Order No. KR DCM-328/2020 of the acting Minister of Public Health validating the Regulation on establishment and operation of biobanks.”

This Order establishes the procedure for the establishment and operation of biobanks. Biobank shall be intended a specialized storage of biological materials for scientific and biomedical purposes (including samples of cells, tissues, deoxyribonucleic acid, ribonucleic acid genetic material of human and/or animal and/or plant genetic material, and other biological and genetically modified substances and organisms). Biological materials of preclinical (non-clinical) clinical tests stored in biobanks, collected in accordance with the legislation of the Republic of Kazakhstan, norms of bioethics, in compliance with all requirements for sample preparation, transportation, laboratory processing and storage. A biobank shall be established on the basis of a healthcare organization, an organization of higher and (or) postgraduate education and scientific organization on the basis of: (a) a positive opinion of the Central Bioethics Commission issued in accordance with the Standards of Activities of Bioethics Commissions approved by the Central Commission; and (b) a positive opinion of the Biosafety Commission of a research center (if any) or an expert on biosafety from a third-party organization in case of the absence of Biosafety Commission under research center. Biobank activities include: (a) collection, incoming visual quality control, storage of samples of biological materials, including samples of cells, tissues, deoxyribonucleic acid, ribonucleic acid genetic material of human and/or animal and/or plant, and other biological and genetically modified substances and organisms; (b) issuance of biological materials to researchers according to their developed inclusion criteria; (c) accounting of stored samples of biological materials and associated medical, demographic and laboratory information, maintenance of an electronic database; (d) storage of collected samples of biological materials, observance of temperature regimes, and availability of reserve sources of power supply, which guarantees full safety of accumulated biomaterial; (e) provision of services of collection, processing, storage and analysis of biological materials for researchers and research teams at the research center; (f) interaction with other Kazakhstan and foreign biobanks; and (g) exchange of samples of biological materials between biobanks and medical organizations.