scholarly journals Peculiarities of Legal Regulation of the Use of Genomic Technologies in Embryology and Artificial Fertilization in the UK

Lex Russica ◽  
2020 ◽  
pp. 39-46
Author(s):  
S. A. Vasiliev ◽  
S. Kh. Sarmanaev ◽  
S. S. Zenin ◽  
A. Yu. Shirokov
Keyword(s):  
Legal Regulation ◽  
Modern Medicine ◽  
Genomic Research ◽  
High Tech ◽  
Human Fertilisation ◽  
Genomic Technologies ◽  
Human Fertilization ◽  
Artificial Fertilization ◽  
Genomic Editing ◽  
The Uk

The development of modern medicine is based on the development of high-tech treatment methods. One of such methods includes the application of genomic research that in Russia is not inferior, but in many ways superior to the achievements of Western scientists. However, legal regulation, or rather lack of such regulation in our state prevents comprehensive application of advanced techniques in practice. In order to solve this issue, it becomes relevant to study the experience of foreign countries in order to take into account their flaws and gaps in legal regulation to deal with the debate over problems that may be associated with the application of advanced techniques. The paper considers the use of genomic technologies in the UK in the field of embryology and artificial fertilization as one of the most open areas for genomic editing in modern medicine. The paper elucidates the issue of obtaining and withdrawal (revoking or suspending) of the license by organizations that provide medical services in the field of embryology and artificial human fertilization. The authors also deal with the issue of the formation of specialized bodies, e.g. appeals committees in the Human Fertilisation and Embryology Department, dealing with narrow issues. The authors have chosen legal regulation of the issue under consideration in Britain because it appears to be the most liberal regulation as compared with the regulation applied in the other States and even under international law. This, in turn, creates grounds for fears, disputes and discussions in the expert community, which is also of particular interest to the forthcoming Russian law-making and law enforcement. For the purposes of the study, the authors analyze the provisions of the Human Fertilisation and Embryology Act in terms of their applicability both in the UK and in Russia and examine expert opinions regarding the issues under consideration. Based on the work done, the authors propose to implement the model of legal regulation under which both children who appeared as a result of genomic editing and donors are to be informed of the application of this method.

scholarly journals THE RISKS OF IMPLEMENTING GENOMIC RESEARCH PROGRAMMES IN THE RUSSIAN FEDERATION

2018 ◽  
Vol 4 (2) ◽  
pp. 84-94
Author(s):  
A. N. Petrov  ◽  
N. G. Kurakova
Keyword(s):  
Genome Editing ◽  
Russian Federation ◽  
Technological Development ◽  
Legal Regulation ◽  
Genomic Research ◽  
High Tech ◽  
Full Life Cycle ◽  
Genomic Technologies ◽  
Research Programmes ◽  
The Russian Federation

In order to implement The strategy of scientific and technological development of the Russian Federation, the state program of genomic research and the complex scientific and technological program “Postgenomic technologies: from genetic editing to synthetic biology” are planned to be implemented in the country. Noting the obvious prospects and expediency of the development of post-genome editing technologies and high-tech industries based on them, the authors of the article highlight the barriers and risks of the full life cycle projects: the lack of sufficient number of personnel, the low level of competitiveness of domestic scientific and technological reserves, the lack of modern instrumentation, the lack of industrial partners, as well as the problems of normative and legal regulation of genetic engineering activities in the Russian Federation. Made in the framework of the study the analysis of global competitive landscape in the technology of genome editing showed that by 2018, several multinational companies have established a strong portfolio of patent documents as a tool for the conquest of leading positions in the markets generated by the post-genomic technologies.

scholarly journals Privacy, anonymity and subjectivity in genomic research

2016 ◽  
Vol 98 ◽  
Author(s):  
IAN MCGONIGLE ◽  
NOAM SHOMRON
Keyword(s):  
International Law ◽  
Personal Data ◽  
Genetic Data ◽  
Genomic Research ◽  
Genome Data ◽  
Genomic Technologies ◽  
Biology Organization ◽  
Human Genome Data ◽  
European Molecular Biology Organization ◽  
Special Meeting

SummaryThe use of non-anonymized human genome data is becoming increasingly popular in research. Here we review the proceedings of a special meeting on this topic that took place at European Molecular Biology Organization (EMBO) in December 2014. The main points discussed centered on how to achieve ‘anonymity,’ ‘trust,’ and ‘protection of data’ in relation to new genomic technologies and research. Following our report of this meeting, we also raise three further issues for future consideration: the harmonization of international law in relation to genetic data protection; the complex issues around the ‘dividual’ nature of genetic data; and the growing commercial value of personal data. In conclusion, we stress the importance of scientists working in the area of genomic research engaging in interdisciplinary collaborations with humanities and social science scholars and addressing these complicated issues.

