scholarly journals Contemporary Challenges and Legal Regulation of Genome Research: Some Considerations

2021 ◽  
Vol 8 (1) ◽  
pp. 36-67
Author(s):  
A. V. Kubyshkin
Keyword(s):  
Science And Technology ◽  
Legal Regulation ◽  
Information Space ◽  
Human Reproduction ◽  
Genomic Research ◽  
Genome Research ◽  
Commercial Use ◽  
Blockchain Technology ◽  
Basic Concepts

The paper studies some aspects and considerations of the legal regulation of genomic research in the context of modern challenges. Approaches to the formulation of some basic concepts in the field of bioinformatics, such as information, information space, are proposed, the importance of these concepts for legal regulation is substantiated. Approaches to the legal regulation of the commercial use of the results of genomic research in the field of bioinformatics are formulated. Approaches to the legal regulation of the activities of biobanks are proposed based on the analysis of the possibility of using blockchain technology to improve the functioning of the biobank, the possibility of attracting investments through crowdfunding financing. The classification of biobanks according to various criteria is given. Approaches to the formulation of such concepts as donation and parenthood are determined within the framework of the legal regulation of genomic research in the field of human reproduction. The influence of modern challenges associated with the development of science and technology on the formulation of these concepts is considered. Approaches to solving the problem of ensuring a balance of private, group and general interests in the field of legal regulation of genomic research are proposed.

scholarly journals SPECIFICS OF LEGAL REGULATION IN GENOMIC RESEARCHES AT THE INTERNATIONAL AND EUROPEAN LEVEL

2020 ◽  
pp. 68-78
Author(s):  
P. A. Kalinichenko ◽  
M. V. Nekoteneva
Keyword(s):  
Self Regulation ◽  
Legal Regulation ◽  
Human Reproduction ◽  
Genomic Research ◽  
The European Union ◽  
Genome Research ◽  
Council Of Europe ◽  
Human Genomics ◽  
European Regional

This article is devoted to the analysis of diff erences in approaches and in choice of tools at the international (universal) and European (regional) levels of interaction between states in the regulation of relations in the fi eld of genomic research and the implementation of their results. The article analyzes specifi cs of approaches at the universal and regional level, including activities of the UN family bodies, the Council of Europe, the European Union in the fi eld of protecting human rights and human genomics. Special attention is paid to the role of international soft law in the development of legal regulation (self-regulation) in the mentioned fi eld. The materials of the article can be useful both in theoretical and practical jurisprudence, and may also be of interest for other areas of the human genome research (bioinformatics, medicine, human reproduction, etc.).

scholarly journals Ethical aspects for genomic research in psychiatry

2019 ◽  
pp. 41-42
Author(s):  
N. V. Semenova
Keyword(s):  
Genetic Counseling ◽  
Side Effects ◽  
Genetic Factors ◽  
Legal Regulation ◽  
Genomic Research ◽  
Medical Genetic ◽  
Ethical Aspects ◽  
Methodological Issues ◽  
Factors Associated

The genomic research is one of the most dynamically developing fields both in the worldwide and in Russia. Currently, the genetic approaches in psychiatry are used to solve the practical and scientific problems related to medical genetic counseling, identification of the genetic factors associated with characteristics of metabolism of medicines or development of their side effects, as well as to develop the new approaches to classification of psychiatric disorders. Given the complexity and the unresolved nature of the several methodological issues related to ethics and protection of the rights of patients with mental disorders, the legal regulation of genomic research in this category of patients is a specific interdisciplinary challenge which solution requires combining of the competencies of lawyers, medical ethics specialists, psychiatrists, psychologists, geneticists.

scholarly journals Results of genomic research as the objects of civil law

2020 ◽  
pp. 54-61
Author(s):  
Olesia Valer'evna Belaia
Keyword(s):  
Intellectual Property ◽  
Civil Law ◽  
Legal Regulation ◽  
Genomic Research ◽  
Property Law ◽  
Intellectual Property Law ◽  
Universal Definition ◽  
Original Classification

The object of this research is the determination of means of establishing the results of genomic research as the objects of intellectual property. The author analyzes the Russian normative legal acts regulating the questions of conducting genomic research and securing the rights to their results. The problem of absence of the universal definition and conceptual framework for genomic research in the national legislation is indicated. Analysis is carried out on the defended in legal community scientific positions pertaining to the need for separate consolidation and legal regulation of each type of product or organism that contains genes, or derivative from biomaterial, as well as the genes and genome themselves. The main conclusions consists in formulation and substantiation of the concept of “genomic research” and the results of genomic research. The original classification of the results of genomic research into static and dynamic is proposed. The author believes that the intellectual property law is most suitable for legal regulation and consolidation of the rights to results of genomic research. Inexpedience of determining each type of product or organism that creates or contains biomaterial as an object of intellectual property is substantiated. The author holds that the amendments to legislation should be introduced in exceptional circumstances when a new object possesses unique characteristics, and the existing tools of intellectual property law do not allow reflecting its specificity and protect the interests of its bearer.

