What is a Biobank?
A biobank is a repository of biological materials and associated information that are collected, processed and distributed for biomedical research purposes. As a result, each biobank has the appropriate technological infrastructure and is established within a legal and ethical framework that guarantees sample quality and patient confidentiality.
What does the Biobank do?
Once informed consent has been obtained from the patient, the Biobank:
What types of Biobank are available?
Biobanks have traditionally been classified on the basis of their proposed use (research, forensics, transplant, therapeutic, and others) or the types of sample they contain (tumours, blood, DNA, brains, etc.).
Who is responsible for operating the Basque Biobank?
As part of its founding principles, the Basque Foundation for Health Innovation and Research (BIOEF) is responsible for managing the Basque Biobank for Research. BIOEF was created by the Department of Health to promote research and innovation in the Basque public health system, as established in the BOPV of 21 February 2003.
The Department of Health, Osakidetza and Onkologikoa signed agreements with BIOEF delegating the management of their biological samples for research purposes to the Basque Biobank.
Who has authorised the constitution and operation of the Basque Biobank?
The constitution and operation of the Basque Biobank was approved on 10 June 2009 by the Basque government's Department of Health.
What main legislation affects the management of biological samples?
The legal framework that affects the management of biological samples for research purposes is Law 14/2007, of 3 July, on biomedical research, Organic Law 15/1999, of 13 December, on personal data protection, Law 41/2002, of 14 November, the basic law regulating patient autonomy and rights and obligations concerning information and clinical documentation matters, and Royal Decree 1720/2007, of 21 December, which approves the implementing regulations of Organic Law 15/1999, of 13 December, concerning the protection of temporary data.
How does a researcher benefit by requesting samples from the Basque Biobank?
The Biobank contains sample collections from specific diseases with longitudinal follow-up. This allows study development and validation times to be reduced.
Furthermore, the Basque Biobank uses a unique IT system at all its nodes that prevents donors from being duplicated at various centres whilst also allowing multicentre studies to be performed in the Basque public health system.