Agreements on biobanking of human biological samples for scientific purposes

In the 20th and 21st centuries, the development of medicine, pharmacy, genetics, and the related knowledge about human beings has been extraordinary. These sciences can only develop through scientific research conducted on biological samples obtained from very large groups of donors. No scientist can independently collect a sufficient number of samples to conduct credible research, which is why biobanks are being established worldwide, engaged in collecting, securing, storing, and making available large collections of biological samples for scientific purposes. The idea of biobanking was recognized by Time Magazine as one of the leading ideas that can change the world. The development of biobanks has also generated the development of the entire biomedical industry, based on high technologies. It is estimated that the value of the biobanking market in 2014 was 14.4 billion dollars, and in 2018 it will reach 22.7 billion dollars. The unprecedented quantity of collected biological samples, which contain information about genetic, health, and genotypic characteristics, contributing to the development of personalised medicine, can cause many threats related to eugenics, discrimination, and respect for human dignity. Furthermore, the lack of defined legal principles for agreements concluded by biobanks creates uncertainty regarding the legality of such agreements. This uncertainty directly affects limitations in conducting scientific research, and consequently, slows down the development of human science. The subject of analysis within the requested grant will be agreements on biobanking for scientific purposes. According to the definition established by the European Group on Ethics in Science and New Technologies appointed by the European Commission, a biobank is a term for various types of collections of biological samples along with associated databases, which have a certain level of accessibility, availability, and exchange for scientific purposes. The lack of legal regulation regarding the functioning of biobanks in Poland is unjustified and harmful from the perspective of legal transactions, freedom of research, and above all, the protection of the rights of biological sample donors. The research project presented by me will serve to comprehensively develop the doctrinal study of agreements on biobanking human biological material and to specify conclusions regarding future legal regulation. The first scientific objective of the research is to describe the essence, legal nature of the rights, and obligations of donors, biobanks, and scientists related to the use of human biological samples for scientific purposes. The second is to define the principles of admissibility of transferring biological samples by donors to biobanks, scientists, and between biobanks. The third research objective is to analyse the Polish and European legal order in terms of the rights and obligations of donors, biobanks, and scientists using biological samples originating from biobanks. The fourth main research objective is to determine the relationship between the legal regulation of this issue and the agreements concluded by biobanks. The analyses will serve to define the legal framework of agreements concluded by biobanks. The objective will be achieved through a legal analysis of all agreements concluded by biobanks regarding the transfer of human biological samples. The necessity of analysing this contractual issue stems from the lack of legal regulation in this regard, and all attempts at statutory regulation have failed. The research carried out under the project is not limited only to Polish law and will also cover European regulations, including those developed by organisations associating biobanks. Furthermore, agreements concluded in the United Kingdom by the UK Biobank, which is one of the largest biobanks in the world, and Swedish biobanks, which are among the oldest, will also be analysed. The necessity of broad comparative legal research also stems from the fact that in Polish law, in the absence of legal regulation, this topic is not the subject of scientific discussion, and as J. Pawlikowski's research shows, it is the subject of many concerns in Polish society. The proposed research is fundamental and innovative for the operation of biobanks, also for the development of genetics, medicine, pharmacy, or biotechnology. These are the first studies concerning the civil law aspects of biobanking in Poland, and the publication of their results will increase public awareness of biobanking, which will contribute to greater legal awareness of donors and their increased number. Various research methods will be applied in the research, depending on the subject and purpose of the research. Using, among others, the comparative legal method, I will describe the legal regulations concerning the civil law aspects of biobanking in countries such as Sweden and the United Kingdom. The aim of this research will be to show the differences and similarities in the regulation of biobanking agreements in these countries and to draw conclusions de lege ferenda in relation to the future Polish regulation of this issue.