Regulating Biobanks: An ethical analysis of the Spanish law and the new challenges of the big data-driven biomedical research
DOI:
https://doi.org/10.1344/rbd2021.53.32834Keywords:
biobancos, bioética, principios, derecho, biomedicina, datos masivosAbstract
In the European landscape, Spain represents a positive reference point when it comes to biobank regulation. Indeed, at the beginning of XXI century, the Spanish legislation has promptly responded to challenges posed by new biotechnologies and advances in genomics in the field of biomedical research by enacting in 2007 the Ley de Investigación Biomédica in order to keep up with the paradigm shift. Over the past 10 years, this Spanish framework along with the Real Decreto 1716/2011 has hold the merit to tackle the most controversial ethical issues related to use of human samples and personal data in biomedical research and biobanking (e.g. broad consent, secondary uses, governance, etc.). However, today the regulation of biomedical research and biobanks has to deal with big data, artificial intelligence and data-intensive research which have brought a number of challenges and controversies. The aim of this paper is two-fold. First, I will analyse from an ethical point of view the merits of Spanish regulation on biobanking in order to draw some lessons for the still unregulated situation in other Member States. Secondly, I will discuss the big data paradigm shift in biomedical research and question if the ethical and legal framework introduced the Spanish law at the beginning of the century is still able to hold the ground with the new contextual and societal challenges. In this respect, I will identify some opportunities for implementation and suggest strategies to achieve them in the specific context of biobanks.
References
Arias-Diaz, J., Martín-Arribas, M. C., Del Pozo, J. G., & Alonso, C. (2013). Spanish regulatory approach for Biobanking. European Journal of Human Genetics, 21(7), 708-712.
Blasimme, A., & Vayena, E. (2019). Towards Adaptive Governance in Big Data Health Research: Implementing Regulatory Principles. Cambridge Handbook of Health Research Regulation. Cambridge University Press, Cambridge, UK–Forthcoming.
Casabona, R. (2007). Utilización de muestras biológicas humanas con fines de investigación biomédica y regulación de biobancos. En: Sánchez-Caro J, Abellán F, editores. Investigación biomédica en España. Aspectos bioéticos, jurídicos y científicos. Granada: Comares.
Casado, A., and Etxeberria, I. 2009. Consent by research ethics committees: The new law on bio- medical research in Spain. In Principles and practice in biobank governance, ed. Jane Kaye and Mark Stranger, 93–103. Farnham: Ashgate.
Casado, A., and J.A. Seoane. 2008. Alternative consent models for biobanks: The new Spanish law on biomedical research. Bioethics 22: 440–447.
Casado, A. 2009. Towards a comprehensive concept of patient autonomy. The American Journal of Bioethics 9(2): 37–38.
Casado M, Buisán L, Llácer RM, editores. Documento sobre bioètica y Big Data de salud: explotación y comercialización de los datos de los usuarios de la sanidad pública. Obser- vatori de Bioètica I Dret. Catedra UNESCO de Bioètica de la Universitat de Barcelona. Barcelona: Ed. UB; 2015. Disponible en: http://www.bioeticayderecho.ub. edu/sites/default/files/doc big-data.pdf
Casado, M. (2017). ¿ Gratuidad o precio?: Sobre el cuerpo humano como recurso. Capítol 1 del llibre: Casado, María (coord.). De la solidaridad al mercado: el cuerpo humano y el comercio biotecnológico. Edicions de la Universitat de Barcelona. 2017.(ISBN: 978-84-475-4193-5). pp 17-34.
Caulfield T, Burningham S, Joly Y, et al. A review of the key issues associated with the commercialization of biobanks. J Law Biosci. 2014; 1(1):94–110.
Cohen, J. E. (2012). What privacy is for. Harv. L. Rev., 126, 1904.
