Ethical and Legal Framework
Legal framework
The BTN-INCYL is a public biobank located at the headquarters of the Institute of Neurosciences of Castile and León, University of Salamanca, and serves the entire region of Castile and León.
Since 2007, the donation of samples to biobanks has been regulated by the Biomedical Research Act (14/2007) and the Biobanks Royal Decree (1716/2011), which implements it. This legal framework guarantees donor rights, including the protection of personal data, and establishes that the transfer of samples for research must be free of charge and must ensure the proper use of the donated material [Organic Law 3/2018, of December 5, on Personal Data Protection and Guarantee of Digital Rights (LOPD-GDD)].
In compliance with the aforementioned regulations, the activities of the BTN-INCYL are overseen by external committees: a Scientific Committee and a Research Ethics Committee.
The BTN-INCYL follows, in the planning and development of its activities, the Guidelines and Recommendations on Good Practice issued by national and international bodies.
The activities of the BTN-INCYL are carried out at all times in accordance with Standard Operating Procedures and international quality standards.
Accreditation and registration
In accordance with current regulations, the BTN-INCYL is accredited as a human biological sample biobank by the Regional Ministry of Health of the Regional Government of Castile and León as of 21 June 2013, and is registered in the National Biobanks Registry of the Carlos III Health Institute under number 1262.
Sicentific Comitee
The External Scientific Committee of the Tissue Bank of the CIEN Foundation in Madrid (BT-CIEN) serves as the scientific committee of the BTN-INCYL and is composed of renowned neuroscience researchers.
The functions of the Scientific Committee are:
To carry out the scientific evaluation of requests for the transfer of samples and associated data submitted to the BTN-INCYL. In cases where the Scientific Committee issues an unfavourable report, such a decision shall be binding.- To advise the Scientific Director on the adequacy of the procedures established to ensure the quality, safety, and traceability of the stored data and samples, as well as on the procedures associated with the operation of the BTN-INCYL, from a scientific perspective.
- To advise the Scientific Director on the scientific aspects of the BTN-INCYL Good Practice document.
- To assist the Scientific Director on any other matters that he/she may submit for consideration
Good Practice Documentation
Good Practice Documents and Guidelines have a different level of requirement and enforceability compared to Quality Standards. The decision to adopt one or more management standards is voluntary; however, once that decision has been made, compliance with the various requirements of the standard becomes mandatory in order to achieve or maintain certification/accreditation. Unlike management standards, which are generic and applicable to a wide range of organisations, these recommendation documents have been specifically developed for biobank management. For this reason, they are directly applicable to the most specific aspects of a biobank’s organisation.
A Good Practice is a management concept that holds that there is a technique, method, process, or activity that is more effective than any other for achieving a given result.
A Guideline is any document intended to guide specific processes in accordance with an established routine.
Documents and Guidelines used as reference for the management of the BTN-INCYL.
ISBER Best Practices for Repositories: Acquisition, Storage, Retrieval and Distribution of Biological Materials for Research (ISBER Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research). Cell Preservation Technology 6(1), 3–58, 2008.
This is a Good Practice document aimed at biobank managers and staff, covering both management and technical aspects, with a detailed approach to practical issues such as infrastructure, equipment, safety, and staff training. It is applicable to both human and non-human sample biobanks and focuses on the daily management of a biobank. ISBER has developed a self-assessment tool that allows any organisation to determine the extent to which it complies with the Good Practices published in this document.- National Cancer Institute (NCI) Best Practices for Biospecimen Resources (2007).
This document was developed specifically for biobanks supported by the NCI that store human biological samples. It focuses on the management, quality, and protection of data associated with biological material. It also includes a specific section on intellectual property. - OECD Best Practice Guidelines for Biological Resource Centres (2007) and OECD Guidelines on Human Biobanks and Genetic Research Databases (2009).
The OECD has developed guidelines for both human and microbiological biobanks. These guidelines are oriented towards the certification of biobanks in accordance with national and/or international standards. Their development has been influenced by microbial Biological Resource Centres, and therefore one of their main areas of focus is the authentication of biological material.
Standardised Model for Biobanks, Marble Arch Working Group on International Biobanking. Compiled Standard Model for Biobanks (2008), cited as MECB-07.
The Marble Arch Working Group has developed and published Good Practice Guidelines for biobanks, based on various previous guidelines and using ISO 17025 and ISO 34 as references. These guidelines are intended to serve as international standards for the certification and accreditation of biobanks in different countries.- International Society for Biological and Environmental Repositories.
- ISBER.org.
- Biospecimens.cancer.gov.
- OECD.org.