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Abstract Despite clinical evidence of drug superiority, therapeutic modalities, like combination immunotherapy, are mostly considered cost-ineffective due to their high costs per life year(s) gained. This paper, taking an ethical stand, reevaluates the standard cost-effectiveness analysis with that of the more recent justice-enhanced methods and concludes by pointing out the shortcomings of the current methodologies.

Abstract Background In 1926, Fritz Jahr described bio-ethics (German: bio-ethik) as “the assumption of moral obligations not only towards humans, but towards all forms of life.” Jahr summarized his philosophy by declaring, “Respect every living being on principle as an end in itself and treat it, if possible, as such!.” Bioethics was thus originally an ethical system concerned with the “problems of interference with other living beings… and generally everything related to the balance of the ecosystem” according to the 1978 Encyclopedia of Bioethics. This definition was predicated on the work of Fritz Jahr, Menico Torchio, and Van Rensselaer Potter. Methods In order to proceed with depthful analysis of the origin and major bioethical flare up, we will use critical analysis of existing literature, followed by a study trip to relevant bioethical localities (collecting photo and other documentations regarding Menico Torchio). Results While Jahr and Potter are typically given intellectual credit for developing the field of bioethics, the eco-ethical contributions of Menico Torchio have been forgotten.This article will first trace the origins of “bioethics” – now commonly bifurcated into “biomedical ethics” and “environmental bioethics.” The former was developed by Tom Beauchamp from the Philosophy Department and James Childress of the Religious Studies department at Georgetown University and is based on principlism, with a narrow focus on medical settings. The latter addresses the environmental impact of the medical industry and climate change health hazards. Second, we will present a panorama of Torchio’s significant intellectual contribution to bioethics. Menico Torchio’s concept of bioethics synthesized work of both Jahr and Potter, advocating “the need to expand our ethical obligations and embrace the most developed groups of animals, not only physically but also psychologically.” Third, we will reflect on the lasting legacy of “bioethics” on biomedical and environmental bioethics today. Thematic elements such as interconnectedness of planetary health and human health, dedication to living in harmony with nature, and emphasis on systems and symbiosis remain unchanged from the legacy of Tochio onward. Conclusion Our conclusion will underscore the necessity of understanding the connections between planetary, environmental, and human health.

Objective: Most deaths in Pediatric Intensive Care Units involve forgoing life-sustaining treatment. Such deaths required carefully planned end-of-life care built on compassion and focused on palliative care measures. This study aims to assess topics related to the end of life care in Brazilian pediatric intensive care units from the perspective of a multidisciplinary team. Method: The authors used a tested questionnaire, utilizing Likert-style and open-ended questions. After ethics committee approval, it was sent by email from September to November/2019 to three Pediatric Intensive Care Units in the South and Southeast of Brazil. One unit was exclusively dedicated to oncology patients; the others were mixed units. Results: From 144 surveys collected (23% response rate) 136 were analyzed, with 35% physicians, 30% nurses, 21% nurse technicians, and 14% physiotherapists responding. Overall, only 12% reported enough end-of-life care training and 40% reported never having had any, albeit this was not associated with the physician's confidence in forgoing life-sustaining treatment. Furthermore, 60% of physicians and 46% of other professionals were more comfortable with non-escalation than withdrawing therapies, even if this could prolong suffering. All physicians were uncomfortable with palliative extubation; 15% of all professionals have witnessed it. The oncologic team uniquely felt that “resistance from the teams of specialists” was the main barrier to end-of-life care implementation. Conclusion: Most professionals felt unprepared to forego life-sustaining treatment. Even for terminally ill patients, withholding is preferred over the withdrawal of treatment. Socio-cultural barriers and the lack of adequate training may be contributing to insecurity in the care of terminally ill patients, diverging from practices in other countries.

