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.
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Notes
- 1.
Blood, tissues, cells, nucleic acids, proteins, etc.
- 2.
Personal, genealogical, clinical, life style.
- 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.
- 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.
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.
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.
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.
In literature, it is also indicated with the expression narrow consent.
- 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.
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.
References
Beachamp, Tom L., and James F. Childress. 2009. Principles of biomedical ethics. New York: Oxford University Press.
Beskow, L.M., J.Y. Friedman, N. Chantelle Hardy, L. Lin, and K.P. Weinfurt. 2010. Developing a simplified consent form for biobanking. PLoS One 5 (10): e13302. https://doi.org/10.1371/journal.pone.0013302.
Biggeri, A., and M. Tallacchini. 2018. Information and communication technologies, genes, and peer-production of knowledge to empower citizens’ health. Science and Engineering Ethics 24: 871–885. https://doi.org/10.1007/s11948-015-9686-5.
Budimir, D., O. Polasek, A. Marusić, I. Kolcić, T. Zemunik, V. Boraska, A. Jerončić, M. Bodan, H. Campbell, and I. Rudan. 2011. Ethical aspects of human biobanks: A systematic review. Croatian Medical Journal 52 (3): 262–279. https://doi.org/10.3325/cmj.2011.52.262.
Budin-Ljøsne, I., H.J.A. Teare, J. Kaye, S. Beck, H.B. Bentzen, L. Caenazzo, C. Collett, F. D’Abramo, H. Felzmann, T. Finlay, M.K. Javaid, E. Jones, V. Katić, A. Simpson, and D. Mascalzoni. 2017. Dynamic consent: A potential solution to some of the challenges of modern biomedical research. BMC Medical Ethics 18 (4). https://doi.org/10.1186/s12910-016-0162-9.
Buyx, A., L. Del Salvio, B. Prainsack, and H. Völzke. 2017. Every participant is a PI. Citizen science and participatory governance in population studies. International Journal of Epidemiology 46 (2): 377–384. https://doi.org/10.1093/ije/dyw204.
Caulfied, Timpthy. 2007. Biobanks and blanket consent: The proper place of the public good and public perception rationales. King’s Law Journal 18 (2): 209–226.
Coppola, L., A. Cianflone, A.M. Grimaldi, M. Incoronato, P. Bevilacqua, F. Messina, S. Baselice, A. Soricelli, P. Mirabelli, and M. Salvatore. 2019. Biobanking in health care: Evolution and future directions. Journal of Translational Medicine 17 (127). https://doi.org/10.1186/s12967-019-1922-3.
Council of Europe. 1997. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. https://rm.coe.int/168007cf98. Accessed 1 July 2020.
———. 2005. Additional protocol to the convention on human rights and biomedicine, concerning biomedical research. https://rm.coe.int/168008371a. Accessed 1 July 2020.
———. 2016. Recommendation Rec(2006)4 of the Committee of Ministers to member stateson research on biological materials of human origin and its Explanatory Memorandum. https://www.coe.int/t/dg3/healthbioethic/Activities/10_Biobanks/Rec%282006%294%20EM%20E.pdf. Accessed 1 July 2020.
Elger, B.S., and A.L. Caplan. 2006. Consent and anonymisation in research involving biobanks. EMBO Reports 7: 661–666. https://doi.org/10.1038/sj.embor.7400740.
European Science Foundation. 2011. European Biobanks and sample repositories – Relevance to personalised medicine. http://archives.esf.org/fileadmin/Public_documents/Publications/personalised_medicine_01.pdf. Accessed 2 July 2020.
———. 2012. Personalised Medicine for the European Citizen. Towards more precise medicine for the diagnosis, treatment and prevention of disease (iPM). http://archives.esf.org/fileadmin/Public_documents/Publications/Personalised_Medicine.pdf. Accessed 2 July 2020.
Fantini, Bernardino, and Fabrizio Rufo. 2017. Il codice della vita. Una storia della genetica tra scienza e bioetica. Donzelli: Roma.
Hansson, M.G., J. Dillner, C.R. Bartram, J.A. Carlson, and G. Helgesson. 2006. Should donors be allowed to give broad consent to future biobank research? Lancet Oncology 7 (3): 266–269. https://doi.org/10.1016/S1470-2045(06)70618-0.
Hofmann, B. 2009. Broadening consent – And diluting ethics? Journal of Medical Ethics 35 (2): 125–129. https://doi.org/10.1136/jme.2008.024851.
Hofmann, Bjørn, Jan Helge Solbakk, and Søren Holm. 2009. Consent to biobank research: One size fits all? In The ethics of research biobanking, ed. Bjørn Hofmann, Jan Helge Solbakk, and Søren Holm, 3–23. Boston: Springer.
Karlsen, Jan Reinert, and Roger Strand. 2009. The ethical topography of research biobanking. In Ethics, law and society. Volume IV, ed. Jennifer Gunning, Søren Holm, and Ian Kenway. London: Routledge.
