The new national ethical guidelines for medical and health research involving human subjects were enacted in December 2014. The new Guidelines are the first governmental guidelines in which the ethical framework of “risk-benefit assessment” that is internationally recognized as a common normative framework of research ethics has been formally introduced in the Japanese regulatory system. The new Guidelines clearly distinguish “SINSHU” (invasiveness) which causes with certainty, by the Guidelines’ definition, injuries or distress to research subjects’ body and/or mind, from “RISUKU” (risks) which is defined as an uncertain possibility of harm. However, because the new Guidelines’ actual practical scheme of “risk-benefit assessment” is based ex parte on “SINSHU”, it not only has little conformity with the international risk-benefit framework, but also generates regulatory distortions in the human subjects protection and the assurance of integrity and transparency of research. This paper discusses those ethical issues concerning regulatory distortions in the new Guidelines.

    It is often noted in bioethics that “Takasebune” is a work expressing “mercy killing.” However, there is an interpretational problem with this work regarding two subjects― “chisoku (contentment) ” and “euthanasia.” Examining Ogai Mori’s view of euthanasia is necessary to understand the problem. In this paper, I survey four matters associated with Ogai Mori: the introduction of a theory of euthanasia in Germany, the experience as a medical officer in the Japanese-Russo War, the failed attempt of euthanasia on his eldest daughter, and his own last words. I then argue that it is possible to interpret the above-mentioned matters in “Takasebune” based on the idea of “akirame (Resignation)” that was served as the basis of Ogai’s life; in other words, it is possible to view “chisoku” as “resignation of property,” and “euthanasia” as “resignation of life.” However, the word “akirameru” has two meanings: an old meaning “to clarify reason” and a new one “to give up,” and Ogai seemed to use the word to have a double meaning. The idea “euthanasia as ‘Resignation’ ” overturns the view that “mercy killing” is the only Japanese traditional alternative to the Western view of euthanasia based on the individual right to self-determination, and it offers another non-Western view.

    Human dignity and discourse are two elements that play extremely important roles in contemporary bioethics. However, the concept of “human dignity” is often criticized for being too vague. This paper focuses on human dignity from the discourse ethics perspective, which considers discourse as a key element of ethics, and attempts to redefine the concept of “human dignity.” Mathias Kettner believes that human dignity is originally a vague concept whose content must be determined through social discourse. Uwe Fahr, in contrast, interprets it as a heuristic instrument for clarifying the interests of those involved in case discussions. Based on these arguments, this paper will indicate that consensus reached through discourse is probable at a clinical level as well as at a social level and that consensus at a clinical level presupposes a certain quality of human dignity, which cannot be formulated as a principle and is known only through sensitivity.

    This paper tries to extract major matters cited as ethics subjects in syllabuses and curriculums of universities with care worker training courses and analyzes the characteristics thereof with the aim of ascertaining the current status of ethics education in such university courses in Japan. As a result, it was found that almost all targeted universities put in place ethics-related subjects, such as bioethics and ethics in providing care. However, ethics education has generally been introduced as elective subjects, which students do not necessarily take, and often as subjects for freshmen and sophomores. Furthermore, specific contents of lectures are mainly centered on fundamental knowledge, and such lectures fall short of having students learn how to deal with concrete ethical problems in a real situation. Nevertheless, universities are increasingly introducing ethical contents in curricula for their care worker training courses as part of the specialized subjects (such as overview and methodology concerning provision of care and practical training) for developing a sense of professionalism and deepening sympathy for care recipients. The combination with ethics-related subjects is expected to generate a synergistic effect, prioritizing both fundamental knowledge and advanced practical exercises.

    This purpose of this paper is to examine chronologically the statements of Ando Kakuichi, M.D., who directed the first birth by ART (artificial insemination by donor) in Japan, with due care and attention to the anonymity of sperm donors. The Japanese pioneer of AID made it a condition of its implementation that the donor should be kept anonymous. Therefore the babies born under this condition won’t be able to know their biological origin. In recent years, it has been pointed out that the children born by AID are seized with an urge to know their genetic father. However this issue had already been raised after the introduction of AID to Japan. In this paper we carefully followed Ando’s statements from 1949, when the first baby was born by AID, to 1968, when Ando died. The result clearly shows the change of Ando’s standpoints concerning the anonymity of donors and his recognition of the necessity of public arguments over this new medical technology to continue its implementation.