With over 16 years of experience in clinical, research, and educational activities related to transcranial magnetic stimulation (TMS), I have written this article exploring the ethical dimensions of TMS. This article aims to provide valuable and informative content for those unfamiliar with TMS as well as those just starting in the field. Specifically, this article elaborates on four principles of medical ethics, including those applicable to TMS therapy, the disparity between public medical insurance coverage and medical indications in private practice for TMS therapy, and issues concerning research ethics in practice. I also provide recommendations regarding roles and strategies for adoption by academia and those in this field dedicated to making TMS therapy accessible to a larger patient population in a suitable manner. Lastly, it is my hope that this article will serve as a contemporary “Ethics of TMS Neuromodulation”, resonating with the inherent human pursuit of “truth, goodness, and beauty” for a sound mind and spirit.

Abstract Background The worldwide increase in older persons demands technological solutions to combat the shortage of caregiving and to enable aging in place. Smart home health technologies (SHHTs) are promoted and implemented as a possible solution from an economic and practical perspective. However, ethical considerations are equally important and need to be investigated. Methods We conducted a systematic review according to the PRISMA guidelines to investigate if and how ethical questions are discussed in the field of SHHTs in caregiving for older persons. Results 156 peer-reviewed articles published in English, German and French were retrieved and analyzed across 10 electronic databases. Using narrative analysis, 7 ethical categories were mapped: privacy, autonomy, responsibility, human vs. artificial interactions, trust, ageism and stigma, and other concerns. Conclusion The findings of our systematic review show the (lack of) ethical consideration when it comes to the development and implementation of SHHTs for older persons. Our analysis is useful to promote careful ethical consideration when carrying out technology development, research and deployment to care for older persons. Registration We registered our systematic review in the PROSPERO network under CRD42021248543.

Abstract Background We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases. Result The authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries. Conclusion This work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/CAs. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort.

June 11-12, 2020 at the O. Bogomolets National Medical University online hosted the II International Scientific and Practical Conference "Philosophy of Religion and Medicine in the Post-Secular Age" (In memory of St. Luke (V. F. Voino-Yasenetskyi). The basic department in the organization of the event was the Department of Philosophy, Bioethics and History of Medicine. The directions of the conference participants' work remained traditional and focused on: Questions of religion and medicine in life and work of St. Luke (V. F. Voino-Yasenetskyi); Methodological and historical aspects of the relationships between religion and medicine in contemporary society; Human health in the context of philosophy, religion and medicine; Religion and clinical medicine; Actual problems of biomedical ethics in contemporary religious discourse; Religion as a social and spiritual determinant of individual and public health; Philosophy of religion and medicine: current challengesю. Along with NMU named after OO Bogomolets co-organizers of the conference were: Department of Religious Studies of the G. S. Skovoroda Institute of Philosophy of the National Academy of Sciences of Ukraine; Personality Development Center "HUMANUS", Plovdiv (Bulgaria); Institute of Social Medicine and Medical Ethics at Faculty of Medicine, Comenius University in Bratislava (Slovakia).

Protection of patients' rights is critical in improving healthcare quality, and hence this study aimed at reviewing patient rights’ practices in healthcare organizations of Iran. Using systematic search, this review was conducted based on Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Several keywords, including "patient rights", "patient bills of rights" and "patients rights’ charter" were searched bilingually in the databases of SID, Magiran, PubMed, Scopus, and Web of Science from 2010 to 2021, and then, following a three-tier screening using the Critical Appraisal Skills Program (CASP) checklists, 76 articles were extracted. The degree of compliance with the Patients' Rights Charter (PRC) in healthcare organizations was 60.88% on average. As to the observance of the PRC dimensions, respectively, the highest and lowest scores were related to the "right to privacy and confidentiality" (70.16%) and "right to access an efficient complaining system" (53.01 %). Respect for patients' rights in organizations was assessed at a moderate level, and some aspects of patients' rights should be attended to immediately. Therefore, discrepancies in the dimensions of patients' rights and their implementation by organizations should be on the agenda of healthcare managers and policymakers.

