This paper aims to review the progression and current state of clinical ethics committees (hospital ethics committees) and consultations in Japan, to define the roles these institutions play in medical settings, and to examine challenges they face along with potential solutions. In the 1980s, medical schools began establishing ethics committees (institutional review boards) that has been designated to review and monitor biomedical research involving human subjects. By the 90s, these committees reviewed not only research protocols, but also ethical dilemmas faced in clinical settings. Eventually more specialized clinical ethics committees emerged which focused on providing clinical ethics consulting. Currently about a quarter of Japanese hospitals report voluntarily running clinical ethics committees and consultations, despite the fact no laws or official guidelines regulating them exist. Judgement guided by clinical ethical consulting should be considered to have legality. The main functions of clinical ethics committees and consultations are 1) providing ethical advice on specific cases, 2) developing guidelines for the hospital, and 3) providing information and training to medical personnel. Challenges include 1) record keeping, 2) information sharing, 3) promotion, and 4) sustainability. Potential solutions to aforementioned challenges are 1) creating minutes of meeting for committee, 2) share knowledge through academic conferences and professional organizations, 3) reaching out medical professionals in the community where ethical consulting is in demand, and 4) appointing dedicated staff in order to sustain the activities.

    Public funding for the treatment of costly rare diseases is often a matter of debate in bioethics and political philosophy. This paper discusses how the dominant distributive justice theories treat rare diseases. We examine the quality-adjusted life years (QALY) model and luck egalitarianism, because these are currently the most influential theories involving justice in the realm of healthcare. As a theory focusing on cost-effectiveness, the QALY model values the cost of achieving a certain level of health improvement through medical intervention. However, since the treatment costs of rare diseases are commonly very high, this type of evaluation is disadvantageous to patients with rare diseases. In addition, since the costs of medical treatments usually depend on the research activities of pharmaceutical companies, which are profit-seeking entities, the treatment costs of diseases with few patients are unlikely to go down. On the other hand, luck egalitarianism is a normative theory claiming that official funds should be provided for the treatment of the victims of brute luck, not of option luck. At first glance, the theory seems to be advantageous to rare disease patients. However, the hypothetical insurance market envisioned by Dworkin, the originator of luck egalitarianism, was designed to leave rare diseases out of its reach. In the final section of the paper, we point out the problematic premise shared by both the QALY model and luck egalitarianism―that of ableism. The measurement of quality of life is essential for QALY evaluation; however, the quality of life of disabled people is often unfairly underestimated. Moreover, the proponents of luck egalitarianism uncritically view disabilities as mere bad luck and misfortune, something to be prevented as much as possible. We need to break away from the ableist perspective of philosophical theories, pay attention to the needs of rare disease patients, and change the way medical research is conducted, which at present is largely led by pharmaceutical companies.

    The COVID-19 pandemic has triggered a debate on whether triage constitutes discrimination. From the standpoint of consequentialism, the theory of triage, which determines the priority of lifesaving measures, leads to the conclusion that patients with a high chance of survival should be prioritized, without simultaneously discriminating against the elderly or patients with underlying diseases. Based on the rule of maximizing the number of lives saved, it is easy to form a consensus that is useful in guiding medical practice. However, existing theories disregard the role of politics and do not consider the variability of medical resources under the pandemic, thereby resulting in a kind of fallacy of composition concealing the discrimination caused by inadequate infection control. Triage in the pandemic is political and requires a different theoretical framework than the one for disasters or accidents. In this paper, we attempt to develop a expanded theoretical model that deals with triage for the entire region, while considering the medical system from the perspective of the mildly ill to the severely ill as well as the time required for its preparation. The purpose of this paper is to explore the landing point of the controversy over discrimination by conducting a thought experiment within the framework of consequentialism. In short, when the principle of maximizing the number of lives saved is thoroughly applied at the regional level, the expansion of medical resources based on the maximin rule, which prioritizes the vulnerable, becomes the most important ethical requirement. Ensuring the preservation of life under a pandemic is consistent with the vision of justice emphasizing equality.

    Even though interventions for pregnant women affect the fetus in the womb in various manners, many of these effects are not well understood. This makes medical research on fetuses necessary. However, in Japan and other countries, the discussion on how to involve fetuses in research is insufficient. Therefore, in this paper, we will 1) confirm the status of involving fetuses in research as per the current ethical guidelines for research in Japan and other countries; 2) categorize the types of research which may involve fetuses; and 3) identify studies where the fetus should have been considered the subject. We confirmed that at least some of the studies should have considered the fetus as the subject. We further discussed 4) the practical implications of considering the fetus as the research subject and determined that the concept of “fetus as the research subject” can be introduced where intervention for pregnant women is performed for the health of the fetus itself and where intervention is performed for the fetus itself. However, we have shown that there are various problems to be considered in such cases.

    In times of great disasters, such as heavy earthquakes, floods, and pandemics, prompt implementation of medical and healthcare research is often very important in order to recognize the health conditions of disaster-affected people, make plans for treatment and healthcare support, and determine necessary public health policies. As a general international rule of research ethics, research protocols need to be reviewed and approved by an ethics review board prior to medical and healthcare research implementation. However, because this standard procedure delays initiation of a research study immediately after a disaster, several alternative systematic approaches have recently been proposed. Based on these, and by referring to research protocols submitted for an ethics review in the early phase of a disaster at two major research institutions in Tohoku and Kumamoto, both of which had experienced several disasters of similar magnitude in the past decade, we discuss and propose an ethical and feasible systematic approach for a timely ethics review of medical and healthcare research for disaster preparedness.