    Many of the participants in this study were either those who had one of their parents passed away or suffering from a disease or those whose parents were nursing each other, so the participants, who were grandchildren, were taking care of their grandparents all by themselves. The nursing-care insurance, while available, provides only limited benefits if there is a family member living together, and the distressing situation is left unattended especially for younger-generation caretakers. Meanwhile, none of the participants was receiving any livelihood subsidies for economic support but was in needy conditions, as they felt solitude and estrangement as well as uncertainty for the future. They had little association with the same generation. Therefore, it would be our pressing task to grasp the existence of these younger generation caretakers, starting from our own backyard such as schools, communities, etc. so that those who have difficulty in participating in family functions may not be isolated from society to have their future closed in or they may not have themselves isolated. Support to care for younger generation caretakers must be given urgently in such a way as to cause no new stigma as we respect and value the feelings of the younger generation

    Since the German parliament passed its Embryo Protection Act in 1990, the interpretation of the law has been that preimplantation genetic diagnosis (PGD) is prohibited in Germany. However, since 2006, a gynecologist in Berlin has been performing PGD on blastocysts derived from infertile couples who voluntarily underwent the process. The Federal Court of Justice decided in 2010 that the Embryo Protection Act could not be applied in such cases. Heated public arguments reemerged followed this judgment, and the parliament revised the act in 2011 to partially admit PGD. This paper investigates the opinion of the German Ethics Council, as provided in 2011, which summarized many discussions that had a great influence in the course of the legal revision.
     The study focuses on the emotional and existential conflicts of genetically burdened couples. The German Ethics Council discussed the controversy between the positions pro and contra PGD, but both positions commonly acknowledge the seriousness of the suffering of such couples. On the one hand, the council members who approved the ban on PGD claim that a PGD cannot decrease the troubles of these couples, because the technique itself brings about physical and mental agony Moreover, society cannot stop the escalation of the permitted extent of PGD. On the other hand, members who support restricted permission claim that legal limits of permitted PGD are practicable, and genetically burdened couples have no other way than PGD to solve their problems. This paper points out that German society is still divided on this problem, but it is under standable why the latter position is persuasive “restricted” permission to perform PGD.

    This paper aims to consider the form of argument itself in bioethics from semantic viewpoint. In the field of bioethics, it is common to presuppose those concepts such as “life,” “equity,” “freedom,” “human dignity” and to deduce consequences in the context of individual problems. However, if we reconsider the fundamental question “what are the meaning of words”, we will find a problem of relations between signs and meanings in general. Referring semiotics of C. S. Peirce and N. Goodman, this paper demonstrates that the meaning of signs do not exist out of our semiosis but we ourselves are deeply involved in making worlds of meanings. And it will be pointed out that the arguments of bioethics in which we deduce a conclusion from those fundamental concepts are unreasonable in some point. As a conclusion, this paper will propose some postulates which we should adopt to make our argument in bioethics constructive.

    Our aim of this study was to examine whether the concept of “futile care” or “medical futility”can justify either withholding or withdrawing treatment for neonates with serious congenital disorders. To achieve this aim, we used the following arguments.
    Firstly, we pointed out that there are at least five different (and sometimes inconsistent) interpretations of “medical futility”. Of these, only “physiological futility” can be used as an accurate and objective criterion for medical diagnosis. Secondly, we argued that “physiologically futile care” does exist and considered the legitimacy of the claim that the patients have no right to request medical practitioners to provide such care. Thirdly, we deliberated over the validity of withholding or withdrawing treatment for seriously impaired neonates, taking into account the relationship between “medical futility” and “normative futility”, and the ethical acceptability of including cost-effectiveness debates into medical decision-making. Finally, we highlighted the following points:
    (1) Deciding to withhold or withdraw treatment for seriously impaired neonates based on medical futility inevitably leads to their death. Thus, such decisions should not be made without also exploring questions around the “value” of life.
    (2) The concept of medical futility is not able to consider the value of life, because such a judgment is not a medical, but rather a normative one. As such, it is beyond the jurisdiction of the medical profession.
    (3) Even though neonates lack autonomy and have no capability to express their own will, they should not be denied the right to receive any treatment that their family does not consider both medically and normatively futile.
    (4) Although cost-effectiveness considerations often form part of the medical futility debate, withholding or withdrawing treatment for seriously impaired neonates for economic reasons could be considered malpractice, or even an unacceptable denial of their right to live, the most fundamental human right that must, therefore, be guaranteed.
    We conclude, then, that “medical futility” is not an ethically indisputable reason for either withholding or withdrawing treatment for seriously impaired neonates.

