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PL
The subject of the article is to present the possibilities offered by biobanks to the development of biomedical sciences, and in particular to genetic diseases. It also shows threats with the increasing use of genetic tests, especially so-called Direct to Consumer Tests.
PL
Biobanks for research purposes legal regulation is currently under debate. An important issue discussed is protection of the personal data collected in the biobank, including genetic data and other health data. This subject is extremely important given the current development of information technologies that allow for mass aggregation and analysis of personal information. This article describes the constitutional requirements for the discussed regulation, in particular regarding the privacy and informational autonomy of the individuals. The author refers in particular to the application of the proportionality principle.
EN
The development of research based on human biological material has contributed to a lively debate on the concept of informed consent in these studies, particularly its scope, form and length of validity. The biggest disputes and doubts concern the range of consent for research that will be conducted in the future, whose aim and place are unknown at the time of the sample collection, as are the future researchers and the ability to use the previously collected materials again. This situation raises the question of a just and prudent balance between the rights of participants in the research and the rights of researchers. New forms of consent have been proposed, which sometimes substantially diverge from the classical model (e.g. blanket consent or broad consent and its various kinds) in aiming towards responsible balancing between the necessity to protect the donors’ interests and the possibility of conducting research in medicine. These new concepts also find their application in legislative acts adopted internationally and in some European countries in the recent years.
PL
Rozwój badań naukowych opartych na wykorzystaniu ludzkiego materiału biologicznego przyczynił się do poważnej dyskusji wokół koncepcji świadomej zgody w tych badaniach, szczególnie jej zakresu, formy i długości obowiązywania. Największe spory i wątpliwości budzi zakres zgody na badania naukowe, które będą prowadzone w przyszłości, a konkretny cel badań, miejsce i badacze są nieznani w chwili pobrania materiału, a także możliwość ponownego wykorzystania wcześniej zgromadzonego materiału. Taka sytuacja rodzi pytanie o sprawiedliwe oraz roztropne zrównoważenie godności i praw uczestników badań, a także obowiązków i praw badaczy. Proponuje się nowe formy zgody, niekiedy odbiegające znacznie od jej klasycznego modelu (np. zgoda blankietowa, zgoda rozszerzona i jej odmiany), mające na celu odpowiedzialne zrównoważenie konieczności ochrony interesów dawców oraz możliwości prowadzenia badań naukowych w medycynie. Znajdują one również zastosowanie w aktach legislacyjnych przyjętych w ostatnich latach na forum międzynarodowym i w niektórych krajach europejskich.
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.
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