Global Biosecurity (Jul 2023)
Poland - National regulation on processing data for scientific research purposes and biobanking activities
Abstract
Biobanks raise great hopes for future research that can help understand many diseases and find ways to treat them. The purpose of the article is to study the legislative acts regulating the activities of biobanks in Poland and to formulate recommendations for improving the legal regulation of biobanking. For the purpose, tasks, object, and subject of research, both general scientific and special methods of scientific knowledge were used in the work. General scientific methods (dialectical; system analysis; formal-logical) are fundamental legal techniques, and means of research. To improve the current legislation of Poland, the following can be proposed. Develop a legal framework that regulates the legality of obtaining samples of human biological materials (both normal and pathologically altered) for submission to the biobank in Poland. Regulate at the legislative level the requirements regarding the organizational and legal form of the creation of a biobank, the legal basis of its functioning, the form of ownership, and financing. Thus, the creation of an effective system of biobanks in Poland with systematic collections of biological samples obtained from people with various diseases, their storage in appropriate conditions, the development of internal documentation and standard operating procedures, taking into account both the ethical and legal components, is of key importance for the formation and development of domestic science, development of innovative medicines, methods of diagnosis and monitoring of diseases.