Organization of BBMRI.pl: The Polish Biobanking Network

Abstract

In Poland storage of human biological samples takes place at most universities and scientific institutions conducting research projects in the field of biomedicine. The First International Biobanking Conference organized by the Ministry of Science and Higher Education in 2014 shed a light on the situation of Polish biobanking infrastructures. The country has around 40 large biorepositories, which store unique biological material such as whole brains, muscle fibers from patients with rare diseases, as well as thousands of samples from patients with lifestyle diseases. There are only two population-based biobanks working locally and several disease-oriented biobanks specializing mainly in oncological diseases. Consortium BBMRI.pl created plans for establishing a Polish Network of Biobanks, with national node which meets standards for biobanks and cooperation to guarantee development of biomedical sciences and international collaboration between Poland and other countries. The Polish network will enhance research activities, due to better visibility of samples and data that are stored in the national biobanking catalogue. However, it requires more than a comprehensive understanding of all benefits. The list of examples of benefits can be presented as follows: (i) a reduction of the duration and cost of clinical trials and subsequent time to market for anticancer drugs; (ii) more precise patient diagnosis and the associated impact on treatment and lower healthcare costs for providers, individuals, and the nation; (iii) improvements in research experiment time frames and data efficiencies; (iv) convergence to an industry standards for biospecimen quality; (v) optimization of capital infrastructure and IT technology.

Introduction

In 2009, Time Magazine described biobanks as “One of the 10 Ideas Changing the World Right Now.”¹ In many articles, discussions about biobanks are presented as powerful and indispensable sources for scientific research. Samples and data deposition have become an increasing trend in the world. The collection of biological samples by biobanks, which is critical for biomedical research, plays a prominent role in the area of biomarkers and “personalized medicine” development. In 2013, more than 1500 biobanks were estimated to be in operation globally. The highest activity is attributed to Europe and North America.² The importance of the existence of biobanks in both nonprofit and commercial sectors across the market is indisputable. Moreover, in the nonprofit sector, biobanks are located in government research laboratories, academia, nonprofit research institutes, and public hospitals.

In countries where deposition of biospecimens is highly developed, cooperative entities are formed, such as the Southwest Oncology Group (SWOG), Eastern Cooperative Oncology Group (ECOG), and Gynecologic Oncology Group (GOG) in the United States. There are also nonprofit charitable, community-based organizations such as the Juvenile Diabetes Research Foundation (JDRF), Accelerated Cure Project for Multiple Sclerosis, and American Cancer Society (ACS). The commercial sector of biobanks is mainly concentrated with the service provider function represented by private research laboratories, clinical research organizations, and also as pharmaceutical and biotechnological sample management facilities.²

In Europe, the role of biobanks in the development of biomedical research was recognized many years ago, therefore, European Union countries put in a significant effort to develop this type of infrastructure. One of the most important steps was establishment of the pan-European organization BBMRI-ERIC (Biobanking and Biomolecular Resources Research Infrastructure–European Research Infrastructure Consortium). According to the ESFRI Roadmap (http://cordis.europa.eu/esfri/roadmap.htm), the BBMRI-ERIC was established to ensure the development of, and controlled access to, biobanks' resources for academic units and industry. BBMRI-ERIC is one of the largest health-related ERIC-type organizations in Europe with 18 countries and one international organization (as of May 2016).

In Poland, storage of human biological samples for research purposes takes place at every medical university in the country, and in most scientific institutions conducting research projects in the field of biomedicine. In 2010, some of the biggest biobanks were already registered³ as associate members of the BBMRI preparatory project,⁴ however, they never collaborated as a network of biobanks, which started using a common solution for the samples and data collection. This puts Poland in an exceptionally difficult situation, especially when most of the biobanks from EU countries already started cooperation on the national and international level. The first international biobanking conference organized by the Ministry of Science and Higher Education in 2014 shed light on the real situation of Polish biobanking infrastructures.

