title: Spanish Regulation of Biobanks.
abstract: The Spanish legal framework for the processing of samples and data with biomedical research purposes has sought to encourage scientific research, protect the right to freedom of research, and guarantee the interests of donors. The pillars of this legal framework are firstly, the duty to inform the donor in order to ensure that he or she is aware of the importance and the consequences of the donation; secondly, the control by ethics committees (RECs and External Ethics Committees of biobanks); and third, the supplementary application of the general rules on data protection. There are three different possibilities for processing samples (project, collection, and biobanks) - each one reinforcing specific consent or requiring other added guarantees. This system, which is applied consistently in the entire national territory, is producing very satisfactory results. However, there are some issues that need further policies or legal development, as the specific conditions and procedures for the international transfer of samples and data with research purposes.
authors.affiliation: Research fellow in the Public Law Department, Faculty of Law, at the University of the Basque Country in Vizcaya, Spain. She is also the Research Projects Coordinator of the Interuniversity Chair in Law and the Human Genome at the University of Deusto, University of the Basque Country, in Vizcaya, Spain (Research Group IT581-13 UPV/EHU of the Basque University System). She teaches Criminal Law in the Faculty of Law of the University of the Basque Country.
authors.forename: Pilar
authors.initials: P
authors.lastname: Nicolás
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence*; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000331:legislation & jurisprudence; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D006801:Humans; D013030:Spain