Legislation

The IDIBGI Biobank is governed by the following legal framework:

  • BOE no. 298 of 14/12/1999. Organic Law 15/1999, of December 13, on the protection of personal information.
  • BOE no. 274 of 15/11/2002. Law 41/2002, of November 14, basic regulations on patient autonomy and rights and obligations regarding clinical information and documentation.
  • BOE no. 159 of 4/7/2007. Law 14/2007, of July 3 on Biomedical Research.
  • BOE no. 17 of 19/1/2008. Royal Decree 1720/2007, of December 21, which approves the Regulations implementing Organic Law 15/1999, of December 13, on the protection of personal information.
  • BOE no. 290 of 2/12/2011. Royal Decree 1716/2011, of November 18, which establishes the basic authorization and operation requirements for biobanks for biomedical research purposes and on the treatment of biological samples of human origin, and also regulates the operation and organization of the National Biobank Registry for biomedical research.
  • BOE no. 177 of 25/07/2013. Order ECC/1404/2013, of June 28, which modifies the Royal Decree 1716/2011, of November 18, which establishes the basic authorization and operation requirements for biobanks for biomedical research purposes and on the treatment of biological samples of human origin, and also regulates the operation and organization of the National Biobank Registry for biomedical research annex.
  • DOGC no. 6482 of 17/10/2013. Decree 234/2013, of October 15, which regulates the authorization for the biobanks constitution and operation for biomedical research in Catalonia and Xarxa Catalana de Biobancs.
  • BOE no. 307 of 24/12/2015. Royal Decree 1090/2015, of December 4, which regulates Clinical Trials.
  • DO L 119 de 4/5/2016. Regulation (EU) 2016/679 of the European Parliament and of the Council for the Protection of Individuals with regard to the processing of personal data and the free movement of such data and repealing Directive 95/46/EC (Regulation general data protection).
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