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Paradigmatic crisis and biomedical research

100%
Di Scala E., Di Scala N.
Annales Universitatis Paedagogicae Cracoviensis. Studia ad Didacticam Biologiae Pertinentia
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2016
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issue Annales Universitatis Paedagogicae Cracoviensis Studia ad Didacticam Biologiae Pertinentia VI (2016)
71-84
2
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Regulace biomedicínského výzkumu

51%
Lančová P.
Časopis zdravotnického práva a bioetiky (Journal of Medical Law and Bioethics)
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2021
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vol. 11
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issue 1
21-35
EN
This article deals with the issue of the regulation of biomedical research. The article first discusses the term biomedical research in general, including its subsets and methods of classification. The historical context, which had a fundamental influence on the development of regulation, is also elaborated. Furthermore, the article deals with ways of regulating biomedical research. It deals with non-legal regulation, ie ethical regulation and regulation in the form of technical-organizational standards. Finally, the legal regulation is discussed, at the international, European and national levels.
CS
Tento článek se zabývá problematikou regulace biomedicínského výzkumu. V článku je nejprve pojednáno obecně o termínu biomedicínského výzkumu, včetně jeho podmnožin a způsobů členění. Rozvedeny jsou také historické souvislosti, které měly na vývoj regulace zásadní vliv. Dále se článek věnuje způsobům regulace biomedicínského výzkumu, je zde rozebrána regulace mimoprávní, tedy etická regulace a regulace ve formě odvětvových a profesních standardů. V závěru je pak pojednáno o regulaci právní, a to na úrovni mezinárodní, evropské i národní.
3
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Conditions for the Admissibility of Scienti C Research in Biomedicine Biobanking: A Challenge in Times of Big Data

51%
Krekora-Zając D.
Studia Iuridica
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2018
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vol. 73
57-71
EN
The subject of the article is the analysis of the rights of donors donating their biological samples to biobanks in the 21st century. Issues regarding donor rights have been analyzed since the 1980s, however, changing times, creating Big Data databases as well as evolving legal awareness of donors meant that today the role of donors in the biobanking process should be perceived differently. Donors become active subjects of scientific research which is connected with the need to answer questions about the obligations to inform them about the results of scientific research conducted on their samples or incidental findings. Likewise, the combination of data registers and the creation of Big Data basis require the re-thinking of terms such as the protection of personal data of donors or the anonymisation of their data. These issues are imposed by negligence or complete lack of legal regulation of the biobanking, which makes the legal protection of the rights of donors dependent on the will of a particular biobank. All these phenomena result in the necessity of new approaches to the rights of donors and their inclusion in the future legal regulation.
4
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Legal aspects of biobanking HBS for scientific purposes in Poland

32%
Krekora-Zając D.
Studia Prawnicze
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2019
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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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