    The purpose of this report is to consider appropriate Advance Care Planning (ACP) processes and specific assistance by analyzing the timing of the confirmation by visiting end-of-life home care nurses of the intentions of care recipients and the specific assistance provided by said nurses. I conducted semi-structured interviews of visiting nurses with 3 or more years of experience using an interview guide. Twenty-three visiting nurses were interviewed with regard to 34 non-cancer patients aged 65 or older living with family members. The visiting nurses confirmed the intentions of care recipients in six different circumstances: upon commencing home care; while providing daily care; upon changes in the health condition of care recipients; when care recipients reach the terminal phase; where the nursing care burden on family members becomes overwhelming; and when the nursing requirements of the patient have exceeded levels that can be managed by family members. 18 distinct times at which visiting nurses confirmed the intentions of care recipients were extracted. Nurses determined confirmation timing not only by visually checking mental and physical changes but also through daily conversation while providing nursing care. Visiting nurses attempt to provide optimal, individualized end-of-life care by assisting care recipients and their family members in forming closer relationships and by helping care recipients prioritize their own intentions and wishes in making independent decisions. The timing of the confirmation of the intentions of care recipients and subsequent dialogue between care recipients, their family members, and medical teams are part of the ACP process. The research results imply that one of the most important duties of nurses assisting ACP is to provide insight based on the prioritization of daily care and assessments underpinned by sufficient medical knowledge and communication skills to build trust and allow care recipients and their family members to express their true wishes.

    We need to examine the ethical considerations for conducting clinical trials of experimental medical countermeasures against deadly infectious diseases in countries where basic healthcare systems and medical services infrastructures have deteriorated, such as those where the Ebola virus disease （EVD） outbreak emerged during 2014-2015. Due to the high mortality of EVD, these clinical trials should be designed with particular consideration for their socio-medical acceptability in local healthcare settings. This article addresses ethical challenges to determine appropriate design of clinical trials in such extremely resource-poor settings. First, we examine acceptable conditions for compassionate use of experimental medicines, by taking a brief look at actual cases to access to such medicines, particularly during the epidemics of 2014-2015. Second, we sort out arguments for and against randomized controlled trials （RCT） of experimental drugs for treating diseases like EVD that include placebo usage. Third, we examine if RCT in such circumstances can be justified as a scientific standard in view of social benefit, efficient allocation of limited supply of experimental drugs, and potential bias in efficacy and safety determinations caused by using extra-trial data. Based on the above analyses, fourth, we attempt to rationalize that RCT may be neither ethical nor practical to pursue under the circumstances where clinical equipoise underlying the ethical foundation for RCT has collapsed, especially where public distrust against modern medicine persists. On the above-noted basis, fifth, we examine the ethics of clinical trials referring to the one example conducted during EVD outbreak.

    The proposed “draft Advance directive (AD) law” holds that, given that certain physicians who withdrew life-sustaining treatments (LSTs) have been prosecuted, there is a need to provide legal protection to physicians who carry out such acts. We discuss this in the context of a major court case, the “Kawasaki Kyodo Hospital case,” in which a physician withdrew LSTs and ordered the injection of a muscle relaxant to a patient in a coma. Generally, the Kawasaki Kyodo Hospital case, which was heard by the Supreme Court, is understood by the public without a full grasp of the legal implications. Here, we analyze the legal exegeses of the court decisions surrounding this case.
    The following three issues were identified from our analysis:
1. Ambiguous relationship between “respecting patient self-determination” and “limits of treatment obligations,” which were indicated as a set of conditions within which withdrawing LSTs could be judged legal by the court: some commentators made a point that these two arguments should be used separately, while others believe they should be used together;
2. Need for family proxy or presumed consent: some say this leads to respect for patient self-determination, whereas others suggest it leads to familial determination (decision-making by the family); and
3. Whether or not withdrawing and withholding LSTs are equivalent: in Western countries, there may not be a legal or moral difference between the two; however, clinical settings in Japan are more hesitant about withdrawing LSTs than withholding it.
    Our findings suggest that a number of factors regarding physicians’ hesitancy of withdrawing LSTs should be addressed. Moreover, legalization and formulation of relevant guidelines should be considered by the government. Proxy consent by the family and support for patient’s decision-making must also be kept in mind when considering the draft law.

    The ethical issues in medical care are the decision-making issues that occur in the contradicting values in clinical situations, and the purpose of studying ethics in medical care is to learn the basic way of thinking and concepts related to these ethical issues. This study, as basic material of ethical education, elucidates the background mind-frameworks of medical students when they would have to make choices as persons concerned in the cases of career or giving birth.
    In this study, free-writing reports under the topic “Decision-making of Women with Careers at the Time of their Pregnancy” that were submitted by 96 first-grade-students of a medical college (nursing science major: 68, clinical laboratory major: 28) were analyzed. 1) Under the view of (physical) life, those who selected giving births made their choices based on “dignity of life” and those who selected their careers made the choices based on “quality of relationships.” 2) Under the view of (collective) life, those who selected giving births consider bearing and rearing children to have positive effects on their career and their own development whereas those who selected their career see such experiences as obstacles or impediments. 3) In terms of human relations, those who valued their relationship with their spouses in family and societal relations selected giving birth. Those who selected their career stress the importance on the personal and emotional aspects of bilateral relationship of “the baby-to-be-born and one’s self.”