Analysis of questionnaires distributed during the meeting showed that the country has around 40 large biorepositories, some of them storing unique biological samples such as whole brains and muscle fiber from patients with rare diseases. There are only two population-based biobanks working locally and several disease-oriented biobanks specializing mainly in oncological diseases. All the units work according to individual operating procedures, and medical data are collected using in-house systems as well as commercial solutions, however without any standardization such as MIABIS 2.0.^5,6

Each member state of the European Union may apply for participation in the BBMRI-ERIC organization at two levels: as a member or as an observer. Observer status, which was applied for by Poland in 2013, is valid for a maximum period of 3 years. As an observer, Poland participates (without voting rights) in the Assembly of Members and may participate in certain activities of the BBMRI-ERIC determined by the Assembly Members. Participation as a member of the organization requires that Poland creates a network of biobanks, setting standards of biobanking, developing common quality management systems, creating unified IT solutions, and to establish biobanks according to ethical and legal norms similar to other EU partners of BBMRI-ERIC and apply for it.

Biobanks, like all other biomedical resources, such as laboratories, to guarantee a high quality of research, have to work in accordance with standard operating procedures (SOPs). These procedures describe each step of the research process applicable to most research and service laboratories. In the case of biobanks it is much more difficult to introduce SOPs, as procedures introduced to guarantee a high quality of product must provide the quality of samples required in research in the next several years. The procedures must also provide the best way of collecting demographic and medical information about donors of biological material. It is worth mentioning that the way information is collected significantly influences statistical analysis of medical and personal characteristics associated with particular samples of biological material that will be performed in the future. All these aspects can affect the quality of produced research data. Therefore, cooperation in multicenter studies requires special caution at the stage of creating databases for statistical analysis. One of the main objectives of BBMRI-ERIC is to standardize procedures of working with biological material and data associated with it, to exploit, as effectively as possible, an opportunity of multicenter cooperation, which is guaranteed by this organization.

Materials

The main task of our project is to create a plan for establishing a Polish Network of Biobanks, with a BBMRI.pl national node, which meets standards for biobanks and cooperation, to guarantee development of biomedical sciences, and international collaboration between Poland and other countries. Several factors have made this project important, such as the size of the Polish population and small number of projects related to population genetics, the number of genetic variants conditioned by historical factors that have not been characterized yet, the number of people suffering lifestyle diseases, as well as the fact that personalized medicine, which soon will become a standard approach in the patient healthcare, cannot develop without biobanking.

In our opinion, it is exceptionally important to fund a network of biobanks, which will speed up research on human samples as described above, considering that Poland has a rapidly growing number of medical research centers. Hundreds of thousands of human samples are stored at Polish biobanks and biorepositories, and do not have a chance to be used for scientific purposes because there is no cooperation between local and foreign partners. BBMRI.pl Consortium members, such as Wrocław Research Center EIT+ (WRC EIT+),⁷ Medical University of Gdańsk (MUG),⁸ Medical University of Warsaw (MUW),⁹ University of Lodz (UL),^10,11 Medical University of Lublin (MUL),¹² Wroclaw Medical University (WMU),¹³ and the Regional Science and Technology Center (RS-TC),^14,15 also are aware that all steps covered in our project will help to sort out issues related to sample and data collection, access to samples for national and international projects, sample donors' rights and the legal transportation of samples between Poland and other countries.

Methods

This proposal created by consortium members resulted from previous cooperation with BBMRI-ERIC and several visits to our European partners (Austria, Estonia, and France). BBMRI-ERIC, as one of the biggest European ERICs, offers their partners number of services supporting their local actions, a platform for cooperation with pharmaceutical industry, and a common application for funding, for example within Horizon 2020. The consortium was appointed to implement the project consisting of the major biobanking centers in Poland and academic institutions. The consortium has developed six main milestones (MS), which are necessary to start a cooperation with foreign partners, and become a full Member of the European Network BBMRI-ERIC.

