biobank

Legislatoin

Research

According to the Law of Biomedical Research, approved 3 July 2007 and the Spanish Royal Decree RD1716/2011 of 18 November a biobank is a non-profit public or private establishment that houses one or several collections of human biological samples destined for biomedical research and organized in a technical unity with criteria of quality, order and destination independently of whether it contains samples for other ends.

Both regulations, including the Spanish Royal Decree 234/2013 of 15 October of the "Diari Oficial de la Generalitat de Catalunya", regulate for the ownership, organization, channels of authorization and register as well as the requirements for obtaining, depositing and releasing samples to third parties of Biobanks and collections of samples.

Protection of Data

Three laws protect the rights of the individual regarding his or her personal data: The Law 41/2002 Autonomy of the Patient, the Law 15/1999 Protection of Personal Data and The Royal Decree 1729/2007 21 December.  These laws require that priority is given to respect, protection of identity and dignity of people, they recognize the complete autonomy of the individual, the need for confidentiality by those with access to personal data and the principle of gratuity free from payment of donations of any type of biological material destined for research.  

The activities of the Biobank are this strictly regulated and defined by law and the organization must regularly review procedures and insure that all vigilance and precautions required are applied.