Publicación: Spain
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2023-12-27
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info:eu-repo/semantics/openAccess
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Springer
Resumen
In Spain, two laws regulate biobanks: the Biomedical Research Law and the Biobanks Regulation (Royal Decree 1716/2011) These laws establish the requirements for the authorisation and operation of biobanks for biomedical research purposes and for the processing of sample biologics of human origin. The Spanish law on biomedical research establishes relevant rules for the correct use of biological samples and for the use, treatment and conservation of genetic data, for which it establishes additional requirements to those provided by the GDPR. The use of biological samples assumes consent expressed for a specific investigation, and a new expression of consent is required for the use of biological samples for other research not related to the initial purpose for which consent was granted. In Spain, the processing of health, genetic and biometric data is lawful for scientific research purposes with the prior consent of the data subject. However, the legislation supports research by allowing broad consensus that facilitates related future research; and for the reuse of personal data for other health and biomedical research purposes by specifying that reuse can occur when the data is used for purposes or areas of research related to the area in which the initial study was permitted. Some guarantees in support of the legitimacy of the processing of pseudonymised data for health and biomedical research are required by the national law, including that the use of pseudonymised personal data for public health and biomedical research purposes is previously submitted to the research ethics committee set up by sector legislation.
Descripción
Acepted Manustrict-AM of Chapter of the book: “GDPR Requirements for Biobanking Activities Across Europe”. 2023, Springer 617-626. https://doi.org/10.1007/978-3-031-42944-6
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Citación
Sarrión Esteve, J. (2023). Spain. In: Colcelli, V., Cippitani, R., Brochhausen-Delius, C., Arnold, R. (eds) GDPR Requirements for Biobanking Activities Across Europe. Springer, Cham. https://doi.org/10.1007/978-3-031-42944-6_72
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Facultad de Derecho
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Derecho Constitucional