The development of complications of community-acquired pneumonia of a severe course against the background of parenteral poisoning with a mixture of narcotic substances

2020 ◽  
Vol 22 (4) ◽  
pp. 59-66
Author(s):  
I. N. Gayvoronskiy ◽  
Yu. Sh Khalimov ◽  
S. V. Gayduk ◽  
T. V. Lyanginen ◽  
A. S. Partsernyak ◽  
...  
Keyword(s):  
Young Patient ◽  
Severe Pneumonia ◽  
Modern Medicine ◽  
Multiple Organ ◽  
Community Acquired Pneumonia ◽  
High Tech ◽  
Antibacterial Drug ◽  
Toxic Substances ◽  
Military Medical Academy ◽  
Vital Functions

Doctors of the clinic of military field therapy of the Military Medical Academy named after S.M. Kirov, the experience of successful treatment of community-acquired pneumonia of a severe course with the development of complications against the background of parenteral poisoning with a mixture of narcotic substances in a young patient was obtained. An important feature in the treatment tactics of this patient was the impossibility of antidote therapy with naloxone (a competitive opioid receptor antagonist) due to the presence of signs of respiratory failure, hypoxic and tissue hypoxia. As a result of the systemic treatment in the young patient, it was possible to arrest a significant septic process and multiple organ disorders of vital functions that arose due to severe endotoxic damage. An important factor in ensuring the survival of patients with severe pneumonia against a background of immune depression due to the use of toxic substances is the rational selection of an antibacterial drug or combinations of antibiotic therapy, constant monitoring of vital functions with prompt correction of emerging disorders, as well as the need to use modern high-tech treatment methods. This example clearly shows the need for urgent, systematic and complex intensive care in a number of manipulations performed in people with complications of community-acquired pneumonia, suffering from drug addiction. In addition, it is important to minimize the time from the detection of a poisoned person to the start of emergency measures, as well as their further evacuation to the stage of providing qualified and specialized medical care. Thus, modern medicine continues to face an extremely urgent problem of drug use by the population. A significant number of people with drug dependence syndrome do not seek medical help for various reasons, continuing to use illegal drugs.

A lack of foresight? Jurisdictional uncertainties in the regulatory interface between the HFEA, the UK Stem Cell Bank and beyond

Legal Studies ◽  
2007 ◽  
Vol 27 (3) ◽  
pp. 511-535 ◽  
Author(s):  
Ryan Morgan
Keyword(s):  
Embryonic Stem ◽  
Embryo Research ◽  
Es Cell ◽  
Statutory Interpretation ◽  
Cell Bank ◽  
Human Fertilisation ◽  
Department Of Health ◽  
Regulatory Architecture ◽  
Policy Objectives ◽  
The Uk

Much of the legal attention surrounding human embryonic stem (ES) cell research within the UK has, to date, focused on cloning techniques. Whilst this is both understandable and appropriate given litigation on this topic, there has been less focus on other areas. This paper identifies and analyses areas of incoherence and deficiency within the regulatory architecture governing human ES cell derivation and research within the UK. This is not merely a theoretical exercise, as there are indications that many of the policy objectives currently being pursued in this area have, at best, a shaky jurisdictional basis. It is all too easy to recall that lobby groups have challenged the Human Fertilisation and Embryology Act 1990, the legislative foundation for embryo research and most infertility treatment, on the basis of jurisdictional uncertainty and statutory interpretation. Whilst many pro-life campaigners are opposed to ES cell research on ethical grounds, the arguments utilised thus far in relation to litigation have been entirely legal, involving issues of statutory interpretation and whether the regulator, the Human Fertilisation and Embryology Authority (HFEA), or the Department of Health have acted ultra vires the 1990 Act. This paper will reveal that there are a number of further areas which might be open to attack on this basis.

scholarly journals High-Tech Equipment for Moxibustion in Modern Medicine

10.5772/53802 ◽  
2013 ◽  
Author(s):  
Takashi Seki ◽  
Junnosuke Okajima ◽  
Akiko Kikuchi ◽  
Shin Takayama ◽  
Masashi Watanabe ◽  
...  
Keyword(s):  
Modern Medicine ◽  
High Tech

scholarly journals FDA oversight of NSIGHT genomic research: the need for an integrated systems approach to regulation

2019 ◽  
Author(s):  
Laura V. Milko ◽  
Flavia Chen ◽  
Kee Chan ◽  
Amy M. Brower ◽  
Pankaj B. Agrawal ◽  
...  
Keyword(s):  
Clinical Research ◽  
Systems Approach ◽  
Genomic Sequence ◽  
Clinical Investigation ◽  
Risk Assessments ◽  
Genomic Research ◽  
Institutional Review Boards ◽  
Sequence Information ◽  
Genomic Technologies ◽  
Challenges And Opportunities

