The Instituto Valenciano de Oncología Foundation's biobank obtains ENAC accreditation and becomes the first accredited biobank in Europe
The Instituto Valenciano de Oncología Foundation (IVO) biobank has recently obtained ENAC's accreditation becoming the first biobank accredited according to the UNE-EN ISO 20387 standard, not only in Spain, but also in Europe, according to information provided to IVO from the European Research Infrastructure for Biobanking and Biomolecular Resources (BBMRI-ERIC). This biobank serves researchers in the oncology field, mainly from IVO itself, but also from other centres through the Valencian Biobanking Network and the Spanish biobanking network (ISCIII Platform of Biobanks and Biomodels).
The accredited activity includes the acquisition, preparation, preservation, storage, quality control and distribution of blood, tumor tissues and their derivatives, as well as the data associated with these biological materials.
The importance of this accreditation lies in the relevant role that biobanks play in the research field, as they are responsible for providing biological materials and their associated data to researchers. In the biomedical research field, the authorization and operation of Spanish biobanks is regulated by Royal Decree 1716/2011. However, compliance with the UNE-EN ISO 20387 standard provides greater guarantees, since it is the tool that enables biobanks to demonstrate their impartiality and competence when providing biological materials and their associated data, guaranteeing their quality and compliance with the requirements established by each researcher so that they can use them in the research projects they carry out.
José Antonio López-Guerrero, head of the IVO’s Molecular Biology laboratory service and the Biobank’s scientific director, explains these and other guarantees of ENAC accreditation in the following interview.
What role do biobanks play in the medical research field?
Biobanks represent a fundamental tool in biomedical research, and today, they constitute the main source of biological resources to guarantee reproducible and quality research. With Law 14/2007 on biomedical research primarily, and then with RD 1716/2011, which establishes the basic requirements for biobanks' authorization and operation for biomedical research purposes, a regulatory framework is defined that conditions biomedical research and access to biological resources to carry out these investigations. This regulatory framework positions biobanks as technical units specialized in collecting, preserving, and distributing biological samples and associated data for use in biomedical research projects. As such units, for their operation biobanks require a defined organization, an express authorization by the competent body in the health field and have demonstrated that it has implemented a quality management system.
In short, the biobank acts as a professionalized and guaranteed unit for providing biological resources and data associated with biomedical research projects.
What guarantee does the biobank accreditation give the researcher, the healthcare professional and, ultimately, the patient?
Biobank accreditation in accordance with the ISO 20387 standard is the guarantee that the biobank has competent personnel, with the appropriate means and resources, and with quality biological products, which will enable the researcher to carry out their projects fully guaranteed.
Therefore, the researcher is offered quality biological resources and associated data so that they can carry out their experiments fully guaranteed.
The health professional, who is also a researcher, is offered resources that will make it easier to collect and preserve biological resources following standard work procedures that are continuously assessed to guarantee their quality.
Lastly, patients have transparent guarantees that their donations are used properly in terms of biological samples and associated data. Through the biobank, the patient can in some way participate, with their donations, in advances of biomedical research that, many times, are associated with the pathologies that these same patients suffer.
Do you consider the guarantees provided by accreditation to be important in a field as relevant as oncology?
From my point of view, the guarantee provided by accreditation is key in the oncology field.
The advances occurring over the last decade in precision medicine and in new biomarker identification have shown that, to be successful, it is not only important to have state-of-the-art technology, but also to have adequate bioresources from which results are obtained with a proven level of evidence.
In the clinical trial field, for example, obtaining biological samples and controlling pre-analytical processes can condition the success of a drug, therefore, an accreditation such as ISO 20387 guarantees that the accredited biobank complies with the competence and quality standards required to carry out research of excellence.
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