WHO CAN BE A DONOR?
Every citizen of the Slovak Republic can be a donor of biological material. The donor voluntarily agrees to provide his own sample and related data for their subsequent storage in the premises of the Biobank in Martin and their further use for scientific and research purposes. Such a sample can be various body fluids or tissues and nucleic acids subsequently obtained from them.
WHY DONATE BIOLOGICAL MATERIAL?
By systematic and continuous collecting biological material, the Biobank obtains high-quality and numerous sets of samples that can be used very flexibly for biomedical research. Thus, scientists and doctors do not have to collect samples for years to obtain a set of suitable size. Likewise, in the case of new technologies or medicines, scientific studies can be carried out immediately, which accelerates research processes and acquired knowledge and data.
The information obtained in this way contributes to a more detailed knowledge of the causes and pathophysiology of diseases, as well as to the development and validation of new diagnostic methods and modern therapy. Research results are also used in personalized medicine, where therapy is individually adapted to each patient. Because patients can respond to standard oncology treatments in different ways, it is important to find the most effective therapy for each individual. This requires detailed and precise research, in which data is often obtained from medical and biological databases.
RIGHTS OF THE SAMPLE DONOR
Before the sample collection, the donor is provided with all the necessary information, such as:
- the importance of storing samples in the Biobank, the focus of the Biobank,
- type and amount of sample taken,
- risks associated with the collection and storage of samples and associated data,
- ensuring data protection,
- providing a sample for scientific purposes without personal data,
- contact person in a case of withdrawal of the consent.
Subsequently, the donor will receive a form – the Informed Consent, where he/she will indicate and sign the type of consent granted for the collection, storage, and subsequent use of the sample. In the event that the results of the research could have a fundamental impact on the health status of the donor (if, for example, a hereditary predisposition to oncological, metabolic, or other serious diseases is detected), or could be used for the purpose of modifying and improving the treatment applied so far, the donor may be informed about these results without delay, as long as this possibility of retrospective identification and contact was mentioned in the Informed Consent. The donor has the right to withdraw his/her consent to the storage and use of samples and data at any time, even without giving a reason. Withdrawal of the consent shall not affect the state of health of the donor or his/her treatment and provision of health care. Samples and data stored until then will be subsequently removed according to the Biobank protocols.
QUALITY OF SERVICES PROVIDED BY THE BIOBANK
To ensure continuous quality according to the international standards, the Biobank has developed specific procedures and documents:
- SOP – standard operating protocols for collection, transport, processing, storage, release, or disposal of samples, separately for each type of sample (for example, blood, urine, plasma, fresh tissue, and others),
- registration of samples and accompanying data, ensuring the protection of personal data, pseudonymization, and anonymization,
- quality management ensuring continuous analysis and quality control of processes in the biobank, implementation of the criteria of the international European infrastructure for biobanking: BBMRI – ERIC,
- harmonization of operating procedures,
- ensuring continuous education in biobanking quality issues,
- preparation for accreditation and certification according to ISO 20387 and other related documents.
LEGISLATION
The international standard ISO 20387: 2018 Biotechnology – Biobanking – General requirements for biobanking represents the basic document for high-quality biobanking procedures and institutional support. In addition, biobanking falls under biomedical research activities within the framework of Act No. 576/2004 Coll. and Act NR SR 578/2004 Coll., the amendment of which is also being prepared as a part of this project under the auspices of the Ministry of Health of the Slovak Republic.
ISO 20387: 2018
The international standard ISO 20387 sets detailed and precise requirements for biological material and data quality, which demonstrate the competence of the organization in the field of proper handling of biological material, anonymization of patient data, and long-term archiving of biological samples.
ISO 20387 accreditation also implies an independent assessment of the Biobank, which includes a review of the quality management system, qualifications and competence of personnel, biological material handling, storage environment, equipment, and data to ensure continuous compliance and maintain the highest standards of biobanking quality. Biobank organizations accredited in this way are regularly reassessed to ensure continuous maintenance of technical knowledge and other competencies. The Biobank for Cancer and Rare Diseases implements all necessary measures to harmonize with this standard with the aim of obtaining accreditation for biobanking.
ISO 9001: 2015
The Biobank in Martin, as a part of Comenius University in Bratislava, the Jessenius Faculty of Medicine in Martin, also meets the international standard ISO 9001: 2015, which specifies the requirements for the quality management system. Thus, the Biobank must regularly demonstrate its ability to consistently provide services that meet the customer’s requirements and applicable legal and regulatory requirements, and further aims to increase customer satisfaction through the effective application of the biobanking system, including other processes necessary to improve the operation of the system, ensuring compliance with customers and the vision building a stable, modern and prosperous institution.
PERSONAL DATA PROTECTION
Security of personal data of sample donors
All personal data of sample donors are anonymized and inaccessible to third parties. The rights of donors and the interests of interested parties are protected by generally binding legal regulations of the Slovak Republic (SR) and the European Union (EU). The use of a donated sample for biomedical research in no way violates the privacy of donors or the confidentiality of their health information.
At the same time, the employees of the Biobank for Cancer and Rare Diseases are bound by their signature to confidentiality and declare that they will not use the obtained data and information for other than scientific purposes and will not identify the project participants in any way.
The use of a unique code identifier
The name and other identification data of the donor are automatically replaced by a unique code identifier, on the basis of which it is not possible to determine the identity of the donor. The decryption key to the identifier is kept separately and accessible only to selected personnel in the event that several conditions are met (for example, the donor’s request for feedback). In this way, a multi-step degree of protection is achieved.
Withdrawal from participation in the project
Every donor has the right to withdraw their consent to the storage of samples and their use for biomedical research at any time, even without giving specific reasons. In such case, his/her data and samples shall be removed and disposed of according to international standards and standard work procedures. For the successful progress and fulfilment of the goals of the project, it is most appropriate for the participating sample donors to be a part of it as long as possible, as any change in their health status can bring valuable data for research.
Biobank for Cancer and Rare Diseases
Jessenius Faculty of Medicine in Martin
Comenius University in Bratislava
- L. Novomeského 11947 / 7B 036 01 Martin
