Basque Biobank

Frequently Asked Questions

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:

• Helps clinical staff to collect the sample and associated clinical information.
• Provides logistical support for sample processing, storage, provision and transport for projects authorised by the Biobank's ethical and scientific committees.
• Provides a meeting point for other researchers in order to establish collaborations and research projects.

 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.

• The following conventions, directives and international declarations are also applicable:
• The Universal Declaration on the Human Genome and Human Rights, UNESCO 1997.
• The Convention on Human Rights and Biomedicine, Council of Europe 1997.
• The Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data. Council of Europe, 28 January 1981.
• Directive 95/46/EC of the European Parliament and of the Council, of 24 October 1995, which broadens and specifies the protection of personal data defined by the Convention of 1981.
• The International Declaration on Human Genetic Data, UNESCO, October 2003.
• The Universal Declaration on Bioethics and Human Rights, UNESCO, 19 October 2005.

• Recommendation of the Council of Europe R(2006)4 on research with biological materials of human origin, of 15 March 2006.
• Royal Decree of Biobanks 1716/2011, of 18 November

 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.