Medical Ethics

ISSN Print 2713-0894 ISSN Online 2713-0908

BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN

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The early XXI century was marked with entry into the market of a great deal of medicinal preparations with a totally new molecular-oriented mechanism of action. These results could only be made possible through achievements in molecular and cellular biology and completion of the Human Genome Project, in particular. Many pathogenic mechanisms of different illnesses, including oncological and autoimmune ones, were deciphered. The data stimulated the search for totally innovative therapy methods targeting at the key links of the abnormal process pathogenetic chain, collectively known as ‘targeted therapy’. The issues of personalized medicine, including the ethics, are considered through the study of the Coriell Institute.

Received: 2022-04-23

Published online: 2022-06-30

DOI: 10.24075/medet.2022.047

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VIEWS 577

In the last 20 years, epigenetics has evolved into a relevant and rapidly growing area of science. Scientific achievements in this area stirred interest among representatives of numerous socio-humanitarian disciplines, creating discussions at the legal, philosophical, political, social, cultural, medical, commercial and other levels. Thus, epigenetics is an outstanding example of a modern trend towards interdisciplinary trials as it is becoming a ‘borderline object’ of different sciences. In this article, the author analyzes the unfolding discussions regarding assessment of ethical, social and legal effects of epigenetics. Representation of epigenetics in mass media and science has been considered. Particular attention has been given to the reasons for epigenetic antideterminism. The epistemic value of epigenetics offers a different perception of some fundamental concerns such as the nature-upbringingnurture dichotomy, appropriate social politics, in particular, in the area of health, ethical contradictions when assessing harm and benefit, collective and individual responsibility (especially parental one), and the issue of non-identity. The author notes that in spite of the potential of epigenetics in personalized medicine, the exceptional phenomenon of epigenetics should be treated with caution due to early stages of the research and insufficiency of empirical data. Unreasonable extrapolation of epigenetic regulation to the sociocultural life can result in false reductionist conclusions. Nevertheless, the author is quite optimistic about the perspectives of epigenetic studies.

Received: 2022-04-25

Published online: 2022-06-30

DOI: 10.24075/medet.2022.050

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VIEWS 645

Przhilenskiy VI

Although legal regulation of genetic research has been steadily improved, it is still lagging behind promotion of genetic research, especially in the field of development and use of its achievement-based technologies. A distinct feature of this legal area is currently a higher dependence on ethics. This resulted in establishment of a special institution, an ethics committee, that unites the possibilities of ethical and legal expertise giving birth to numerous organizational and substantive issues. Some of them are reflected in discussions about the relationship between moral reflection and legislative processes, epidemiological status of bioethics, etc. For instance, in Russian literature there is a thesis that organization and conduction of ethical expertise is regulated much better than those of legal one and can be implemented within the current legal and regulatory framework. Meanwhile, a need for legal expertise in genomic research and genetic technologies is not inferior but even superior. This is confirmed by deficient legal support of many important decisions taken by the authorities and actions accomplished by research groups. The article reviews opinions of Russian and foreign scientists who provide different assessment of the role of ethics committees and their possible falling within law or ethics. The role and place of ethics committees in the system of rule-making harmonization and law enforcement are specified.

Received: 2022-04-22

Published online: 2022-06-30

DOI: 10.24075/medet.2022.043

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VIEWS 716

Abramova AV, Abramova VO

Further development of genetic engineering improved the chances to defeat deadly disorders due to discovery of innovative methods of treatment of various diseases, including oncological ones. In doing so, the methods have to go through clinical trials; they are not safe today. In fact, a paradox emerges: the trials are necessary, but they can’t be approved in accordance with regulatory requirements, as the risk for the subjects is higher than the benefit. For oncological patients, clinical trials, however, are the last chance for salvation. This requires an additional ethical discussion regarding approval of ethical expertise by the corresponding authorities in these exceptional cases. In this regard, the author of the article provides an ethical assessment of human genome editing applications from the point of view of risk and benefit for a subject and community of subjects, taking into account such ethical principles as ‘human priority’, ‘precautionary principle’ and ‘principle of responsibility to future generations’.

