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Struktury wyjaśniania statystycznego. Warunek istotności statystycznej w analizie podgrup randomizowanych badań klinicznych

100%
RZEPIŃSKI T.
|
2018
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vol. 66
|
issue 2
65-86
PL
Przedmiotem analizy podjętej w artykule jest procedura wyjaśniania statystycznego. Dla potrzeb prowadzonych rozważań omówiony został szczególny typ badań biomedycznych, jakim jest analiza podgrup randomizowanych badań klinicznych. Pokazane zostało, że poprawności wyjaśnień statystycznych nie można ustalić, analizując wyłącznie strukturę eksplanansu, jak jest to przyjmowane w modelu istotności statystycznej (R-S), zaproponowanym przez W. Salmona. Procedura wyjaśniania statystycznego jest zatem, w przeciwieństwie do pozostałych form wy­jaśniania, zależna od procedur badawczych stanowiących podstawę formułowania twierdzeń statystycznych.
EN
The subject of analysis undertaken in the article is the procedure of statistical explanation. For this purpose a specific type of biomedical study, so called subgroup analysis of randomized clinical trials (SA), was discussed. It was shown that the validity of statistical explanations can not be determined by analyzing only the structure of explanation, as is the case in the statistical significance model (S-R) proposed by W. Salmon. Therefore, the statistical explanatory proce­dure is, in contrast to the other explanatory forms, dependent on the research procedures under­lying the formulation of statistical theorems.
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Conditions for the Admissibility of Scienti C Research in Biomedicine Biobanking: A Challenge in Times of Big Data

80%
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.
3
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Legal aspects of biobanking HBS for scientific purposes in Poland

71%
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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