Opinion Amendments and additions to the World Medical Association declaration of Helsinki “Ethical principles for medical research involving human participants” [1]
Khokholov AL, Firsov DE, Sopetina DN
The current version of the Declaration of Helsinki, adopted at the 75th General Assembly of the World Medical Association in October 2024, represents a significant step forward in the updating one of the basic international documents defining fundamental approaches to regulating medical research involving humans. The amendments and additions to the Declaration reflect the task of ensuring compliance of ethical principles of medical research with real research practice. For 60 years, the Declaration of Helsinki has maintained its importance as an ethical guide upholding the humanistic principles of medical research, motivating the professional medical community to cooperate and consolidate in the prevention of risks to humans, following the interests of science and society.
Received: 2025-01-27
Published online: 2025-03-13
DOI: 10.24075/medet.2025.002
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VIEWS 813
Original research Non-specific prevention of novel coronavirus infection in the workplace as a component of medical deontology
Medvedeva EA, Marin GG, Chernogorova MV, Bakhareva IR
One of the important factors of medical deontology is the focus of a healthcare professional on the health of patients and colleagues in case of increased infectious morbidity within the framework of limiting transmission of an infectious agent. The aim of the study was to assess the true frequency of regulated use of PPE, including in the provision of medical care to patients with COVID-19, and compliance with the isolation regimen in case of respiratory illness among health workers. The study was conducted using the Internet (the questionnaire is posted on ancetolog.ru) from January to March 2022 (ongoing COVID-19 pandemic). Survey data of 3,570 respondents was analyzed in accordance with the quality criteria for filling out the questionnaires. The overwhelming majority of the respondents were women, 63.6% (2,269 people) and 36.4% (1,299 people) were men, the average age of the respondents was 38.9 ± 14.22 years. Non-compliance with the rules of wearing PPE was detected for every fourth respondent (24.9%), 4.1% refused to wear PPE, and 7% complied with the rules of wearing PPE in the workplace only when their non-compliance could be noticed. The data we have obtained indicates that a quarter of health workers do not follow professional ethics in the framework of preventive measures to reduce infectious diseases, threatening the health of colleagues and patients by their behavior in the workplace.
Received: 2024-12-20
Published online: 2025-03-05
DOI: 10.24075/medet.2025.001
Comments 0
VIEWS 729
Review Neuroethics in medicine. Pressing issues
Filatova YS, Zolotova IA
The article focuses on some aspects of neuroethics in medicine. Due to the continuous growth of research, new advances in neuroscience, and use of neurotechnology, ethical issues related to personality, autonomy and confidentiality may arise. The article addresses neuroethical issues of management of patients with various neurological diseases and special psychological conditions. The issue of using neuroethical aspects to solve issues in the field of diagnosis and treatment of disorders of consciousness is also discussed. Another important area of research that uses neuroethics is treatment of drug addiction, namely the ethical aspects of using neurotechnology. The authors conclude that the prospects for using neuroethics in medicine are very diverse. It underlines the importance of its studying at all stages of medical education, including secondary, higher and postgraduate ones.
Received: 2024-11-11
Published online: 2024-12-31
DOI: 10.24075/medet.2024.029
Comments 0
VIEWS 691
Review Evidence obtained during real world data analysis: what it is and how we form it
Verbitskaya EV, Kolbin AS
The article is devoted to the pressing issue of using real world data (RWD) to prove effectiveness and safety of medical technologies. The authors consider the advantages and limitations of this approach compared to traditional randomized clinical trials. According to the main provisions of the article, RWD complement the results of clinical trials and make it possible to evaluate the effectiveness of drugs in everyday practice. Key stages of conducting RWD-based research are described such as research design, selection and evaluation of data source quality, analytical methods, ensuring transparency and reproducibility. Modern tools for planning and conducting RWD research are presented, for example, the HARPER protocol template, structured SPACE approach, and SPIFD data assessment tool. The features and limitations of RWD are discussed, including their unstructured nature, omissions, and inconsistency. The importance of observing the principles of transparency, integrity, and minimizing systematic errors when working with RWD is emphasized. There is a growing recognition of RWD by regulatory authorities and a need to develop standardized approaches to obtain it. In conclusion, the authors emphasize that with proper application of the research methodology, RWD can provide valuable information for decision-making in healthcare, complementing traditional clinical trials.