MS1: Establishing a network of Polish Biobanks (carried out by MUW)

Creation of a network for Polish Biobanks is essential to start multicenter projects and cooperation between national and international partners. This is crucial for population health research and projects on rare diseases. The first step in accomplishing this task will be to obtain information about Polish institutions dealing with the broader biobanking or storage of biological material and data collection. On the basis of the collected information, the biobanking institution database will be created. We will address our invitation to join Polish network to all medical universities, departments of biological sciences, clinical entities, units of the Polish Academy of Sciences, research institutes, separate biobanks, pharmaceutical companies, and public and private cell banks. The criteria for joining the database will be broad, so many potential biobanks will be recognized and taken into account in subsequent stages of the project. All institutions joining the biobanking network will work with researchers implementing this MS. The aim is to define the characteristics of each biobank, for example: the specific types of biological samples that will be banked in the institutions, for example, blood, tissue, DNA, type of biobank/repository etc. At this stage we will also characterize the way samples are collected, for example, whether the material is collected directly by the biobank or from clinical sites, describe transportation conditions, and time from sample collection to sample preservation. Moreover, we will characterize what type of information related to the lifestyle and clinical data was collected by each biobank, what kind of consent form has been used, and the scope of cooperation with units other than biobanks that also collect biological material. Cooperation in the area of ethics and law will result in the development of a common model of informed consent for the patient/donor, to conduct research on the deposited biological material. This will be also linked to other milestones such as MS3 and MS6.

MS2: Coherent IT solutions (carried out by MUG and UL)

A unified information system that supports the functioning of biobanks is a key step for effective cooperation between current and future members of the European and Polish network of biobanks associated with BBMRI.pl. IT solutions enable efficient cooperation, both at the level of logistics, initiating joint ventures to conduct massive population studies, as well as contributing to the promotion of models for conducting common scientific research to the highest standards. The homogeneous version of the BIMS (Biobank Information Management System) and unified data model will provide a high level of communicability and compatibility of stored data, both at the level of a single sample of biological material and complex information (e.g., medical) associated with sample donors. This system will ensure proper management of implementation of major projects, such as obtaining prospective collections, targeted collections of patients with rare genetic diseases, and population-based studies in general, at the organizational as well as detailed level (samples supervision and proper storage of information about donors of the samples). The planned modular structure of the IT system will allow adoption of existing technologies in various biobanking units to meet their specific requirements and could be easily expanded in the future. The system will provide the proper standard of processing data (among others: distributed backup system, hardware-based connection security between nodes) that will be implemented among present and future members of BBMRI.pl. The high security level of used solutions will allow to integrate the System with National Registers to obtain more detailed data.

One of the main system project goals is to provide the highest possible level of protection of processed data. By this we assume protection against unauthorized access from outside as well as from inside; granting access rights by restrictive conditions; protection of the privacy right and personal data protection by implementation of tools that will provide anonymity for donors. Versatile solutions will be designed to efficiently monitor environmental conditions of biological material storage, as well as in laboratories in which the material is processed. An extensive monitoring system will facilitate rapid reaction of the personnel responsible for the biobank, to sustain safety of biological collections in emergency situations (power outage, failure of refrigeration equipment, and other). Poland is already involved in the IT working group of BBMRI-ERIC (as of May 2016).

MS3: Verification of SOPs that exist in Polish biobanking institutions, implementation of common solutions (carried out by WMU)

This MS is crucial for the cooperation with national and international partners to guarantee high quality of data collected and produced on large sets of biological samples. At the initial stage of the project, the consortium partner conducting MS1 (MUW) will establish contact line with major biobanking institutions in Poland. All the efforts made in MS1 will result in verification of the quality management and assurance system (regulations, procedures, instructions, forms, labels, and algorithms). The next step will be to evaluate the guidelines in verified documents and to create a template of standards based on a review of available system documentation. After completion of the phase 2 of evaluation, all the information included in the evaluation sheet will be compared with international legal documents and medical/laboratory standards for biobanking, data confidentiality, and ICT guidelines. In this phase, a template standards uniform for all biobanks will be created. After preparation of the document concerning Quality Standards Guideline for the Polish biobanking sector, the team implementing MS3 will train biobank employees in the field of developed standards (such as preparation of necessary documentation, introducing changes to documents and change monitoring, control of documents, IT solutions and standards etc.). The next step in MS3 implementation will be to develop and publish standards in the form of a bilingual (Polish and English) handbook for biobanks. The manual will contain requirements along with an explanation and hints to using the applicable documents. The last stage of the MS3 will involve audits of biobanking institutions, assessing the state of implementation of the guidelines and postaudit validation after removing nonconformities presented in the audit report. Special attention will be given to the newly adopted and published CEN (European Committee for Standardization, www.cen.eu) norms for preanalytical examinations (Table 1). Poland is already involved in the QM working group of BBMRI-ERIC (as of May 2016).

