Medical Ethics

ISSN Print 2713-0894 ISSN Online 2713-0908

BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN

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Lileeva EG, Speshilova SA, Zinoveva MA

Alcohol currently contributes to 5% of the overall global burden of diseases and injuries. Alcohol consumption results in death and disability at young age. Medicinal products approved for treatment of alcohol dependence syndrome include disulfiram, Naltrexone, Cyanamid and nalmefene. Variability of a patient-to-patient pharmacotherapy therapeutic effect can also be associated with genetic causes. Examination of the system of pharmacogenetic markers in narcology will be used to provide for preliminary prognosis of effectiveness and tolerance of medicinal products during personalized anti-relapse (supporting) therapy to support and prolong remission in patients with alcohol dependence.

Received: 2023-10-13

Published online: 2023-12-21

DOI: 10.24075/medet.2023.032

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VIEWS 478

Borzova MA, Kalinichenko VV, Kolbin AS

The real-world data (RWD) constitute a modern trend in the healthcare system and in the structure of taking decisions. The trend is being actively developed in the Russian Federation. Ethical aspects of these trials and legal regulation of RWD are, however, still unresolved. In this paper, development of the legal field and national regulation of RWD in Russia is discussed during registration, assessment of healthcare technologies, management of patient registries, and development of clinical recommendations. It is shown that the acting regulatory field of the Russian Federation contains no bans on the use of RWD to support regulatory decisions. Nevertheless, the existing legal laws set limited opportunities for practical application and accounting of RWD by the competent authority. In conclusion, recommendations on further development of RWD legal field in Russia are provided.

Received: 2023-10-14

Published online: 2023-12-10

DOI: 10.24075/medet.2023.031

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VIEWS 633

The article provides answers to immediate questions associated with the state regulation of confidentiality of information and exchange of data in the era of digital healthcare. The institute of medical confidentiality which originated in the ancient world is still evolving throughout the development of medical law. In the current era of global digitalization, however, the issues related to data confidentiality have become more relevant than ever. With all the modern technologies and digital health care platforms on the rise, new challenges associated with protection of these patients are emerging. To ensure the reliable protection of patient’s personal and medical information, doctors and medical institutions have to meet data security standards. It becomes vital to develop effective strategies and mechanisms to prevent unauthorized access and data leakage due to a larger volume of electronic medical records and digital data exchange. Strict rules and standards regulating collection, storage and transfer of medical data belong to a key aspect in this area. The Russian Federation is making great efforts to create the legislation which could protect the rights of patients and made medical establishments to follow the high standards of confidentiality, and to develop technical aids that provide data encryption and protection against hacker attacks.

Received: 2023-10-14

Published online: 2023-12-06

DOI: 10.24075/medet.2023.030

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VIEWS 555

Оmelyanovskiy VV, Rukavitsyna NP, Mukhortova PA, Kingshott AA, Zinadinov SI, Kharitonova AG, Minakova EI, Krekhtunova LO, Barysheva VO

Timely accessibility of effective and safe medicinal products is one of the main tasks of healthcare. The goal of the present review is to assess various approaches that provide an early access to medicinal products within the BRICS group (list of participants as of 01.10.2023), European Union and United States of America. The stage of the life cycle of medicinal products is closely associated with their further movement in the market, patient access rate, and partially with the issues of their financing and reimbursement, which directly influence their affordability for population. The article contains data about the specifics of expanded access to unregistered medicinal products used on a compassionate basis and presenting therapy under early access programs financed by pharmaceutical companies; it also describes approaches to accelerated registration and registration of medicinal products in case of limited clinical data. Experience of the reviewed countries in early access programs is described.