Received: 2024-11-02
Published online: 2024-12-31
DOI: 10.24075/medet.2024.028
Comments 0
VIEWS 751
Original research Framework of risk evaluation of medical AI systems
Volskaya EA, Rogova IV
Medical technologies using artificial intelligence (AI) systems hold a firm place in real clinical practice as the main providers of important information for making medical decisions in diagnosis and treatment via assisting and auxiliary tools in the process of medical care provision. To obtain valid evidence of quality, effectiveness, and safety, AI software developers conduct clinical trials of these systems in accordance with current regulatory requirements [1], guided by the recommendations of recognized experts in the field of clinical research [2]. Ethical committees have a task to conduct a high-quality ethical review of the planned research, taking into account the specifics of AI technologies used in medicine and risks associated with their use.
Received: 2024-11-04
Published online: 2024-12-31
DOI: 10.24075/medet.2024.027
Comments 0
VIEWS 762
Opinion The role of Christian Ethics in shaping medical practice
Filkin AN, Kudrina SA
Religion, ethics and medicine are recognized to be related since antiquity. This article discusses the ethical aspect of medicine and focuses on the moral qualities of a doctor in the face of modern challenges. The main focus is on returning to traditional values based on Christian morality. The Bible changed the relationship between humanity and the Divine, when a man is viewed as an image of the Creator and the need for divine intervention in healing is emphasized. Unlike ancient rationalism, Christian faith is aware of the cognition limits and understands the importance of the spiritual aspect of health. The article analyzes how the Hippocratic oath has changed under the influence of Christian values. The importance of cooperation between doctors and priests who healed patients is considered, and the need for compassion in medical practice is emphasized. The synthesis of faith and medical science makes us understand that healing involves achieving both physical and mental, as well as spiritual well-being.
Received: 2024-10-28
Published online: 2024-12-31
DOI: 10.24075/medet.2024.026
Comments 0
VIEWS 774
Original research Ethical aspects of counseling people with mental disorders who are planning their pregnancy
Lobanova IV, Sataev AE, Manaeva TA
This article highlights the ethical aspects that arise when the attending psychiatrist communicates with patients and their family members on the issues of planning a pregnancy. While counseling people with mental disorders about their reproductive plans, it is difficult from an ethical point of view to discuss some issues such as the risks of pathology in an unborn child and a possibility of reducing the risks, in particular the probability of genetic inheritance of a mental disorder; the expediency of discontinuing psychotropic drugs used by the expectant mother and/or father to treat or prevent a mental disorder exacerbations, given that drugs can affect the quality of reproductive biological material, whereas cancellation of therapy is associated with risks to the mental health of expectant parents; the need to inform the patient’s family members about his/her mental disorder, the treatment used and all available personal risks to offspring. Different literature sources, including domestic and foreign ones, were reviewed. The keywords used in literature were “genetics”, “psychiatry”, “ethical aspects of genetic counseling”, “psychopharmacotherapy during pregnancy”, “the effect of psychotropic drugs on spermatogenesis” with filtering by language (Russian and English) and document type. Two own clinical observations are presented. The purpose of the article is a comprehensive analysis of ethical aspects of counseling people with mental disorders on pregnancy planning by a psychiatrist.
Received: 2024-11-13
Published online: 2024-12-24
DOI: 10.24075/medet.2024.025
Comments 0
VIEWS 739
Original research Ethical issues of neurotechnology
Firsov DE, Ivashkovskaya AV
Discussion of the draft of the Recommendations on the Ethics of Neurotechnology proposed by UNESCO reveals the need to develop domestic regulations in this area, taking into account modern challenges of technological development. The purpose of the recommendations in the field of neuroethics is to ensure the human right to protect health, well-being and dignity associated with the risks of technological interference in the brain and mental processes, as well as threats associated with the social and humanitarian consequences of scientific and technological progress in the field of neuroscience and neurotechnology. The draft of domestic recommendations should establish obligations related to the ethical aspects of creation, implementation and use of neurotechnologies, which are currently not regulated by the legislation of the Russian Federation and acts of technical regulation. The objectives of the recommendations are to specify the terminological apparatus in accordance with the current regulatory legal acts, targeted separation of neurotechnologies for medical and non-medical purposes, ensuring safety for the health and well-being of vulnerable persons and social groups. In the socioeconomic aspect, development of domestic recommendations on the use of neurotechnologies shows the relevance of stimulating development of domestic production and socioeconomic growth in accordance with the national development goals of the Russian Federation until 2030.
Received: 2024-11-02
Published online: 2024-12-21
DOI: 10.24075/medet.2024.024
Comments 0
VIEWS 865