Biobankų samprata ir status quo Lietuvoje

LTŠiame straipsnyje siekiama atskleisti žmogaus biobanko sampratą ir parodyti šios sampratos įvairiapusiškumą užsienio šalių praktikoje, dėl kurio dažnai atsiranda teisinių kliūčių bendrai plėtoti tarpvalstybinius ar tarptautinius mokslinius projektus, kurti europinį biobankų tinklą. Kartu bandoma palyginti biobanką su kitomis biologinių mėginių kolekcijomis ir nustatyti, koks biobanko apibrėžimas galėtų būti priimtinas Lietuvoje. Galiausiai, daug dėmesio straipsnyje skiriama atskirų Lietuvos Respublikos įstatymų analizei, siekiant įvertinti, ar esama teisinė aplinka sukuria pakankamą pagrindą kurti ir plėtoti specifinius mokslinius biobankus Lietuvoje. Šis straipsnis – įvadas į daug detalesnę, su moksliniais biobankais susijusių probleminių klausimų analizę.

ENThere are various definitions of biobanks. One version says that biobank is a dully organized system which stores and manages human biological samples and medical documents for the sole purpose – to achieve scientific research goals. Shortly speaking, a biobank is a place with special tanks where samples of human organs, their parts, tissues, cells or their components, taken from the human body, are stored. All these components have a general name – biological material. Although it seems simple, however, it appeared that due to the lack of harmonized European and international harmonization of biobanks, each country and even institute uses its own definition (e.g., biolibrary, genetic data base and etc.), has a different understanding and a way in how to regulate this institute. Two main tendances could be indicated: (i) to create a special biobank law; or (ii) to include specific aspects into exsiting laws. Therefore, the aim of this article is not only to find the best definition (understanding) of the biobank for Lithuania, but also to analyse the existing legal environment. This analysis of the laws has shown that there is neither direct regulation of research biobanks, nor possibility to use the laws by the analogy. Such aspects as a consent for biobank, data protection, biomaterial and responsibility should be specifically regulated in order to protect the participants of the biobank. However, the overregulation itself should not be seen as a value, therefore, deeper analyses of all questions should be maid in order to decide, if research biobanks in Lithuania should be regulated in a separate law. In case it would be decided to specify already exsiting laws – the Law on the biomedical research ethics could be the best choise, as it is the most related with biomedical researches, indicates general ethical principals.