The INCLIVA Biobank is a public-non-profit-making biological sample and data repository constituted with the main objective of facilitating, promoting and developing scientific research, providing high quality samples and data to be used in the field of biomedical research.
The INCLIVA Biobank’s equipment includes:
• Deep freezers in -80 °C (-112 °F), with base of CO2 and visual, acoustic and remote alarm system.
• COOLSAFE 110 (SCANVAC) freezing system for the immediate cryopreservation of biological samples in -110 °C (-166 °F).
• Automated systems of nucleic acid extraction: QIAGEN’s QIAcube and CHEMAGEN’s Chemagic MSM I.
• Wireless computer system for data registration, and for remote and telephonic management of alarms.
• Computer systems of associated samples and data management.
INCLIVA Biobank comprises biological samples from the following clinical areas:
• Immunological diseases
• Reproductive medicine
The INCLIVA Biobank obtained the authorization for its constitution and running on May 30 th 2013 (dossier code: BI/08/2012) by the Conselleria de Sanitat, Valencian Government, according to the valid legislation (Ley 14/2007, Real Decreto 1716/2011, and Decreto 143/2008).
The INCLIVA Biobank was registered in 2013 in both the Valencian Biobank Register and the ISCIII National Biobank Register (Ref. B.0000768). Its datafile is also registered in the Spanish Agency for data protection (code: 2111521690). INCLIVA Biobank is part of the Valencian Biobanking Network and the Spanish National Biobank Network (PT13/0010/0004).
INCLIVA Biobank works following standardized procedures and has implemented and maintains a Quality Management System, certified by IQNet and AENOR, which fulfills the requirements of the standard ISO 9001:2008 for the following field of activities: reception, processing, storage, and supply of human biological materials in the context of biobanking. (Registration Number: ES-0431/2015_2015-07-16). Thus, te traceability of the material and data associated is ensured.
• Mass of normal and pathological biological samples, collected and kept in optimal conditions, to be used in the field of biomedical research.
• Accessibility to biological samples for research purposes.
• Support in the incorporation of new techniques and new markers to diagnosis, prognosis, treatment, and patient monitoring.
• Collaborative networks with other biobanks that house samples similar to the ones of this biobank.
To guarantee the respect for the basic rights and freedoms, the protection of dignity and identity within the framework of the ethical standards and the effective legislation, the biobank inform consent must be obtained for all voluntary donors of biological material and data. The biobank inform consent form has been authorized by the Conselleria de Sanitat, Valencian Government.
All transfer of samples and data from the biobank to a specific research must be done following the signing of a specific Material Transfer Agreement.
According to Spanish regulation, the inform consent form of a specific research must specify the final destination of the samples and data once the research has finished, with the options being:
- Destruction of the samples and data
- Inclusion in a collection registered in the ISCIII Health Institute
- Inclusion in a biobank, also registered in the ISCIII National Biobank Register. In this case, donors must sign also the biobank inform consent, authorizing the deposit of samples and data in the biobank for future biomedical studies, scientifically and ethically authorized, upon request. Samples and data from the biobank will be stored until the end of stocks if there is no revocation of this consent.