The biobank is an innovative UPO tool for research, grounding on an inclusive advanced model of the scientific community in which citizens, researchers, and institutions actively participate.
The AGING Project will use the UPO biobank for the “Novara Cohort Study,” a study aiming to investigate the aging processes in the population of the Novara area, to identify lifestyles leading to healthy aging and risk factors associated with age-related diseases.
By providing blood samples, liquids, tissues, and associated clinical data, Each citizen can contribute and be an integral part of the project, becoming an active player in the scientific process and biomedical research on aging.
At the same time, as the donation of the biological material, each donor fills questionnaires about health status and lifestyle.
The biological samples and data collected will be deposited in the UPO biobank and will be made available to researchers to study the molecular mechanisms of aging and related diseases, such as neurodegenerative, cardiovascular, metabolic, and neoplastic diseases.
The processing of data will be carried out in compliance with the requirements of Regulation EU/679/2016, in a protected and safeguarded mode through encryption systems and passwords to prevent reading by those who have not been formally authorized in advance by the data controller. At any time, the donor may access the information from the research project and/or request the destruction of the biological sample.
FAQ – Frequently Asked Question
What is a biobank?
The biobank is a non-profit service unit which, in full respect of the rights of those involved, guarantees and manages the systematic collection, storage, and distribution, according to proven quality standards, of human biological samples and related information, for biomedical purposes (research, diagnosis, prevention or therapy).
The biobank performs a public, third-party service as a guarantee of the process and purpose of the collection of biological material and information to all stakeholders and society.
How does biobank work?
In the biobank’s spaces, starting from the entrance, everything is monitored down to the last detail. The facilities are equipped with electronic access control and an alarm system that signals any malfunctioning. At the same time, the management of samples and data is performed through software that guarantees traceability and anonymity.
Depending on the type, samples can be cryopreserved in freezers that reach a temperature of -80°C or in special containers, equipped with a liquid nitrogen circuit that brings the temperature to -198°C. Cryopreservation is required to preserve unaltered biological material for long periods.
Are there different types of biobank?
Biobanks are distinguished in various ways, two of which are fundamental: by the type of biological material collected and by the purpose for which they are collected.
Biobanks are diversified because they can collect different types of biological material (cell lines, tissues, cells, biological fluids, DNA, umbilical cords, organs, male gametes, and eggs, etc.) from healthy and/or sick individuals.
Depending on the purpose, it is possible to distinguish biobanks that are primarily disease-oriented (oncological, genetic, multi-specialist) from biobanks primarily aimed at population studies that collect biological material belonging to population groups with particular characteristics.
What is the role of a biobank in scientific research?
The biobank is a precious resource that makes available to researchers several biological samples and epidemiological, clinical, and research data until a few years ago unthinkable. The biomedical research related to a biobank has as its primary goals:
- to improve knowledge of disease risk factors to prevent the onset of disease.
- to identify biomarkers for early diagnosis
- to develop precision medicine and personalized therapy
Why participate in a biobank?
The biobank has a scientific impact the more it rests on solid collaboration between the population, re-searchers, and institutions. Each participant plays an irreplaceable role: the citizen is the activator and re-ceiver of the process itself, the biobank preserves and protects it, the clinic informs and collects the sam-ple, the researcher discovers new opportunities.
Donors must be informed about the activities of the biobank, the orientation of the research and the use of the results.
What is the role of the biobank in society?
The biobank also becomes a tool for the active involvement of people in the public debate about science purposes.
Participating in a biobank helps us to become aware of the profound scientific and social revolution in progress, determined by the genetic and biomolecular turning point in research and care, which requires a new model of citizenship, ethics, and construction of scientific knowledge, participatory, inclusive and empowering.
The freedom and interests of science must be balanced with the necessary protection of the human being: informed consent and the rights of the donor.
The donor is an active part of the process that enables the activity of a biobank: without its biological matter and its clinical history the biobank would not exist.
In order to protect the dignity and respect of the individual, its inclusion in research processes can only take place if the subject expresses a free and informed consent and if there is the authorization of an in-dependent Ethics Committee and the guarantee.
The act of consent through which the donor leaves his/her biological material is a fundamental require-ment for the collection, conservation, and use of his/her biological material and must be characterized as a free, conscious and participatory act.
In terms of good practice, since informed consent must cover the entire process to which a sample is submitted, the information offered must, accordingly: i) explain the phases of collection, conservation, use and transfer to other researchers or institutions, other than the proposer; ii) explicit that it is possible to return information to the donor on the results of the research; (iii) give indications on the possible consequences for the donor or members of the donor’s family of the results of the molecular tests, (iv) explain the possibility of anonymizing the samples with a code, (v) specify the measures taken for the protection of personal data, (vi) indicate the name and contact details of the person in charge of the bio-bank, i.e. the processes of data protection and circulation of anonymized samples, (vii) state the possibili-ty for the donor to withdraw his or her consent at any time and request the destruction of his or her per-sonal data and samples; (viii) specify the fate of the samples in the event of revocation or closure of the biobank; (ix) set out any commercial prospects for the research.
The link between the donor and the biobank does not end with the donation but grows the more the re-search is developed. Therefore, the donor continues to have the right to data protection, to being infor-med about new research fields or results, to revoke his/her informed consent at any time.
Main legislative references on the protection of personal data
Following the entry into force of the General European Regulation on the protection of personal data and privacy, (European Regulation 2016/679 – General Data Protection Regulation – GDPR), the Legislative Decree no. 101 of 10 August 2018 (in force since 19 September 2018), which adapts the Personal Data Protection Code (Legislative Decree no. 196 of 30 June 2003) to the provisions of the EU Regulation, was approved. The articles of the Code thus updated, of interest for research, are art. 110 (medical, biomedical and epidemiological research) and art. 110 bis (further processing by third parties of personal data for scientific research or statistical purposes),
On 5 June 2019, the Guarantor for the protection of personal data, therefore, approved the “Measure identifying the provisions relating to the processing of personal data carried out for the purposes of scientific research and the processing of genetic data, pursuant to Article 21, paragraph 1 of Legislative Decree no. 101 of 10 August 2018 (Measure no. 146).