Currently, systems based on artificial intelligence (AI) are finding increasing application in medicine. Acting as assistants of both the attending physician and managing physician, they can be a good help in solving a number of problems in modern healthcare, such as staff shortage, professional burnout and, in some cases, insufficient staff qualification. However, this leads to increased requirements for reliability of such systems. Introduction of a new advanced technology raises a number of ethical issues and problems, the solution of which is necessary to gain trust of people and reduce distrust associated with the use of AI technologies. It seems that if ethical standards determine and set the progressive development of artificial intelligence, this will lead to the maximum benefit from the use of this technology in healthcare. The paper examines the ethical aspects of transition of software into the category of medical devices. At the same time, legal and organizational mechanisms for solving ethical problems at both the international and domestic levels are provided. The activities of both public and government organizations in this field are considered. The need to obtain the permission of ethical committees for conducting clinical trials and ensuring informed consent of patients is emphasized. It also highlights the importance of integrating medical data into structured datasets that can be registered as databases. This will contribute to improved quality of medical research and practice.
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Today, the problems of moral education of future doctors are the most acute not only in the Kyrgyz Republic. The consciousness of the youth of the XXI century is sometimes formed in a non-linear way under the influence of pragmatism and utilitarianism. The organization of ethical and moral perception of the world and self-organization in the best positions of humanism is a problem not only of a theoretical but also of a practical nature. Methodological ideas and principles proposed by various researchers in the field of social sciences and humanities are mainly aimed at overcoming both all-encompassing relativism and fundamentalism. However, the way it should be implemented while teaching bioethics is a methodological problem, in particular in the Kyrgyz Republic. The purpose of our work is to consider various approaches in the context of development of our national paradigm of education in medical universities. Modern Kyrgyzstan needs efficient teaching methods, since only they can effectively form the main pillars of moral consciousness of students, which are necessary for implementing medical activities. The educational cornerstone is development of interactive discourse, not only as a comprehensive communication, but also as analysis of all the interacting factors of this process (determining the context, directly affecting the participants and their understanding of the world). The research uses methods of hermeneutics and comparative analysis. Pedagogical approaches and methods of use while teaching bioethics at universities are taken into consideration. Teachers of bioethics in medical institutions of Kyrgyzstan need to develop effective approaches and methods of teaching young people, such as interactive discourse and a dialectical method.
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The relevance of this research consists in reconsideration of the main approaches to solving bioethical problems based on the religious and ethical principles of Buddhism. The purpose of this research is to analyze Buddhist principles that can be consistently applied to a range of biomedical problems (euthanasia, biomedical experiments with animals, etc.). The subject of our research is ethics in the context of medicine, namely the relationship between Buddhism and medical practice. The research materials are based on many years of teaching the bioethics course at St. Petersburg State University of Chemistry and Pharmacy and Tyumen State Medical University, as well as on the results of research related to the development of scientific research of bioethical issues. The central question of modern bioethics about the nature and status of the moral subject in Buddhism is based on the principle of the moral dignity of all living beings: from human life to the life of animals and, perhaps, even plants. Belief in interspecific rebirth and respect for animal life are typical of Buddhist ethics. In modern ethics, Buddhism is a teleological ethics of virtue, which postulates a certain end result of life as the implementation of human potential and asserts that this goal should be realized through cultivation of certain spiritual practices, which implies the rejection of euthanasia, abortion, artificial insemination and other dvanced medical technologies.
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Due to the aging of the population and growing proportion of the elderly, medicine requires a more active and purposeful approach not only to study theoretical aspects of gerontology, but also to search for new drugs designed specifically for this category of the population. Clinical trials in older people are more in demand than ever. However, researchers must ensure that they conduct their studies ethically. Key ethical issues include prevention of discrimination and violations of the autonomy of older people, as well as special requirements for informing and obtaining voluntary informed consent. When preparing voluntary informed consent for older people, especially for those with cognitive decline, special attention should be paid not only to the information itself, but also to the form of its presentation. The documents should be concise, clear and contain all the key information. In addition, the use of modern multimedia technologies can help the subjects make an informed decision about their participation in the study. For patients with cognitive impairment, it is important to adhere to the principle that the higher the risk for the study participants, the more the patient’s cognitive functions and decision-making ability should be preserved. Excluding patients from studies with potential benefit due to age or cognitive impairment is considered unethical and discriminatory. This is taken as an unfair restriction of their access to the achievements of scientific and technological progress in the field of medicine.
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Medical rehabilitation is currently in an active phase of its development. This relevant area of domestic medicine is essential for human health. It helps patients recover from long-term illnesses, effects of injuries and diseases of the musculoskeletal system, peripheral nervous system and has a huge impact on the prognosis and outcome of treatment in general. This publication provides a comprehensive analysis of the ethical aspects of medical rehabilitation with an emphasis on legal definitions in medicine, which will improve understanding and regulation of relationship between rehabilitation, prevention and treatment. The research includes the study of domestic and international regulatory legal acts concerning medical rehabilitation, history of the specialty, the formulations that laid the foundation for the concept further development, consolidating an integrated approach to the issue of medical rehabilitation, as well as review of the problem-associated scientific papers. Explaining the principles of medical rehabilitation will help doctors avoid legal risks associated with their professional activity and serve as a guideline for taking ethically sound decisions in difficult clinical situations, whereas patients will get a full picture of their rights within the framework of medical rehabilitation.
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The lack of effective and affordable therapies for rare diseases is an important ethical issue. One example is cystic fibrosis (CF), a chronic, progressive disease characterized by an impaired function of all exocrine glands. The combination of ivacaftor and lumacaftor (CFTR potentiator and corrector) should lead to a sufficient level of protein on the cell surface and to an increase in its activity, thereby correcting the impaired function. Development of a generic drug containing ivacaftor and lumacaftor as active pharmaceutical substances will increase the availability of this medication and improve patient survival. To study comparative pharmacokinetics and bioequivalence of drugs containing ivacaftor and lumacaftor in healthy volunteers. It was conducted as an open-label, randomized, crossover bioequivalence study involving a single intake of the drug during each period under fed condition in healthy male and female volunteers. The conclusion about bioequivalence was made if 90% confidence interval for primary pharmacokinetic parameters (Cmax, AUC0-t) fell within the accepted bioequivalence limits of 80–125%. According to the results of the study, it was shown that the values of 90% CI of the geometric mean of the main pharmacokinetic parameters for ivacaftor and lumacaftor fall within the acceptance limits for bioequivalence. According to the applied criteria, the drugs are bioequivalent, which makes it possible to recommend the investigational drug to the Ministry of Health of the Russian Federation for obtaining the registration status.
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Clinical guidelines represent documents that contain structured information based on scientific evidence on prevention, diagnosis, treatment and rehabilitation, and regulate professional activities of the medical community. Starting from January 1, 2025, it is planned to switch to the mandatory use of clinical recommendations approved by the Ministry of Health of the Russian Federation, while the year of 2024 is an interim period for their application. However, various methodological and ethical issues arise while developing and discussing clinical recommendations. They include a conflict of interests of the authors, as well as aspects of its disclosure and settlement, accessibility of clinical recommendations for patients, as well as the discrepancy between the provisions of the recommendations and their evidence base such as results of systematic reviews and meta-analyses. Resolution of these problems will significantly improve the quality of clinical recommendations, and increase patient awareness of diseases and treatment approaches. This review analyzes a wide range of methodological problems related to the development of clinical recommendations, examines regulatory acts and ethical principles issued by government agencies, professional communities and international organizations, and makes suggestions to reduce the level of bias and, as a result, to increase the degree of evidence of clinical recommendations.
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