Medical Ethics

ISSN Print 2713-0894 ISSN Online 2713-0908

BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN

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Ruda MG

The article deals with legal and ethical issues of establishing the boundaries of informed consent as a basic procedure being an integral part of medical practice, biomedical and clinical human research, and a broad list of medical procedures. A comparative analysis was based on examination of the best global models of informed consent. In the future, their implementation into the Russian legislative and regulatory compliance practices is suggested. The research uses the following methods: analysis and synthesis, analogy, method of legal modelling, and method of comparative legal research. Some conclusions were made about the reception of certain legal issues considering such factors as legal mental structure, level of legal culture, etc. In this article, the following aspects are highlighted: requirement for information disclosure, requirement to understand the relationship, a researcher’s liability to enhance qualifications, a patient’s responsibility, and the issue about an informed consent form.

Received: 2022-04-20

Published online: 2022-06-30

DOI: 10.24075/medet.2022.044

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VIEWS 1073

Bogomiagkova ES

The article contains the results obtained during an empirical study of health care practices among people of a large Russian city implemented in a combined strategy in 2020–2021. Our focus remains on the reference of citizens to the procedure of DNA diagnostics as a novel instrument of health-saving behavior and attitude to genetic knowledge in general. The obtained data allow concluding that genetic testing is not widely popular among population today, as only 9,5% of those interviewed have ever done it. DNA diagnostics is more frequently used by young women and men with high income and don’t trusting modern medicine, which probably reflects the actual condition of the market of genetic services in our country. Apart from financial possibilities, involvement into consumer genomics is influenced by insufficient trust in DNA information, and suspecting that players on the market of genetic services obtain economic profit. However, the most important argument against it consists in the discovered discrepancy between perception of genetic data as something inevitable and currently popular ideology of healthy lifestyle, meaning that a person can influence the outcome of the efforts made. As a result, research participants are not willing to become the everlasting ‘patients-in-waiting’ even in case of existing symptoms, but implement their ‘right not to know’. Under these conditions, an important task includes organization of active promoting awareness that unlocks potential, capabilities and limitations of genetic diagnostics.

Received: 2022-04-24

Published online: 2022-06-30

DOI: 10.24075/medet.2022.045

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VIEWS 1018

The article deals with aspects of legal regulation of human (somatic, germline, heritable) gene editing techniques. Principal risks and problems of implementing these techniques in clinical practice are mentioned. The experience of using the techniques of genome editing and recommendations of WHO 2022 are analyzed. Special attention is paid to conflicts of interests and conflicts of liabilities while creating the concept of legal regulation of genome editing in humans. The conclusions are drawn concerning the necessary disclosure of data about the conducted research and results obtained globally to create the principles and standards of legal regulation of genome editing in humans. In spite of the existing controversies between the scientific communities and countries, it is extremely important to promote an international dialogue, as human genome editing concerns everyone and future generations, variety of human community and safe life and health.

Received: 2022-04-21

Published online: 2022-06-30

DOI: 10.24075/medet.2022.048

Comments 0

VIEWS 1233

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

Comments 0

VIEWS 1060

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

Comments 0

VIEWS 1073

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 1139

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

Comments 0

VIEWS 1114

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

Comments 0

VIEWS 1115