Received: 2023-10-31

Published online: 2023-11-27

DOI: 10.24075/medet.2023.029

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VIEWS 613

Deeva VA, Guseva EV, Demуanov VS, Isaeva PA, Polushkina MA, Ruck DM, Tihonova AS, Kim TG

The article is devoted to ethical aspects of bedside training. Education of future specialists in the clinical setting is important to acquire knowledge, skills, professional competencies and to form clinical thinking. Transfer of professional medical experience occurs simultaneous to the development of communication skills which are required to deal with patients, their relatives, colleagues and mentors. It is about comprehension of how the normal standards of medical deontology are implemented in real practice and how important the effective therapeutic alliance is while interacting with the patient. Though bedside training is a long-standing tradition of medical education, the origins of which are associated with the Ancient Greek Healing Practices, it is not always understood and supported by patients and their relatives, and requires students to get more familiar with ethical standards regulating similar education and their behavior within a medical group and institution.

Received: 2023-10-31

Published online: 2023-11-23

DOI: 10.24075/medet.2023.028

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VIEWS 555

The article sums up the pros and cons regarding the animal models selected and critically explored by Cameron Shelley in the article entitled ‘Why test animals to treat humans? On the validity of animal models’. Special attention is given to the adaptation of the topic-related English version of this discourse for a Russian-speaking reader. Arguments of supporters and opponents of animal models provided by C. Shelley are reviewed. The issue of the effective use of animals in biomedical research considering the validity criterion is being discussed. The connection between the validity and morality of an animal model suggested by C. Shelley is further elaborated. According to C. Shelley, out of three critical arguments for animal modeling, the pseudoscience argument and the disanalogy argument do not work, as the pressing issues they raise are interpreted by supporters in the wrong way. The predictive validity argument is not sufficient, as the doubts raised about the predictive power of animal models are either not supported or lack clear formulation. C. Shelley states that assessing the validity of an animal model is a complex task, which includes various approaches to determining the extent of model validity as appropriate, and defines the problem as an issue of determining the type of validity and its effect on the assessed morality of an animal model. According to the author, ethical issues come down to pragmatics of validity as a criterion capable of disorientating critics of animal modeling or at least reconciling them with the necessity and inevitability of animal experiments.

Received: 2023-08-21

Published online: 2023-11-20

DOI: 10.24075/medet.2023.026

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VIEWS 560

Khokholov AL, Zhbannikov PS, Zarov AYu, Firsov DE, Shkurankov AV, Makarov SV

In the modern world, traditions of social work are highly demanded both by the professional medical corporation and entire society. The experience of hospital volunteering is particularly relevant in relation to palliative patients. Volunteers involved in practical healthcare should have the corresponding level of qualification. The issue is solved by training and retraining of hospital volunteers and specialists of various levels at medical educational institutions. Junior medical nurses (sisters of mercy) have been trained at the Yaroslavl State Medical University since 2023. The specialized department of palliative medicine on the basis of Clinical Central Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church was created at the Yaroslavl State Medical University. It is the interaction with state, social and confessional structures that allows to solve issues of practical implementation of the skills obtained by volunteers considering a wide range of community demands.

Received: 2023-10-06

Published online: 2023-11-20

DOI: 10.24075/medet.2023.027

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VIEWS 600

Lutsevich KA, Ryzhenkova IG, Reshetko OV

The article deals with the need of compulsory participation of pregnant women in clinical research of drugs. By the beginning of the 90‑s of the last century, the majority of drugs prescribed to women was characterized by unsubstantial evidence of effectiveness and safety for women. Moreover, pregnant women almost did not participate in clinical research. Though pregnancy is a dynamic condition that can be compared with itself only. Then supervisory bodies created some documents regulating compulsory participation of the population in the research of drugs. However, until now, women are not sufficiently involved in the research of new original drugs, and pregnant women do the same very rarely. Possible scenarios of participation of pregnant women in clinical research have been reviewed. In particular, research of drugs used in therapy of abnormal conditions associated with pregnancy; drugs to treat chronic and acute pathological processes not related to pregnancy, and when a woman gets pregnant during the research have been distinguished. The importance of inclusion of pregnant women into the trials of effectiveness and safety of drugs in the presence of socially significant diseases, including the ones found during COVID‑19 pandemics, is postulated.

Received: 2023-06-21

Published online: 2023-10-10

DOI: 10.24075/medet.2023.025

Comments 0

VIEWS 606