann et al. (2009).

  11. 11.

    It should be noted that meta consent does not take account the distinction between identifiable and non-identifiable data. Indeed it is no longer relevant in a research and social context in which it is now increasingly difficult to guarantee that non-identifiable data will remain so over time even though European legislation continues to maintain this distinction as an essential element for requesting consent or not.

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Ficorilli, A. (2022). Personalized Medicine and Research Biobanking: FromTraditional to New Informed Consent Generating a Need for Participatory Governance. In: Beneduce, C., Bertolaso, M. (eds) Personalized Medicine in the Making. Human Perspectives in Health Sciences and Technology, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-030-74804-3_13

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