Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

Abstract

In 2017, Polish Biobanking Network was established in Poland, within BBMRI.pl project titled “Organization of Polish Biobanking Network within the Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC” as a strategic scientific infrastructure concept. One of the key elements of the project was the verification of the current status of QMS in the Polish biobanking institutions and the implementation of common solutions. The main goal was to indicate the current QMS level and determine the starting points for QMS development for each biobank of the Polish Biobanking Network (PBN). Within 3 years, 35 audit visits were performed. The current status and the level of QMS implementation in each biobank were assessed. Five hundred and seventy recommendations were prepared. The data was analyzed using Fischer Exact test to determine whether or not a significant association was observed. Three areas of analysis were covered: (1) BBMRI.pl status, (2) QMS implementation level and (3) private/public party, respectively. The results were discussed within 15 areas. Concluding remarks showed that some differences were observed in the case of subgroups analysis. There is convergence in QMS within the biobanks where Tissue Banks are located. Moreover, some discrepancies between the QMS implementation level in BBMRI.pl Consortium biobanks and PBN biobanks are observed. Nevertheless, the consortium members are obliged to prepare other biobanks willing to enter the PBN as Members/Observers or which already are in the PBN, so that they can meet the requirements of the quality management system that will enable efficient management of biobanking processes in these units. That is why some actions within BBMRI.pl projects are organized to help the whole biobanking community in Poland implement the harmonized solution.

To donate or not to donate? Future healthcare professionals’ opinions on biobanking of human biological material for research purposes

“…Although Poland has been a part of the European biobanking research infrastructure for almost a decade [ 25 – 27 ] and many Polish biobanks are highly specialised units, many are yet to implement a system of quality control and lack specific guidelines on methods of quality assurance for biobanking processes [ 28 ] or a system of proper ethical, legal and social issues (ELSI) to ensure the safety and privacy of donors and their data [ 55 – 57 ]. At the same time, although new Quality Management System has been created recently [ 15 , 57 ], still, there remain no legal regulations unifying the activities of biobanks and biomedical research in Poland. Biobank research therefore provokes a heated debate over such issues as informed consent, data protection and sharing, and profit-making, which might discourage possible donors [ 58 – 61 ].…”

“…However, this should not surprise since according to the General Data Protection Regulation (GDPR) that have been implemented in Poland by the Personal Data Protection Act of May 2018 all personal data have to be protected, and the Polish biobanks guidelines of good practices and data protection follow international and European regulations and recommendations created by international organizations regarding that matter (i.e. BBMRI-ERIC and ISBER) [ 15 , 26 , 57 ].…”

“…Simultaneously, it is crucial to recognize that comprehensive education in biobanking should extend beyond physicians and nurses to encompass all relevant specialties necessary in biobanking. This research highlights the importance of educational programs that should cover the latest advancements in biotechnology, including genetic engineering, genome sequencing techniques, AI-driven process automation, data analytics, and robotics, but also incorporate a deep understanding of international and national ethical, legal, and societal standards [ 15 , 57 , 70 ]. By integrating these diverse elements into educational curricula, HCPs can assume a more proactive role in advocating for research biobank donations [ 6 , 7 ].…”

“…At the same time, while they should be trained about the concept, purposes, and operational procedures of biobanks, the future of biobanking also requires the development of new education courses, for both medical students and medical and health experts, that should include not only programs on the latest biotechnological advances, but also international and national ethical, legal and societal standards for biobank research, including informed consent, level of participation, data protection and sharing, the return of research results and the profit-making. Finally, since the biobanking in Poland is still in an early stage of development and there is currently no uniform regulatory system that applies to research biobanks, there is a urgent need to implement standards that would facilitate the functioning of biobanks in the county [ 15 , 28 , 29 , 57 ]. Additionally, standardised guidelines for in all Europe countries are also recommended, that would facilitate the sharing of biosamples and information and cooperation among researchers across different countries and the protection of donors’ rights.…”

Attitudes of oncology patients’ towards biospecimen donation for biobank research

“…This is important, since biobank research raises important ethical, legal and social (ELSI) challenges related to, inter alia patients’ autonomy, data protection and confidentiality, control of information and sharing of biosamples, commercialization and profit sharing, which may affect people’s trust towards biomedical research and their willingness to donate 1 to biobanks [ 15 – 20 ]. For that reason, the PBN plays a crucial role in the development and implementation of standards for procedures and management formulated according to the guidelines created by the International Society for Biological and Environmental Repositories (ISBER) which is a key organization in the activity and innovation for biobanking and the harmonization of scientific, technical, ethical and legal issues [ 21 – 23 ]. Consequently, although still Poland still has no legal regulations on biobanks or specific biobank act, in 2021 following international and European regulations and recommendations created by BBMRI-ERIC and ISBER quality standards for Polish biobanks have been created.…”