Legal Framework of Creation and Functioning of Biobanks (Biorepositories) in Ukraine
Abstract
problem setting. The article studies the question of creation and functioning of biobanks (biorepositories) in Ukraine. The author classified the world biological banks. The definition of biological bank (biorepository) is suggested. The author analyzed the available in Ukraine legal framework, which governs the relations in creation of banks of human cells and tissues. The article shows imperfection of government of the abovementioned relations on the level of national legislation in comparison with the global practice. The article defines suggestions for improvement of the legislation in-force. Analysis of recent researches and publications. The following Ukrainian and foreign scientists developed and implemented the principles of personalized, predictive and preventive medicine and bioethics issues in healthcare (in particular in transplantation of human cells and tissues) in Ukraine: G. A. Biletska, I. V. Venedyktova, R. Y. Hrevtsova, V. I. Hryschenko, L. M. Deshko, O. Y. Kashyntseva, I. Y. Seniuta, S. G. Stetsenko and others. In addition, it should be noted, that the system legal researches and substantial analysis of the legal and economic background for creation and functioning of biobanks (biorepositories) in Ukraine were not conducted, and there are no available publications. Target of research. The purpose of the research is analysis of the legal aspects of such selected by the author of economic activities, as biobanking, namely: the legal forms of performance of activities and funding mechanisms for biological banks (subject to conditions of public-private partnership), peculiarities of selection of samples for biobanks, the problem of transfer of biological samples (cells and tissues) between the created biobanks in Ukraine and transborder transfer, and observance of patient’s (donor’s) rights. Article’s main body. Biorepository is the place, where biological materials are collected, processed, stored and distributed in order to support multidisciplinary, multicenter and other scientific studies and research projects. In biorepositories the samples of animals, human biological materials, and other living organisms may be stored. The biobank is the form of biorepository, where the organized collections of human samples and the related information for research purposes are stored. In Ukraine biorepositories and biobanks are represented only by banks with cord blood / stem cells and individual collections of biological tissue samples in healthcare institutions, higher medical educational institutions and research institutions. Conclusions and prospects for the development. For the purpose of improvement of the current legislation, the author suggests the following: 1. To develop the legal framework, regulating the legal order of sampling of human biological materials (both normal and pathologically changed) for depositing them in biobank in Ukraine. 2. To determine the procedure for collection of human biological samples, taking into account the international experience and core principles of biomedical ethics (obtaining of the informed consent of the potential donor, approval of the protocols of collection and informed consent form by the ethics committee under the healthcare institution, possibility of deposition in biobank of the samples, collected after carrying out of pathomorphological and other studies, i.e. work with hospital wastes with protection of anonymity). 3. To regulate on legislative level the requirements for legal form of biobank creation, legal frameworks for its functioning, form of ownership, funding. 4. To practice the legal mechanism of completing the biobank, supply of the new biological samples (preparation by anatomic pathology departments or healthcare institutions, exchange with foreign biobanks, temporary use). 5. To regulate problems of ownership for biological samples stored in biobank (preservation of donors’ rights). 6. To develop the system of standards and rules for biobanks functioning.
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