Wyniki wyszukiwania - Biblioteka Nauki

1

The idea for... biobank – just a few words

100%

Uchańska J.

Edukacja Biologiczna i Środowiskowa

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2017

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nr 1

26-32

EN

The use, collection and modification of human biological material/the human body is a difficult, controversial and challenging subject demanding deep analyses of all the ethical, social and legal aspects. Use of the human body for experimental purposes for or without the reward is often criticized. It is clear, however, that not all researches on new medicinal products, medical devices or cosmetics can be carried out on animals only. Contribution of a human being in experiments and clinical trials (including organs, tissues or cells) is the only way to verify safety and efficacy of a tested method or substance. Storage of human biological material intended for tests demands meeting conditions provided by legal standards and showing respect for the human body and human dignity; that is why biological material must be, as a rule, stored in cell and tissue banks (biobank). Any entity that wants to operate a biobank must meet a number of complex requirements before entering this narrow, difficult and demanding market. This is the result of legislative chaos and fragmentation of laws at the national and EU level, but also social, ethical or religious prejudice. However, biobanks are an indispensable research tool for understanding genetic or environmental grounds of many diseases, e.g. hereditary ones. Biobanks can undoubtedly revolutionize the health market and contribute to the further development of personalized medicine. However, the entity willing to establish a cell and tissue bank must meet and take into account several criteria. Any entity considering the foundation of a biobank wonders whether this activity will be profitable and whether it can be included in the chain of clinical trials.

2

The European Bank for Induced Pluripotent Stem Cells (EBiSC): Opportunities & Challenges Through Public-Private Collaboration

71%

George C. C.

Studia Iuridica

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2018

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tom 73

29-41

EN

The European Bank for induced Pluripotent Stem Cells is a global iPSC research resource designed to overcome inadequacies in iPSC research and banking services in order to make a diverse collection of quality-controlled iPS cell lines and genetic data easily accessible to researchers in Europe and worldwide. Opened to the public in 2016, EBiSC is a joint undertaking of the Innovative Medicines initiative of the European Commission, and the European Federation of Pharmaceutical Institutes and Associations (EFPIA), in collaboration with a consortium of international experts from the iPSC community in academia, government and business. The paper identifies opportunities for this largescale resource through collaboration across the public and private sectors, and highlights challenges encountered during its establishment with regard to cell line provenance, a multiplicity of actors and interests, intellectual property rights restrictions, ownership of banked material, and management of access to genetic data.

3

Biobank Łódź – population based biobank at the University of Łódź, Łódź, Poland

70%

Dobrowolska S. , Michalska-Madej J. , Słomka M. , Sobalska-Kwapis M. , Strapagiel D.

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tom 2

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nr 1

85-95

EN

Biobank Laboratory of the University of Lodz is a unit in the organizational structure of the Department of Molecular Biophysics at the Faculty of Biology and Environmental Protection. It was established in 2014 as one of the results of the TESTOPLEK project. One of the main goals of the unit is to collect and share biological material of human origin and related clinical and survey data. Moreover, Biobank Laboratory conducts work in the field of genetics and molecular biology on human biological material. Biobank Laboratory gathers over 40.000 samples such as DNA, FFPE, saliva, together with their data. Data about collections is available for researchers in directories e.g. BBMRI-ERIC Directory 4.0. Since 2014, the unit belongs to the national Consortium BBMRI.pl, and since 2017 it executes a project entitled Research Infrastructure for Biobanks and Biomolecular Resources BBMRI-ERIC, co-creating the Polish Network of Biobanks. Biobank Laboratory is focused on cooperation with domestic and foreign scientific institutions and medical units, as well as entities from the local, business and public sector.

4

Survey design method – the key component of building the Polish Biobanking Network

70%

Paluch A. , Chróścicka A.

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2021

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tom 4

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nr 1

65-70

EN

The Polish Biobanking Network was created to connect Polish biobanks and gain information about their collections, thus facilitating their cooperation both in the national and international area. Based on MIABIS (Minimum Information About BIobank data Sharing) and considering the specificity of the Polish scientific community, two surveys were created. The aim of the first survey was to collect general information about Polish biobanks, e.g. their localization and type of collected material. The second survey was more detailed and concerned the biobank’s structure, information about collected material, willingness to share the collected material, implementation of an informatics system. Significant information about Polish biobanks could be obtained through appropriate recognition of the biobank’s scope of practice and correctly asked questions. The analysis of collected results could give a full picture of Polish biobanks.

5

Legal aspects of biobanking HBS for scientific purposes in Poland

44%

Krekora-Zając D.

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2019

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nr 4 (220)

165-184

EN

Legal issues related to the biobanking of human biological samples are one of the extremely important areas of European law. Biobanks created in Poland as well as the Polish Biobank Network created under the auspices of the Ministry of Science and Higher Education have become a catalyst for the search for solutions and the basis of rights for the functioning of biobanks in Poland as well as the protection of donor rights. Undoubtedly, the lack of legal regulation of biobanks and biomedical research on human biological samples could become a significant problem limiting the development of biobanking and conducting scientific research in Poland. The research attempts to show how representatives of the doctrine of law, bioethics and sociologists have interpreted the principles and standards of biobank operation in Poland from basic human rights, constitutional norms and personal rights.