scholarly journals LEGAL AND ORGANIZATIONAL ASPECTS OF PERFORMANCE OF GENOME RESEARCH IN THE USA

Issues of Law ◽  
2020 ◽  
Vol 20 (3) ◽  
pp. 13-19
Author(s):  
S.A. Vasiliev ◽  
◽  
A.M. Osavelyuk ◽  
A.K. Burtsev ◽  
◽  
...  
Keyword(s):  
The United States ◽  
Legal Regulation ◽  
Genomic Research ◽  
Genome Research ◽  
Medical Activity ◽  
Department Of Health ◽  
The Us ◽  
The Usa ◽  
The Russian Federation ◽  
Clinical Advances

This work is devoted to the legal regulation of the organization of genomic research in the United States. On the territory of this state, an approach that is atypical for the Russian reality is used, according to which the bulk of genomic research is regulated by an organization subordinate to the US Department of Health. The article analyzes some of the problems associated with diagnostics and genome editing, in conclusion, a comparison with Russian realities. This study is of interest in view of the fact that the Russian Federation, having a solid groundwork in medical and clinical advances in this area, has practically no legal regulation in order to effectively implement these areas of medical activity. Taking into account foreign experience can be useful for Russia, of course, based on domestic specifics in the process of forming a regulatory framework for treatment using genomic research.

scholarly journals International Legal Regulation of Genetic Research and Implementation of International Legal Standards in this sphere into Russian Legislation

2021 ◽  
Vol 25 (1) ◽  
pp. 107-125
Author(s):  
Aleksey V. Kubyshkin ◽  
Sergey V. Kosilkin
Keyword(s):  
Human Rights ◽  
Public Relations ◽  
Genetically Modified Organisms ◽  
Genetic Research ◽  
Legal Regulation ◽  
Genomic Research ◽  
Public Interests ◽  
Legal Standards ◽  
Blockchain Technology ◽  
Protection Of Human Rights

The article analyzes the topical issues of international legal regulation of genetic research; it provides a comparative analysis of two groups of international acts regulating relations related to genetic research and application of their results on creation, use and circulation of genetically modified organisms (except humans), on the study of human genome and application of their results. The article deals with the issues of objects and methods of genetic research regulation, balance of interests as the basis for legal regulation of public relations in the field of genomic research. It also considers approaches to ensuring a balance of private, group and common (public) interests. Criticism of certain provisions of the Convention on Human Rights and Biomedicine is given, the question of the inadmissibility of legal opposition between the protection of human rights and the interests of science and society as a whole is raised. The authors put forward proposals on the implementation of a number of international norms in Russian legislation and its further improvement, as well as on the use of blockchain technology in genetic research.

Activity of public control entities and development of distributed computing and distributed data storage systems

2018 ◽  
pp. 14-22
Author(s):  
D. V. Gribanov
Keyword(s):  
Distributed Computing ◽  
Data Storage ◽  
Storage Systems ◽  
Legal Regulation ◽  
Distributed Data ◽  
Distributed Data Storage ◽  
Public Control ◽  
Blockchain Technology ◽  
Legal Method ◽  
Digital Assets

Introduction. This article is devoted to legal regulation of digital assets turnover, utilization possibilities of distributed computing and distributed data storage systems in activities of public authorities and entities of public control. The author notes that some national and foreign scientists who study a “blockchain” technology (distributed computing and distributed data storage systems) emphasize its usefulness in different activities. Data validation procedure of digital transactions, legal regulation of creation, issuance and turnover of digital assets need further attention.Materials and methods. The research is based on common scientific (analysis, analogy, comparing) and particular methods of cognition of legal phenomena and processes (a method of interpretation of legal rules, a technical legal method, a formal legal method and a formal logical one).Results of the study. The author conducted an analysis which resulted in finding some advantages of the use of the “blockchain” technology in the sphere of public control which are as follows: a particular validation system; data that once were entered in the system of distributed data storage cannot be erased or forged; absolute transparency of succession of actions while exercising governing powers; automatic repeat of recurring actions. The need of fivefold validation of exercising governing powers is substantiated. The author stresses that the fivefold validation shall ensure complex control over exercising of powers by the civil society, the entities of public control and the Russian Federation as a federal state holding sovereignty over its territory. The author has also conducted a brief analysis of judicial decisions concerning digital transactions.Discussion and conclusion. The use of the distributed data storage system makes it easier to exercise control due to the decrease of risks of forge, replacement or termination of data. The author suggests defining digital transaction not only as some actions with digital assets, but also as actions toward modification and addition of information about legal facts with a purpose of its establishment in the systems of distributed data storage. The author suggests using the systems of distributed data storage for independent validation of information about activities of the bodies of state authority. In the author’s opinion, application of the “blockchain” technology may result not only in the increase of efficiency of public control, but also in the creation of a new form of public control – automatic control. It is concluded there is no legislation basis for regulation of legal relations concerning distributed data storage today.

