Regulatory Framework

• Law 41/2002, of 14 November, basic regulating patient autonomy and rights and obligations in terms of clinical information and documentation.
• Order SCO/393/2006, of February 8, which establishes the organization and operation of the National Bank of Cell Lines.
• Law 14/2007 on Biomedical Research.
• Royal Decree 1716/2011, of 18 November, which establishes the basic requirements for the authorisation and operation of biobanks for research purposes treatment of biological samples of human origin, and the operation and organization of the National Register of Biobanks for biomedical research is regulated.
• Decree 1/2013 of January 8, which regulates the authorization for the constitution and operation of Biobanks for research purposes in Andalusia and the Biobank of the Public Health System of Andalusia is created.
• Order ECC/1404/2013, of 28 June, amending the annex to Royal Decree 1716/2011, of 18 Spanish Royal Decree 1716/2011, of 18th November, which establishes the basic requirements for the authorisation and operation of biobanks for biomedical research purposes and the treatment of biological human samples, and regulates the operations and organisation of the Spanish National Register of Biobanks for biomedical research. Order of June 15, 2015, by which the personal data file called "Sample Donors for Biomedical Research in Andalusia" is created within the scope of the Ministry of Equality, Health and Social Policies.
• Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation Data).
• Decree 49/2017, of 21 March, establishing the Andalusian Network of Transfusion Medicine, Tissues and Cells, and regulating its structure and operation.
• Organic Law 3/2018, of 5 December on Personal Data Protection and Guarantee of Digital Rights.

Informative dossiers

• Easy-to-read diptych of the Biobank of the Public Health System of Andalusia
• Easy-to-read diptych of the Andalusian Registry of Donors of Samples for Biomedical Research
• Comic from the Andalusian Registry of Sample Donors for Biomedical Research
• Leaflet of the National Bank of Cell Lines
• Diptych of the Biobank of the Public Health System of Andalusia (Spanish - English)
• Biobanks and Biomodels ISCIII Platform Diptych
• Diptych of the Andalusian Registry of Sample Donors for Biomedical Research (Spanish - English)
• SSPA Biobank Research Area Services Catalogue (Spanish - English)
• Information dossier on the collection, processing, storage, distribution and registration of COVID-19 biological samples

Leads

• Best Practices: Recommendations for repositories. Fifth Edition. (2023)
• Documentation Guide and Application to the Committees that make up the Network of Research Ethics Committees in Andalusia. (2023)
• Guide to Management of Human Biological Samples and Associated Data and Services of the Research Area of the Biobank of the Public Health System of Andalusia (2022)
• Guide for the Management of the authorization procedure of research projects in which biological samples of an embryonic nature and other similar cells are used. (2022)
• Code of Good Practices applicable to Biomedical Research Biobanks in Spain
• ISBER Good Practice Guide: Recommendations for Biobanks (2018)
• NCI Best Practices for Biospecimen Resources Guide (2016)