Kaye, Jane. 2015. The tension between data sharing and the protection of privacy in genomics research. In Ethics, law and governance of biobanking. National, European and international approaches, ed. Deborah Mascalzoni, 101–120. Dordrecht: Springer.
Kaye, J., P. Boddington, J. de Vries, N. Hawkins, and K. Melham. 2010. Ethical implications of the use of whole genome methods in medical research. European Journal of Human Genetics 18 (4): 398–403. https://doi.org/10.1038/ejhg.2009.191.
Kaye, Jane, Liam Curren, Nick Anderson, Kelly Edwards, Stephanie M. Fullerton, Nadja Kanellopoulou, David Lund, Daniel G. MacArthur, Deborah Mascalzoni, James Shepherd, Patrick L. Taylor, Sharon F. Terry, and Stefan F. Winter. 2012. From patients to partners: Participant-centric initiatives in biomedical research. Nature Reviews. Genetics 13 (5): 371–376.
Kaye, Jane, Edgar A. Whitley, David Lund, Michael Morrison, Harriet Teare, and Karen Melham. 2015. Dynamic consent: A patient interface for twenty-first century research networks. European Journal of Human Genetics 23 (2): 141–146.
Kegley, J.A.K. 2004. Challenges to informed consent. EMBO Reports 5: 832–836. https://doi.org/10.1038/sj.embor.7400246.
Manson, Neil C. 2019. The biobank consent debate: Why ‘meta-consent’ is not the solution? Journal of Medical Ethics 45 (5): 291–294.
National Bioethics Advisory Commission (NBAC). 1999. Research involving human biological materials: Ethical issues and policy guidance. https://bioethicsarchive.georgetown.edu/nbac/hbm.pdf. Accessed 1 July 2020.
O’Doherty, Kieran, Michael M. Burgess, Kelly Edwards, Richard P. Gallagher, Alice K. Hawkins, Jane Kaye, Veronica McCaffrey, and David E. Winickoff. 2011. From consent to institutions: Designing adaptive governance for genomic biobanks. Social Science & Medicine 73 (3): 367–374.
Parodi, Barbara. 2015. Biobanks: A definition. In Ethics, law and governance of biobanking. National, European and international approaches, ed. Deborah Mascalzoni, 15–19. Dordrecht: Springer.
Petrini, Carlo. 2010. “Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Social Science & Medicine 70 (2): 217–220.
Ploug, Thomas, and Søren Holm. 2015a. Meta consent: A flexible and autonomous way of obtaining informed consent for secondary research. BMJ 350: h2146.
———. 2015b. Going beyond the false dichotomy of broad or specific consent: A meta-perspective on participant choice in research using human tissue. The American Journal of Bioethics 15 (9): 44–46.
———. 2016. Meta consent – A flexible solution to the problem of secondary use of health data. Bioethics 30 (9): 721–732.
Reilly, P.R., M.F. Boshar, and S.H. Holtzman. 1997. Ethical issues in genetic research: Disclosure and informed consent. Nature Genetics 15: 16–20. https://doi.org/10.1038/ng0197-16.
Rufo, F., and A. Ficorilli. 2019. From Asilomar to genome editing: Research ethics and models of decision. NanoEthics 13 (3): 223–232. https://doi.org/10.1007/s11569-019-00356-1.
Salari, Pooneh, and Bagher Larijani. 2017. Ethical issues surrounding personalized medicine: A literature review. Acta Medica Iranica 55 (3): 209–217.
Salvaterra, E., L. Lecchi, S. Giovanelli, B. Butti, M.T. Bardella, P.A. Bertazzi, S. Bosari, G. Coggi, D.A. Coviello, F. Lalatta, M. Moggio, M. Nosotti, A. Zanella, and P. Rebulla. 2008. Banking together. A unified model of informed consent for biobanking. EMBO Reports 9: 307–313. https://doi.org/10.1038/embor.2008.41.
Sheehan, Mark, Rachel Thompson, Jon Fistein, Jim Davies, Michael Dunn, Michael Parker, Julian Savulescu, and Kerrie Woods. 2019. Authority and the future of consent in population-level biomedical research. Public Health Ethics 12 (3): 225–236.
Steinsbekk, Kristin Solum, Bjørn Kåre Myskja, and Berge Solberg. 2013. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem? European Journal of Human Genetics 21 (9): 897–902.
Tallacchini, M., and A. Ficorilli 2019. Dalle biobanche alle bioteche: Una innovazione profonda per la condivisione dei processi decisionali e di ricerca. (From biobank to “biotecaˮ: An innovative project to share decision-making and research process). Epidemiologia & Prevenzione 43 (1): 17–18. https://doi.org/10.19191/EP19.1.P17.014
Vayena, Effy, and Alessandro Blasimme. 2017. Biomedical big data: New models of control over access, use and governance. Bioethical Inquiry 14: 501–513.
Wendler, David. 2013. Broad versus blanket consent for research with human biological samples. Hasting Center Report 43 (5): 3–4. https://doi.org/10.1002/hast.200.
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Ficorilli, A. (2022). Personalized Medicine and Research Biobanking: From Traditional 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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