Received: 2022-04-24

Published online: 2022-06-30

DOI: 10.24075/medet.2022.049

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VIEWS 651

Continuous development of social relations implies the need in constant improvement of primarily legislative regulation so that it could adapt to the current realities in the society and country. This assumption is true both with regard to the legal regulation of the status given to participants of genomic research, as this relatively new area of social relations embraces both public, and private interests. In this respect, legal regulation should consider certain principles such as the balance of public and private interests, protection of human rights and freedoms, protection of sensitive data by the law, protection of the national interests, etc. Nevertheless, normative legal regulation of the status of genomic research participants in the Russian Federation is not complex in nature yet. Thus, it fails to result in development of this area of social relations and ensuring the rights, freedoms and legitimate interests of the mentioned persons. It is necessary to settle the issue about the boundaries of the allowed behavior, rights, obligations, guarantees and liability of genetic research participants. It seems to be appropriate to develop a complex federal law about the legal status of genetic research participants in the Russian Federation. A general approach to arranging complex legal regulation in this field consists in systematization of the existing legal regulation considering legislative regulatory activity of the discovered issues in the field of using genetic technologies and conducting genome research. During the regulatory control, it is necessary to reflect common moral and ethical principles and standards of medical and genetic research.

Received: 2022-04-22

Published online: 2022-06-30

DOI: 10.24075/medet.2022.046

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VIEWS 707

Sinitsina II, Nenascheva NM, Peredelskaya MYu, Sosin DN

While obtaining voluntary informed consent from patients with chronic obstructive pulmonary disease (COPD), bronchial asthma and patients presenting with psychiatric symptomology who participate in clinical trials, it is necessary to remember not only about the rights and ethical standards, but also about an extremely vulnerable position of the participants due to their disease specificity. Changes in the mental status of the patients and principal problems of every patient need to be considered. In this article, the aspects of obtaining informed consent from patients with respiratory diseases such as bronchial asthma and COPD and those under psychiatric supervision are reviewed. Apart from general recommendations, every category of patients has its own specific features. Being aware of them will improve doctor-patient communication.

Received: 2022-01-22

Published online: 2022-03-30

DOI: 10.24075/medet.2022.042

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VIEWS 667

Oxyethylammonium methylphenoxyacetate is an adaptogenic immunomodulator with a complex mechanism of action. It can be successfully used for treatment, prevention and restoration in case of flu and cold, and to improve working capacity in asthenia, including conditions developed following COVID‑19. Clinical investigation of the effect produced by oxyethylammonium methylphenoxyacetate demonstrates its effectiveness under extreme climate and geographic conditions, during physical and mental overload, exercise, viral infections, severe infectious pathology, and all diseases associated with a weakened immune system. Based on conducted clinical trials of oxyethylammonium methylphenoxyacetate, no adverse effects were found and good tolerability was observed. Due to good compatibility of oxyethylammonium methylphenoxyacetate with other agents, it can be included into complex rehabilitation programs as an independent or/and complementary agent. This increases effectiveness of the conducted treatment and improves the diagnosis.

Received: 2022-01-23

Published online: 2022-03-30

DOI: 10.24075/medet.2022.041

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VIEWS 818

Khokholov AL, Belousov DYu

Scientific development of 3D bioprinting is rapidly advancing. Bioprinting is expected to be actively implemented within the healthcare industry producing a revolutionary impact on transplantation. However, the innovative biotechnology involves numerous ethical and regulatory issues. Special attention is given to ethical issues associated with the use of embryonic cells, storage of personal data, obtaining informed consent, and peculiarities of clinical trials. The issues of safety and quality are reviewed. Equal access to technologies and use of biotechnologies to ‘enhance a human being’ are addressed. The issues of culture and religion are separately discussed within the context of this technology. It is stressed that as far as the issue of ethical estimation and legal regulation goes, 3D bioprinting can’t be completely assessed with the help of regular clinical trials or acting regulatory requirements. In particular, no suitable regulatory system or special documents regulating 3D bioprinting of tissues and organs and their subsequent transplantation are currently available in Russia or globally. Thus, it’s necessary to develop requirements to safety, quality and effectiveness of technological processes and end products obtained with the help of 3D bioprinting with the best interests of generally acknowledged human rights.

Received: 2022-01-20

Published online: 2022-03-30

DOI: 10.24075/medet.2022.040

Comments 0

VIEWS 887