Table 1.

List of Examples of CEN Technical Specifications Chosen for the Implementation

CEN/technical specification
CEN/TS 16826-1: Specifications for pre-examination processes for snap frozen tissue–Part 1: Isolated RNA
CEN/TS 16826-2: Specifications for pre-examination processes for snap frozen tissue–Part 2: Isolated proteins
CEN/TS 16827-1: Specifications for pre-examination processes for FFPE tissue–Part 1: Isolated RNA
CEN/TS 16827-2: Specifications for pre-examination processes for FFPE tissue–Part 2: Isolated proteins
CEN/TS 16827-3: Specifications for pre-examination processes for FFPE tissue–Part 3: Isolated DNA
CEN/TS 16835-1: Specifications for pre-examination processes for venous whole blood–Part 1: Isolated cellular RNA
CEN/TS 16835-2: Specifications for pre-examination processes for venous whole blood–Part 2: Isolated genomic DNA
CEN/TS 16835-3: Specifications for pre-examination processes for venous whole blood–Part 3: Isolated circulating cell-free DNA from plasma
CEN/TS 16945:2016: Specifications for pre-examination processes for metabolomics in urine, venous blood serum, and plasma

MS4: Creating National Node for population biobanking and supervising activities of the Polish biobanks network, which will organize cooperation between Polish biobanks network and European platform BBMRI-ERIC (carried out by WRC EIT ±)

A National Node is an entity, not necessarily of a legal nature, designated by a BBMRI-ERIC Member, which coordinates national banks of human biological material and combines national action with BBMRI-ERIC European actions (Statutes of BBMRI- ERIC, Article 1.6 and Article 1.8).¹⁶ In the light of the Statutes and the BBMRI preparatory project (2008–2012), the National Node will supervise all activities of the Polish BBMRI.pl network that will include Polish biobanks and biorepositories of human biological material that fulfill particular criteria to join the abovementioned network. One of the main tasks of the National Node facility will be the coordination of educational activity, especially among scientists who plan to start biobanking institutions. The National Node, as a unit of reference, leads a typical biobanking activity in the region and/or the entire country. Access to biological material enables scientific research, biobanking training, and testing and implementation of new technical procedures developed at the European organization BBMRI-ERIC level. It is assumed that it should be a leading institution in biobanking of human biological material in accordance with international legal, technical, and ethical standards. The facility should employ staff who are experienced in biobanking and should regularly conduct courses on legal and ethical norms and technical aspects of biobanking for those wishing to start, or are already running biobanks and biorepositories of human biological material. Therefore, it is necessary to ensure the maintenance of such a unit for the duration of the consortium, since it is one of the key bases for technical activities. Due to the fact that in Poland a vast majority of institutions work in the form of specialized biobanks (biobanks dedicated to collecting biological material from patients suffering from specific diseases), and there is no national biobank, it is proposed in this project to continue population biobanking activities on the basis of the resources that WRC EIT+ has collected so far and of the unit's experience in the recruitment of patients.

The Director of a National Node, nominated by the Government, also called the National Biobanking Coordinator, participates and cares for the recruitment of national centers to international projects, for which BBMRI-ERIC applies. The task of the National Biobanking Coordinator is to participate in the BBMRI-ERIC Management Committee, representing the position of Poland concerning biobanking of human biological material in international forums, participating in BBMRI-ERIC related to strategic decisions of the organization, informing biobanks affiliated at the national organization level about changes in the pan-European network and introducing new changes across the country. The National Biobanking Coordinator participates in, and takes care of, recruitment of national centers to international projects for which the BBMRI-ERIC organization applies. The National Node should supervise implementation of all of the milestones described in the feasibility study of the project, integrate the activities of individual centers to create a coherent organization which BBMRI.pl will constitute, but also should offer help and implement corrective measures in case of an inability to implement individual actions. Staff employed at the National Node, in addition to the typical biobanking activities, also provide administrative support for the activities of the National Biobanking Coordinator and consortium partners.