ABSTRACTThe National Institutes of Health (NIH) funded the Newborn Sequencing In Genomic medicine and public HealTh (NSIGHT) Consortium to investigate the implications, challenges and opportunities associated with the possible use of genomic sequence information in the newborn period. Following announcement of the NSIGHT awardees in 2013, the Food and Drug Administration (FDA) contacted investigators and requested that pre-submissions to investigational device exemptions (IDE) be submitted for the use of genomic sequencing under Title 21 of the Code of Federal Regulations (21 CFR) part 812. IDE regulation permits clinical investigation of medical devices that have not been approved by the FDA. To our knowledge, this marked the first time the FDA determined that NIH-funded clinical genomic research projects are subject to IDE regulation. Here we review the history of and rationale behind FDA oversight of clinical research and the NSIGHT Consortium’s experiences in navigating the IDE process. Overall, NSIGHT investigators found that FDA’s application of existing IDE regulations and medical device definitions aligned imprecisely with the aims of publicly funded exploratory clinical research protocols. IDE risk assessments by the FDA were similar to, but distinct from, protocol risk assessments conducted by local Institutional Review Boards (IRBs), and had the potential to reflect novel oversight of emerging genomic technologies. However, the pre-IDE and IDE process delayed the start of NSIGHT research studies by an average of 10 months, and significantly limited the scope of investigation in two of the four NIH approved projects. Based on the experience of the NSIGHT Consortium, we conclude that policies and practices governing the development and use of novel genomic technologies in clinical research urgently need clarification in order to mitigate potentially conflicting or redundant oversight by IRBs, NIH, FDA, and state authorities.

scholarly journals The Peculiarities of Civil-Legal Regulation of Transplantation in Ukraine and Europe

2018 ◽  
Vol 8 (1) ◽  
pp. 33-48
Author(s):  
Alla Herts
Keyword(s):  
Treatment Process ◽  
Developed Countries ◽  
Legal Regulation ◽  
Modern Medicine ◽  
The Body ◽  
Accessibility Of Health Services ◽  
Surgical Field ◽  
Processed Form ◽  
The Cost ◽  
Cadaveric Transplantation

Abstract In modern realities the issue of the quality and accessibility of health services, the cost of medicines, examinations and treatment in general is being increasingly frequently discussed. The attention is focused on such a narrow surgical field as transplantation, because in Ukraine thousands of patients are waiting in line for organ transplantation and very few operations are performed. The main, most secure and common type of transplantation is the transplantation of organs and tissues from a deceased person, the dead body. Cadaveric transplantation, which is used in most developed countries, is hardly carried out in Ukraine. This is due to the fact that the current regulatory base of Ukraine in the field of transplantation does not fully meet the needs of modern medicine and has many gaps. The aim of donation is a future transplantation (including and in cases of blood transfusion and reproductive cells use). The parts (tissues, organs, their parts, individual cells) extracted (separated) from the body in the process of donation can be used generally in the treatment process in a processed form (blood plasma) or in the original state (fertilized reproductive cells). The detailed analysis of the provisions of the national legal system makes it possible to conclude that, despite the absence of direct regulation of relations concerning organ donation and transplantation as material relations, the legal regulations provide the fundamental provisions, which determine their material nature, and therefore offer opportunities for agreementbased regulation. In our opinion, one of the essential legal means of ensuring the rights of participants in the relations of donation and transplantation can be their agreement-based regulation. The peculiarities of civil-legal regulation of transplantation in Ukraine and Europe are simultaneously analysed; and the grounds of its legitimacy are defined.

scholarly journals About Formation of International Ethical Digital Environment with Smart Artificial Intelligence

2021 ◽  
Vol 11 (1) ◽  
pp. 1-9
Author(s):  
Evgeny Bryndin
Keyword(s):  
Artificial Intelligence ◽  
Intelligent Agents ◽  
Legal Regulation ◽  
Ethical Standard ◽  
High Tech ◽  
Digital Environment ◽  
Widespread Application ◽  
Social Sphere ◽  
The Social ◽  
Cognitive Robots

Intellectual agent ensembles allow you to create digital environment by professional images with language, behavioral and active communications, when images and communications are implemented by agents with smart artificial intelligence. Through language, behavioral and active communications, intellectual agents implement collective activities. The ethical standard through intelligent agents allows you to regulate the safe use of ensembles made of robots and digital doubles with creative communication artificial intelligence in the social sphere, industry and other professional fields. The use of intelligent agents with smart artificial intelligence requires responsibility from the developer and owner for harming others. If harm to others occurred due to the mistakes of the developer, then he bears responsibility and costs. If the damage to others occurred due to the fault of the owner due to non-compliance with the terms of use, then he bears responsibility and costs. Ethical standard and legal regulation help intellectual agents with intelligent artificial intelligence become professional members of society. Ensembles of intelligent agents ith smart artificial intelligence will be able to safely work with society as professional images with skills, knowledge and competencies, implemented in the form of retrained digital twins and cognitive robots that interact through language, behavioral and active ethical communications. Cognitive robots and digital doubles through self-developing ensembles of intelligent agents with synergistic interaction and intelligent artificial intelligence can master various high-tech professions and competencies. Their use in the industry increases labor productivity and economic efficiency of production. Their application in the social sphere improves the quality of life of a person and society. Their widespread application requires compliance with an ethical standard so that their use does not cause harm. The introduction and use of an ethical standard for the use of cognitive robots and digital doubles with smart artificial intelligence increases the safety of their use. Ethical relationships between individuals and intellectual agents will also be governed by an ethical standard.

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