Medical Ethics

ISSN Print 2713-0894 ISSN Online 2713-0908

BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN

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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 383

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 375

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 366

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 388

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

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VIEWS 380

The term ‘bioethics’ (in the narrow sense) or ‘biomedical ethics’ denotes medical ethics at the modern stage of development. Bioethics is currently institutionalized and falls under the responsibility of specialized organizational structures (bioethics commissions, ‘divine committees’, etc.). The article expounds the prospects of applying network structures to institutions and organizations dealing with bioethical issues and tasks (ethical aspects of reproductive technologies, biomedical experiments, organ transplantation, and bioethical education). With the principles of decentralization (‘multiple authority’) and ecology (an integrative approach to issues under study and integrity of a bioethical expert team), network structures promote creative and effective functioning of bioethical organizations. Nonetheless, the centralized hierarchies of traditional educational and research institutions are also expected to perform essential functions. A reasonable combination of network structures and hierarchies provides the latter with a new role: the hierarchies assess the activity of emergent network structures using competent experts and provide selective support (including financing) to the most effective among them.

Received: 2023-08-06

Published online: 2023-10-04

DOI: 10.24075/medet.2023.024

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VIEWS 433

A new approach to medical ethics when it is interpreted as an applied theory of development has been investigated in this article. Relying on the ideas of German classical philosophy and Russian philosophy of unitotality, the development is defined based on the idea of any system as a set of basic polarities (thesis and antithesis). Their composition expresses deep polar definitions of the system and its polar portrait. A simulation model of this methodology is suggested using vector spaces with a scalar product. The development measure is introduced using the basis, the development law is defined, polar portraits of health and diseases are determined, the highest moral law is formulated as the law of development in the ethical sphere. To display medical ethics as an applied theory of development, three standards of classical medical ethics such as standards of mercy, ‘no harm’ and medical secrecy are analyzed, their polar interpretation is performed taking into account the suggested models. It is also displayed that all these standards express specific cases of the development law. Hypothesis of medical ethics as an applied section of development theory is supported, and a new research program of similar reinterpretation of other standards of medical ethics is suggested.

Received: 2023-08-10

Published online: 2023-09-25

DOI: 10.24075/medet.2023.023

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VIEWS 440

Mikhel DV, Mikhel IV

Bioethics, which addresses the pressing humanitarian issues, is an essential element of modern medical education. Transplant tourism is definitely one of these issues. Going abroad to resolve health problems, receive organs and have surgeries might be a growing trend for some Russians. The objective preconditions include deficiency of donor organs and inability of the healthcare system to satisfy the requirements of all those in need. Asia (India and China) has been the major destination of transplant tourism lately. However, things are changing, as Asian authorities attempt to eliminate the unwelcome trend. Russian citizens who go abroad as transplant tourists come across various risks including medical and ethical aspects.

Received: 2023-08-15

Published online: 2023-09-22

DOI: 10.24075/medet.2023.022

Comments 0

VIEWS 449