    There is a momentum for clinical ethics committees or hospital ethics committees (HECs) and research ethics committees (RECs) in medical institutions in Japan to become independent. We conducted a survey of the actual status of HECs by a questionnaire survey and an analysis of committee rules from July to September 2020. The survey covered 447 hospitals, including hospitals with cancer treatment centers. The questionnaire collection rate was 35.8％ and the rule collection rate was 24.4％. The most important findings of the survey were as follows. While 96 (67.1％) of the respondents to the questionnaire survey said their committees were “established as specialized committees to deal with clinical ethics issues”, an analysis of the 109 regulations collected showed that 46 (42.2％) committees were recognized as HECs under the regulations. This means there is a gap between the percentage of respondents who recognize their own committees as HECs and the percentage of HECs that the author can classify as HECs judging from the regulations. Therefore, the results of the questionnaire survey, including all the responses and the responses of the committees recognized as HECs under the regulations, are written side by side to focus on the actual situation of HECs. In addition, the contents and items in the regulations confirming the 46 committees as HECs were reviewed. Finally, the paper discusses the necessity of HEC-focused surveys and the actual status of HECs in Japan.

    Hanks （2010） developed the protective nursing advocacy scale (PNAS), an instrument for assessing how nurses advocate on behalf of the rights and dignity of patients. We sought to enhance the Japanese version of the PNAS by examining its internal consistency and construct validity. A questionnaire survey was conducted on operating room nurses nationwide, 443 people were analyzed. As a result of factor analysis by Principal axis method promax rotation, 28 items of 4 factors were adopted. As a result of confirming the reliability, the Cronbachʼs α coefficient of the entire scale was 0.85, and the subscale was 0.73 to 0.90. Confirmatory factor analysis showed reasonable suitability. The reliability and validity of this scale have been confirmed to be statistically acceptable and can be used as an indicator of the degree to which nurses perform their role in advocating for the rights and dignity of patients.

    “Feminist bioethics” is a movement that connects the field of bioethics to feminism. This paper primarily aims to review previous studies, regarding a topic in feminist bioethics: feminist relational autonomy, which I define as the concept in which autonomy is argued as a base against oppression. In this paper, I first provide an overview of criticisms against being “relational” and “feminist,” in feminist relational autonomy, and admit that the argument of relational autonomy, which is not truly feminist in a sense, has certain advantages in a philosophical debate. Next, I return to movements of sexual and reproductive rights in feminism as an origin of feminist bioethics and feminist relational autonomy. Thus, I propose that advocating feminist relational autonomy as a base against oppression has historical significance and is still required as it is an integral part of feminism.

    The carrier of the genetic mutation of autosomal recessive disease is not affected by the disease. However, if two individuals who are gene carriers and have the same genetic mutation become a couple and have a child, the child has a one-in-four chance of developing severe symptoms of the disease. Consequently, since the 1970s in the United States as well as other countries, carrier screening has been conducted for specific ethnic and regional groups in an endeavor to know the risk of the disease beforehand. Recently, genetic analysis technology has become more advanced and the scope of carrier screening has been expanded to include the general population. The purpose of this paper is three-fold. First, the history and international trends of carrier screening are reviewed. Second, the guidelines for carrier screening employed in Japan and the United States are compared. Third, a summary of the ELSIs of gene carrier screening that have been discussed in previous studies are provided. Since carrier screening for the general population can also be introduced in Japan, not only for commercial purposes but also for medical reasons, it would be important to have open discussions on the ELSIs for gene carrier screening in Japan as well.

    The terminology ffor the “disorder of consciousness,” formerly classified broadly as “vegetative state,” has recently changed to unresponsive wakefulness syndrome (UWS) as a result of changes in its clinical implications. Daily care is essential for patients with UWS, and continual caregiving ensures the possibility of recovery (or discovery) even among patients who are only mildly affected by the syndrome. However, there exists no specific treatment corresponding to a precise diagnosis of the syndrome; proper care is often not provided to patients owing to a misdiagnosis. This paper argues that a conceptualization of UWS as a “stochastic turn” is crucial to ensure that clinical practices are followed and adequate care is provided to patients. To this end, we propose a probabilistic theory regarding the broad (assumed) criteria that should determine the diagnosis of the “unconscious state” and how these criteria should be established. We also show the ideal precondition for and presumption of the attitude of care, where patients are only in a communication disorder and may be conscious. Finally, we specify profitable and stochastic decision-making strategies in clinical practice and effective ways to communicate with patientsʼ families.

    After World War II, several ethical principles and guidelines for protecting human subjects of research, such as the Nuremberg Code, Belmont Report, and Code of Federal Regulation Title 45 Part 46 (45CFR46), were established. Although these principles and guidelines note that vulnerable groups such as children need special protection, this has resulted in the exclusion of these groups from participating in clinical research. In parallel, pharmaceutical industries have been wary of investing in the development of pediatric drugs, given the limited size of the market relative to that of drugs targeting adults. Thus, data on the safety and efficacy of pediatric drugs remain insufficient, and the bulk of these drugs is used off-label. This has collectively led to the unstable footing of pediatric medicine in medical and healthcare systems. In order to improve the current state of pediatric medicine, more opportunities should be provided for children to participate in clinical research. To this end, D. Wendler has attempted to justify clinical research involving children by redefining “minimal risk” and benefits. In this paper, we explore the ethical validity and applicability of his arguments.