Costa, F. F. (2014). Big data in biomedicine. Drug discovery today, 19(4), 433-440.
da Rocha, A. C. (2015). Biobank governance in Spain: From the autonomy of research ethics committees to the autonomy of lay people. In Ethics, Law and Governance of Biobanking (pp. 227-239). Springer, Dordrecht.
de Lecuona, I., & Villalobos‐Quesada, M. (2018). European perspectives on big data applied to health: The case of biobanks and human databases. Developing world bioethics, 18(3), 291-298.
de Lecuona Ramírez, I. D. (2017). La tendencia a la mercantilización de partes del cuerpo humano y de la intimidad en investigación con muestras biológicas y datos (pequeños y masivos). Capítol X del llibre: Casado, María (coord.). De la solidaridad al mercado: el cuerpo humano y el comercio biotecnológico. Edicions de la Universitat de Barcelona. 2017.(ISBN: 978-84-475-4193-5). pp 267-295.
Dove, E. S. (2018). The EU General Data Protection Regulation: Implications for International Scientific Research in the Digital Era. The Journal of Law, Medicine & Ethics, 46(4), 1013-1030.
European Commission. Biobanks for Europe. A Challenge for Governance; 2012. Available from: http://www.coe.int/t/dg3/ healthbioethic/Activities/10_Biobanks/biobanks_for_Europe.pdf. Accessed June 5, 2015.
Farnós, I. A., Jiménez, P. N., & de Uzquiano, E. F. (2016). Aspectos éticos y legales relativos al tratamiento de muestras biológicas humanas en ensayos clínicos con medicamentos. Propuesta de criterios de evaluación para los Comités Éticos de Investigación Clínica. Revista Española de Medicina Legal, 42(3), 105-119.
Floridi, L. (2018). Soft ethics and the governance of the digital. Philosophy & Technology, 31(1), 1-8.
García, N. D., & Purriños, N. C. (2014). Biobanks and their importance in the clinical and scientific fields related to Spanish biomedical research. Reumatología Clínica (English Edition), 10(5), 304-308.
García-Merino, I. M., Consuegra, I., Jiménez, J. L., & Muñoz-Fernández, M. Á. (2015). Specific legislation on biobanks in Spain. Biopreservation and Biobanking, 13(3), 207-211.
Gille, F., Vayena, E., & Blasimme, A. (2020). Future-proofing biobanks’ governance. European Journal of Human Genetics, 1-8.
Gil 2011, Revista de Bioetica y Derecho
Gómez Sánchez, Y. (2007). La libertad de creación y producción científica en la ley de investigación científica: Objeto, ámbito de aplicación y principios generales de la ley. Investigación biomédica en España: Aspectos Bioéticos, Jurídicos y Científicos.
ISBER (International Society for Biological and Environmental Repositories) 2012 Best Practices for repositories: collection, storage, retrieval, and distribution of biological materials for research. Biopreserv Biobank. 2012;10:79–16
Jiménez, P. N., De Uzquiano, E. F., & Farnós, I. A. (2018). Biobank External Ethics Committees (BEEC) in Spain. Nature, functions and operating procedures. BioLaw Journal-Rivista di BioDiritto, 13(2), 205-216.
Nicolás, P., and Romeo Casabona, C.M., eds. 2009. Controles éticos en la actividad biomédica: Análisis de situación y recomendaciones. Madrid: Instituto Roche.
Nicolás, P. (2015). Spanish regulation of biobanks. The Journal of Law, Medicine & Ethics, 43(4), 801-815.
OECD - Guidelines on Human Biobanks and Genetic Research Databases, 2009. Available at: http://www.oecd.org/sti/emerging-tech/guidelines-for-human-biobanks-and-genetic-research-databases.htm . Last Access:
Price II, W. N. (2019). Biobanks as innovation infrastructure for translational medicine. In Global Genes, Local Concerns. Edward Elgar Publishing.
Sánchez-Caro, J., & Abellan, F. (2007). Investigación Biomédica en España Aspectos Bioéticos, Jurídicos y Científicos. Ed. Comares.
Seoane Rodríguez, J.A., and A. Casado da Rocha. 2008. Consentimiento, biobancos y Ley de investigación biomédica. Revista de Derecho y Genoma Humano 29: 131–150.
Staunton, C., Slokenberga, S., & Mascalzoni, D. (2019). The GDPR and the research exemption: considerations on the necessary safeguards for research biobanks. European Journal of Human Genetics, 1.
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