MS5: The introduction of quality control systems (carried out by MUG and other BBMRI.pl's consortium members)

A quality control (QC) system that is monitoring each step of human sample and data handling is a key step to control all stages of the biobanking unit operation. All steps performed in this MS are strictly related to data obtained in MS1 and MS3. In multiple population/cohort studies, during the cooperation between academic units and pharmaceutical industry, any unit providing samples is asked to prove that all the quality control criteria during biobanking of human samples were fulfilled. The QC system created by the Polish consortium will allow effective cooperation between current and future members of the European and Polish Biobanking Network associated with BBMRI.pl and the pharmaceutical industry. To accomplish this, the quality of the sample and its data described in SOPs have to be determined. A quality assurance system for all stages of sample processing in biobanks has to be implemented. Verification and validation of all technical solutions developed during the BBMRI.pl project will be based on the “prototype collection” of biological material from about 500–1000 people from each center participating in the project. This collection will allow the Network not only to validate implemented solutions, but will enable creation of a cohort of a few thousand Poles, a cornerstone for the Polish National Biobank. All SOPs and IT solutions set up in different biobanks will be evaluated, determination of sample integrity will be performed, and medical data and screening testing for lifestyle diseases (initially we proposed biochemical testing for diabetes and atherosclerosis), in residents of several regions of Poland, will be performed as well. In addition to the validation of developed solutions, the BBMRI.pl consortium will aim to publish an article on health population in certain regions and the entire country, based on the results from the diabetes and arthrosclerosis screening program. It is important to mention that all steps will be discussed regularly with the BBMRI-ERIC Quality Manager, who is in charge of QC systems at the European Level.

MS6: Ethical, legal, and social implication (carried out by MUL)

Development of biobanking for research purposes requires ethical, legal, and societal analysis (ELSI analysis). Some ethical and social studies were done in Poland over recent years^17–19 and the idea of a Polish national biobank was brought into scientific debate.²⁰ The most common problems associated with biobanking include informed consent, ensuring privacy, nondiscrimination (in the field of insurance, work, school), returning results, as well as the ownership status of the samples stored in biobanks and the matter of sharing profits from commercialization of the research results.²¹ The consenting process is a complicated problem as it concerns the consent for future research (the specific aim, place, and researchers are currently unknown), the possibility to reuse the samples for purposes not well defined at the moment of obtaining the material, and using material taken from deceased donors, minors, and those incapable of giving consent. The right to privacy is connected with the requirement of providing effective protection of the stored samples, ensuring data confidentiality, and creating appropriate procedures of accessing and international transfer of samples and data.²² The main aim of ELSI analysis will be exploration of ethical, legal, and social conditioning of biobanking and developing a model of adequate ethical and legal regulation in this area. It will include openness to participate in population-based biobanking projects, ethical principles playing a role in biobanking processes; donors' rights, biobankers' obligations, and biobanking entities' activity; reviews of legal regulation in other countries and international ethical guidelines; surveys of social attitudes concerning data sensitivity, the social trust to biobanks, donors' rights, and social fears concerning biobank's activities, data access, and data/samples transfer. The national model of ethical guidelines and legal regulations should take account of international regulations, different regulations in other countries, national legal systems, and local sociocultural conditionings. In this MS will be included members of an expert group for legal regulations in biobanking and biomedical research constituted by the Polish Ministry of Science and Higher Education.