The precision health era is likely to reduce and respond to antimicrobial resistance (AMR). Our stewardship and precision efforts share terminology, seeking to deliver the “right drug, at the right dose, at the right time.” Already, rapid diagnostic testing, phylogenetic surveillance, and real-time outbreak response provide just a few examples of molecular advances we dub “precision stewardship.” However, the AMR causal factors range from the molecular to that of global health policy. Mirroring the cross-sectoral nature of AMR science, the research addressing the ethical, legal and social implications (ELSI) of AMR ranges across academic scholarship. As the rise of AMR is accompanied by an escalating sense of its moral and social significance, what is needed is a parallel field of study. In this paper, we offer a gap analysis of this terrain, or an agenda for “the ELSI of precision stewardship.” In the first section, we discuss the accomplishments of a multi-decade U.S. national investment in ELSI research attending to the advances in human genetics. In the next section, we provide an overview of distinct ELSI topics pertinent to AMR. The distinctiveness of an ELSI agenda for precision stewardship suggests new opportunities for collaboration to build the stewardship teams of the future.

Bioethics as a discipline emerged at the turn of the 1960s and 1970s; from the start, the ethical component of Russian medicine played an important role in the development of bioethics. The outstanding surgeons and physicians S.G. Zybelin, P.D. Veniaminov, M.Ya. Mudrov, E.O. Mukhin, F.P. Gaas, N. I. Pirogov, V.S. Soloviev, A. E. Kozhevnikov, S.S. Korsakov, V.V. Veresaev, V.M. Bekhterev, V. F. Voino-Yasenetsky, N.N. Petrov, E.K. Sepp, A.M. Wayne, V.A. Karlov, N.N. Yakhno and many others contributed to the formation of bioethics in Russia. The Russian Antiepileptic League pays high attention to issues related to bioethics; among them, the use of original and reproduced drugs (generics), the updated classification of epilepsy, the adoption of resolutions important for the national health, as well as the medical and social program «Attention – epilepsy!» for patients and their families. The main objective of the Program is to improve the health and quality of life in patients suffering from epilepsy, and to facilitate their adaptation to the society.

Artificial intelligence (AI) is define by MeSH (Medical Subject Headings) as “theory and development of computer systems which perform tasks that normally require human intelligence. Such tasks may include speech recognition, learning; visual perception; mathematical computing; reasoning, problem solving, decision-making, and translation of language”. The keyword has been introduced in 1986 but received lately special attention due to the access to a considerable amount of organized/structured data. The AI technology in health care has raw medical data as input on which apply machine learning algorithms and provide as a specific output. The main feature of the AI is represented by the creation of its own logic by recognizing patterns in the input data but are “black boxes” that predict well without explaining why and are case-specific, the received goal is not self-adjusted. The healthrelated AI applications are developed to assist the diagnosis, development of the treatment protocol, drug development, personalized medicine, and healthcare monitoring. High-Level Expert Group on Artificial Intelligence (AI HLEG, https://ec.europa.eu/digital-singlemarket/en/high-level-expert-group-artificial-intelligence) published the Ethics Guidelines for Trustworthy AI that listed “seven key requirements for Trustworthy AI: (1) human agency and oversight, (2) technical robustness and safety, (3) privacy and data governance, (4) transparency, (5) diversity, non-discrimination and fairness, (6) environmental and societal well-being and (7) accountability.” The use of AI technology in health care and medical education arise several ethical issues regarding patient autonomy, privacy, and confidentiality, informed consent, discrimination, quantification of AI risks and benefits, responsibility, misuses, responsible conduct of AI research and testing, etc. Several AI ethical issues in health-care are introduced and discussed.

In this essay, and in his honor, I focus on two of physician-philosopher H. Tristram Engelhardt, Jr.’s many contributions, namely, his view that biomedical ethics (1) cannot offer a singular content-driven theoretical approach and (2) requires an appreciation of epistemologies of knowing in medicine. While these two positions remain controversial, because we all want definitive answers to our questions concerning what we ought to do in medicine and elsewhere, Dr. Engelhardt’s view makes possible discussion and debate in medicine to include diverse, defensible ways of knowing. In the end, Dr. Engelhardt’s approach in biomedical ethics is one of shared decision making and negotiation. This is an important model if we take respect for patients seriously in the clinical setting.

