The Types of Biological Databases (Biobanks)

Abstract

In the world, it is customary to create biological databases of different species. And initially, the databases for the investigation of crimes were widespread. However, later, when their potential and benefits, including for medicine, were assessed, the databases for other areas appeared. Russia was no exception in this regard. Although, in our country, unlike foreign states, the activities of biological databases based on purposes other than the disclosure of crimes are practically not regulated in any way. This article deals with the analysis of legal regulation of biobanks in the Russian Federation and abroad. Special attention is paid to the classification of biobanks. The purpose of the study is to determine the feasibility in the legislative regulation of their activities, as well as the patterns in such a regulation. To achieve this goal, the authors studied extensive regulatory material, which included EU directives and national regulations of the EU member states. The methodological basis of the study was the general scientific and private scientific meth-ods of research. Of course, such private scientific research methods as the comparative-legal method and the formal legal method have been widely used. Due to the comparative legal analysis, it is established that the EU countries have a high level of legislative activity in terms of determining the legal regime of biological databases. All countries recognize the specifics of such a legal regime, which can largely be explained by a special legal nature of biological samples and biological data. In this regard, the following issues related to the activities of biological databases are reflected everywhere in the EU countries at the level of law: the procedure for their creation; the procedure for receiving, processing, storing and transmitting biological samples and the data obtained on their basis; the rights and obligations of database creators and persons who have provided their biological samples and biological data about themselves; a set of measures aimed at protecting the rights and interests of donors and third parties, etc. As it seems, a similar approach to the regulation of the activities of biological bases estab-lished not for the investigation of crimes should be implemented by Russia. At the same time, special attention should be paid to the research of biological databases. In the Russian Federa-tion, they are created, as a rule, at the local level. Their main drawback is that they are sepa-rate sources of limited biological information, functioning independently of each other while comprehensive (concentrated in one place) information can bring invaluable benefits and advantages for Russian science and medicine as a whole. However, this requires the estab-lishment of an appropriate legal framework.

Biobanks as an important tool in modern translational oncology

“…Compliance with these requirements distinguishes biobanks from research collections of specimens. Aforementioned, biobanking requires compliance with legal regulations, which vary from country to country and in some aspects may not be fully regulated and fall into a so-called "legal gray zone" (comprehensively reviewed in Doludin et al, 2019;Nadelyaeva, 2020;Gorbunova, 2020;Boltanova and Imekova, 2021;Khokhlov et al, 2021). Thus, it's important to know and take into account the difference in legal norms related to biobanks in different countries, especially at the stage of setting up a new biobank or merging several biobanks from different countries into consortium.…”

“…Historically, human biomaterial biobanks are subdivided into population biobanks (i.e., focusing on samples collected in certain populations) and nosological biobanks (i.e., focusing on certain diseases), but another classification is also possible, including subdivision into virtual biobanks, image biobanks, etc. (Coppola, 2019;Boltanova and Imekova, 2021). Nosological ones, in turn, can be subdivided into unspecialised biobanks (e.g., collections of biosamples from various human diseases) and specialized ones (e.g., collections of samples related to a particular type of malignant tumor).…”

“…Also, biobanks can be classified as local, regional, state and international. Most of the currently existing large regional, state and international biobanks have been described in detail in the national literature (Reznik, Kuzmin, Skvortsov, and Reznik, 2016;Boltanova and Imekova, 2021). Many biobank resources are currently being pooled, for example the Global Biobank Metaanalysis Initiative (GBMI) brings together a network of 19 biobanks from 4 continents and includes samples from over 2.1 million donors (Zhou et al, 2022).…”