Problems of Legal Regulation in the Digital Space Relations

2020 ◽  
Vol 2 (2) ◽  
pp. 126-147
Author(s):  
A. N. Vashchekin ◽  
◽  
A. V. Dzedzinsky ◽  
Keyword(s):  
Theoretical Basis ◽  
Legal Regulation ◽  
Digital Environment ◽  
International Treaties ◽  
Digital Rights ◽  
Digital Space ◽  
Legal Method ◽  
Balance Of Interests ◽  
Basic Concepts ◽  
The Right

Introduction. The era of digitalization sets for researchers the task of systematizing the essential features of digital space, identifying the essence of the “right to the Internet” and the legitimacy of limiting the digital rights of citizens. Theoretical Basis. Methods. The authors studied the peculiarities of the digital environment as a specific integral area of legal regulation, the doctrine and legislation of several countries on the topic which determines the basis for the regulation of digital space in Russia. The formal legal method, synthesis, analysis, induction and deduction were used as research methods. Results. The wording of the basic concepts in the area under study is proposed: digital space, digital region, digital platform, etc. The measures to eliminate “digital wells” are indicated. The main properties of the information space and its derivatives are considered. The effects of any contradictions in the legislation of the country are shown. Discussion and Conclusion. As the study showed, the latest innovations in the legislation contravene the principle of the balance of interests, fail to meet the requirements of observing the rights of a person and citizen, and contradict the Constitution and international treaties of Russia. When comparing these measures with their foreign counterparts, a search was made for their potential shortcomings and proposals were presented on possible directions for their correction, taking into account the particular characteristics of digital space.

Medico-Social Examination: the Modern Aspects of Legal Regulation

10.12737/5942 ◽  
2014 ◽  
Vol 8 (1) ◽  
pp. 1-6
Author(s):  
Разиньков ◽  
D. Razinkov ◽  
Михайлов ◽  
I. Mikhaylov ◽  
Михайлова ◽  
...  
Keyword(s):  
Legal Regulation ◽  
The State ◽  
Government Support ◽  
Sociological Research ◽  
Constitutional Rights ◽  
Disabled People ◽  
Government Programs ◽  
Social Sphere ◽  
Traditional Classification

In article the legislative base, which is the foundation of functioning of the state system of medical-social examination, is considered and analyzed. The questions of legal regulation of the state activity in the sphere of social policy concerning disabled people are discussed. The methods of sociological research and logical analysis of literature and official normatively-legal papers, being the basis of activity of the system of medico-social examination and sphere of giving to the invalids the equal with other citizens possibilities in realization of constitutional rights and freedoms, public welfare and establishment, are applied to the invalids as the measures of government support. In conclusions the emphasis is placed on need of carrying out radical restructurings for system of medico-social examination. It is offered to modify the existing classification of indexes of health and indexes, related to the health taking into account the socio-economic, climatic and other features; to strength the control of execution of government programs in the medico-social sphere; to modify the traditional classification of groups of disability; to change a way of features accounting of disabled people with various functional violations proceeding from a complex assessment of dysfunction of the neuro-physiological and psycho-physiological statuses; to use the innovative technologies of diagnostics, treatment, rehabilitation in correction of the functional violations with taking in mind not only the nosologic group of disease, but by an individual approach.

scholarly journals Breast Cancer Type Classification Using Machine Learning

2021 ◽  
Vol 11 (2) ◽  
pp. 61
Author(s):  
Jiande Wu ◽  
Chindo Hicks
Keyword(s):  
Breast Cancer ◽  
Gene Expression ◽  
Machine Learning ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Genomic Research ◽  
Support Vector ◽  
Cancer Type ◽  
Classification Models

Background: Breast cancer is a heterogeneous disease defined by molecular types and subtypes. Advances in genomic research have enabled use of precision medicine in clinical management of breast cancer. A critical unmet medical need is distinguishing triple negative breast cancer, the most aggressive and lethal form of breast cancer, from non-triple negative breast cancer. Here we propose use of a machine learning (ML) approach for classification of triple negative breast cancer and non-triple negative breast cancer patients using gene expression data. Methods: We performed analysis of RNA-Sequence data from 110 triple negative and 992 non-triple negative breast cancer tumor samples from The Cancer Genome Atlas to select the features (genes) used in the development and validation of the classification models. We evaluated four different classification models including Support Vector Machines, K-nearest neighbor, Naïve Bayes and Decision tree using features selected at different threshold levels to train the models for classifying the two types of breast cancer. For performance evaluation and validation, the proposed methods were applied to independent gene expression datasets. Results: Among the four ML algorithms evaluated, the Support Vector Machine algorithm was able to classify breast cancer more accurately into triple negative and non-triple negative breast cancer and had less misclassification errors than the other three algorithms evaluated. Conclusions: The prediction results show that ML algorithms are efficient and can be used for classification of breast cancer into triple negative and non-triple negative breast cancer types.

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