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

100%
Uchańska J.
Edukacja Biologiczna i Środowiskowa
|
2017
|
issue 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
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The European Bank for Induced Pluripotent Stem Cells (EBiSC): Opportunities & Challenges Through Public-Private Collaboration

71%
George C. C.
Studia Iuridica
|
2018
|
vol. 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
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Legal aspects of biobanking HBS for scientific purposes in Poland

44%
Krekora-Zając D.
Studia Prawnicze
|
2019
|
issue 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.
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