Legal Status of the Biobank (Bank of Biological Human Material)
Abstract
The article defines a biobank as a commercial or non-profit organization professionally engaged in the collection, testing, processing, storage of human biomaterials and its fixation in the database, as well as in some cases addition-ally — scientific research and (or) the provision of biomaterial to individuals and institutions under certain conditions for a fee or free of charge. The legal capacity of the bank of biological samples is special, since it is associated with the specifics of the field of activity — biomedicine, specifics of methods used — biotechnologies, including genomic technologies, and the specifics of the storage facility containing human genomic information. Activities of biobank is implemented by means of conclusion and execution of civil contracts of donation for scientific, therapeutic activities, agreements on the fence and long-term storage of biological material, etc. The principles of biobank activity are substantiated: 1) observance of confidentiality of donors and their informing on the purposes of use of bio-materials, 2) ensuring the safety of the bank's employees in contact with bio-logical materials, 3) availability of biomaterial for scientific research on condition of anonymity of donors and clients and (or) their consent to such use, 4) providing profit to the founders and sponsors of biobank, including through the alienation of donor biomaterials, simplifying the procedure for obtaining donor consent. It is proposed to preserve state and non-state banks of human biological samples. The biobank property (property supporting the biobank activity, and the biomaterials stored) is grouped in order to secure a special legal regime for each group. Human biological materials are characterized as things limited in circulation. The basic rights of the organizations — founders, recipients of biomaterial, grantees are revealed: 1) the right to profit, 2) the right to trade secrets, 3) the right to freedom of conclusion and content of contracts with human biomaterial. The proposed method of termination of activities of the Biobank is taking into account the interests of its customers.
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