Discussion and Conclusion

Biobanks are essential for the development of scientific projects related to personalized medicine and one can say that these units contribute to better and more economical healthcare. Establishing a national network and national biobank node has been done in many European countries and clearly increased the “stocking ability” of all involved units, and gives an opportunity to store biological samples and data from a substantial proportion of the population, with a direct view to optimizing the scientific potential of genetic epidemiology. The current situation of Polish biobanks is not much different from what we have seen in Europe many years ago. However, the previous absence of decision activities related to the BBMRI-ERIC accession caused the suspension of certain work compared with what has happened in many European countries. Most probably our preliminary analysis of the Polish biobanks' situation showed only the tip of the biobanking iceberg. Nevertheless, the biggest issue is the fact that a very small percentage of samples is used for scientific projects, and unique patient cohorts are not accelerating the number of acquired scientific funds. There are a few reasons behind this:

(1) The biobank does not publish its resources, hence it is not visible on the biobanking map.

(2) The IT infrastructure is not coherent with European standards, hence it is difficult to use.

(3) The quality of samples is not defined due to a lack of standards and quality assessment tools.

(4) Patients are not aware that they can be more active in the field of science and development by donating their biological samples.

(5) There are no specific legal or bioethical norms dedicated to human biological materials used for scientific purposes; hence, Research Ethics Committees are reserved and cautious in the process of giving their opinions on scientific project based on biobanks.

(6) And finally, there is no dialogue between different scientific entities and between the pharmaceutical industry and scientific community; hence, a large amount of work in the field of biobanking is doubled.

Creation of the Polish national network will increase the visibility of samples and data that are stored in the national biobanking catalogue and will enhance research activities in the field of academic studies and collaboration with industry. If the BBMRI.pl application is considered positively, researchers will have to meet more access criteria, which will regulate sample flow and use. This will result in a greater impulse to settle ethical and legal matters related to the use of human biological material for research purposes. The access to data for researchers will be granted by an ethics commission, a scientific commission, and permitted by dataset/collection owners. In the ideal scenario, a national registry will be continuously enriched with the results produced during each scientific project. Researchers will profile new project proposals on the basis of what has been done in the past. Single collections will become more open to national and international scientific and commercial partnerships.

As a result of the project, the market of biobanking services formed by subsidiary stakeholders interested in biomedical research will make use of human biological material (cells, tissues, bodily fluids etc.) in the preclinical drug development and discovery research mainly funded by agencies of the government, demand on the pharmaceutical industry, academic research, and other life sciences institutions.²³ Some report data from the pharmaceutical and biobanking sectors in United States clearly indicate a global demand for human tissues and associated research, which in 2009 was estimated to be approximately $700 million, with the biobanking market place growing between 20% and 30% annually. The global market oriented on cancer technologies reached over $26 billion in 2012 and is expected to rise up to $30 billion in 2013. For the 2013–2018 period, the 5-year CAGR (compound annual growth rate) is estimated at 12.8%.¹⁶

Nevertheless, in all countries where the biobanking area is expanded, all entities (consumers and suppliers of biobanks service) comprise a relatively large market by themselves, which is a crucial factor for regional science and business development. Moreover, the formation of Expert Centers such as the Polish Network of Biobanks has become very important as well. Expert Centers ²⁴ are determined by a large number of expertise areas, very often with an ability to provide access to unique and brand new technologies, IT solutions, and professional quality management or partnership in project implementations. So, for all participants a beneficial win–win situation is created. On the evidence so far, cooperation between BBMRI-ERIC infrastructure Expert Centers and prominent pharmaceutical companies and biotech firms have been developed (AstraZeneca GmbH, Glaxo-Smith Kline, Genzyme Corp., Sanofi-Adventis, Pfizer etc.).²⁴

Thus, the considerations of the sense of the Polish network BBMRI.pl formation and the profits from the investment in it are unsubstantiated. It is now the right time to advance the activities in the Polish BBMRI.pl project. However, it requires more than a comprehensive understanding of all benefits. The list of examples of benefits is very long, but a few of them are presented as follows: (i) a reduction of the duration and cost of clinical trials and subsequent time to market for anticancer drugs; (ii) more precise patient diagnosis and the associated impact on better treatment and lower healthcare costs for providers, individuals, and the nation; (iii) improvements in research experiment time frames and data efficiencies; (iv) convergence to industry standards for biospecimen quality; (v) and optimization of capital infrastructure and IT technology.

Footnotes

Author Disclosure Statement

No conflicting financial interests exist.

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