Our contribution discusses the possibilities and limits of using video games for apprehending and reflecting on the moral actions of their players. We briefly present the results of an extended study that introduces the conceptual idea of a Serious Moral Game (SMG). Then, we outline its possible application in the domain of bioethics for training medical professionals such that they can deal better with moral problems in medical practice. We briefly sketch major components of a SMG Bioethics. The contribution should demonstrate how such an instrument may improve psychological competences that are needed for dealing with various ethical questions within healthcare. The contribution is an intermediate step of a project that aims at actually creating a SMG for training in moral competences that are needed for putting bioethics in practice.

The paper presents an overview of current, mainly foreign, researches on ethical problems of gerontology. The meaning of the concept of biomedical ethics as a moral relation of professional society - doctors, psychologists, biologists - to the man, his life, health and death is revealed. The principles of the Program in Bioethics (2001) are treated, it is argued that in the domestic science and medical practice the provisions of bioethics dementia in old age are developed insufficiently. The problems of diagnosis and report to the members of the family of the patient with dementia, problems of stigma and ethical problems of therapy, of the preclinical stage of dementia and end-stage disease are discussed.

The lifesaving processes of organ donation and transplantation in neonatology and pediatrics carry important ethical considerations. The medical community must balance the principles of autonomy, nonmaleficence, beneficence, and justice to ensure the best interest of the potential donor and to provide equitable benefit to society. Accordingly, the US Organ Procurement and Transplantation Network (OPTN) has established procedures for the ethical allocation of organs depending on several donor-specific and recipient-specific factors. To maximize the availability of transplantable organs and opportunities for dying patients and families to donate, the US government has mandated that hospitals refer potential donors in a timely manner. Expedient investigation and diagnosis of brain death where applicable are also crucial, especially in neonates. Empowering trained individuals from organ procurement organizations to discuss organ donation with families has also increased rates of consent. Other efforts to increase organ supply include recovery from donors who die by circulatory criteria (DCDD) in addition to donation after brain death (DBD), and from neonates born with immediately lethal conditions such as anencephaly. Ethical considerations in DCDD compared to DBD include a potential conflict of interest between the dying patient and others who may benefit from the organs, and the precision of the declaration of death of the donor. Most clinicians and ethicists believe in the appropriateness of the Dead Donor Rule, which states that vital organs should only be recovered from people who have died. The medical community can maximize the interests of organ donors and recipients by observing the Dead Donor Rule and acknowledging the ethical considerations in organ donation.

Medical activity, which always includes the necessity to solve a system of logical, gnoseological, axiological, and praxiological problems as sociated with the process of diagnostics and treatment of a patient, can be successful only with high culture of a specialist. It is a moral obligation of a medical practician to become a man of culture. Based on a systematic approach, the paper presents medical culture as a specific subsystem of general culture, whose mastering starts in childhood, develops in university, and continues for the whole life, demanding colossal mental ener gies. Part 2 reveals the content of world outlook and philosophic-anthropological aspects of medical culture, grounds the necessity of the revise of the existing anthropological paradigm.

The argument of human dignity plays an important role in current debates on human rights and their relevance in modern biomedicine. When discussing the contribution of Christian theology to current debates on human dignity and human rights the thesis is not that the modern idea of human dignity depends on a theological grounding. Also, it is not the task of theology to legitimate rights as Christian a posteriori. We do not need to deduce modern human rights from theological doctrines. The theological challenge is to find an access for Christians from their belief to the modern idea of human rights and human dignity and to discuss the contribution which theology and the churches can make to further development of human rights. The Christian image of man, which serves as the foundation for the church position on bioethical topics in the German-speaking context, is a mix of biblical motives, a Kantian interpretation of the concept of human dignity and an interpretation of the German constitutional law inspired by the Catholic tradition of natural law. The following presented theological understanding of human dignity, in contrast, was inspired by the insights of the Pauline doctrine of justification and its Protestant reinterpretation.