    In February 2015, UK became the first nation in the world to legalize the so called “mitochondrial replacement” procedure. Although this procedure can be performed in Japan, there are few arguments regarding its ethical aspect. Therefore, two goals for this paper were as follows: to evaluate the ethical problems associated with mitochondrial transfer, which were criticized in previous studies, and to critically consider the unique ethical problem of “three genetic parents” associated with this technique. The ethical problems reported in the previous studies can be summarized as follows: 1） the problem with harm, 2） the problem that mitochondrial replacement can lead to other ethically questionable procedures, such as genetic modification or enhancement, 3）the problem with the identity of any baby born using this technique, and 4） the problem of “three genetic parents.” The last problem, in particular, can be a unique and interesting ethical inquiry. Furthermore, this problem is associated with two more questions, which need to be considered more carefully: 1） whether mitochondrial replacement will truly bear a baby who has “three genetic parents” and 2） are there any ethical issues with the birth of such a baby. If my arguments are valid, it is not sure whether this technique would bear a baby who had “three genetic parents” because only few genetic effects from mtDNA will be passed on to the characteristics and traits of the baby. In comparison with human reproductive cloning, with mitochondrial replacement it is difficult to say if a donor who provided mtDNA is actually a genetic parent. Furthermore, if a baby has “three genetic parents”, it was not apparent that to give a birth of such a child is ethically problematic, because, in our social context, there are some babies who have more than three parents.

    In 1996, narrative ethics emerged as an alternative to abstract, principle-based biomedical ethics. Its significance or usefulness in the field of clinical ethics has not been fully and critically investigated yet; some authors have argued that in medical ethics, there had been a tendency to romanticize the word “narrative.” This paper closely examines incoherent narratives by proponents of narrative ethics about its most important features. It is argued that the word “narrative” is not always necessarily to be used, and narrative ethics should be identified simply with the casebased approach or included within hermeneutical, “dramatological” ethics or care ethics. It is also suggested that it may remain, at most a slogan-like dogmatic imperative for medical professionals to handle with care fragile narratives of patients.

    In recent years, which have seen medicine and its systems highly developed, medical providers give patients exceedingly specialized and complex information. In this kind of circumstance, patients can no longer make self-determinations in the traditionally genuine sense, which assumes individuals are “with fully rational competence,” “with sufficient understanding” and “under no coercion from outside.” Instead, patients tend to make ethical judgments without completely understanding specialized information while “having no fully rational competence,” “lacking sufficient understanding,” and “being often concerned with and influenced by various issues in their lives”thus having no choice other than relying on some social systems, i.e., external “apparatuses” in making the judgments. I characterize this tendency with the notion of “packaging of ethical judgments.” What moral responsibility should we attribute to those who make judgments in this fashion? To answer the question, I propose to distinguish legal responsibility from moral responsibility, and contend that we maintain the efficacy of social systems by applying the former, while contributing to moral inclusion movements in society by construing the latter in a wider, non-strict sense.

    This paper considers two instances of experimentation performed on infants in Japanese infant homes in the 1950s. In these experiments, healthy infants were provided with harmful Escherichia coli through oral ingestion by Nagoya City University professors and with highly concentrated lactose through tubing by Hyogo Prefectural Medical College professors. This research examines the background of infant homes, which were established as part of Japan’s postwar child welfare policy, the career of the pediatricians involved in these experiments, the influence of related industries on their research, and the processes and context within which their experiments were problematized. Following the end of the tradition of midwives sheltering infants in private maternity homes, many infants who had been orphaned, or were living in deprived conditions due to their parents’poverty, were sheltered in postwar public infant homes established inside university hospitals. Some of these infants became the subject of human experiments. Research on the dangers of certain kinds of Escherichia coli was carried out by doctors related to Unit 731 of the Imperial Japanese Army, which undertook biological and chemical warfare research on human beings during World War II. Experiments on the risks of lactose density in milk for infants was motivated by its assumed impact on the powdered milk industry, which was growing rapidly in 1950s Japan. A pediatrician and a nurse brought accusations against those performing the experiments at each of the two hospitals, and the Japan Federation of Bar Associations and a local Legal Affairs Bureau investigated the cases to prove human rights violations. The possible criminal culpability of the doctors was also suggested by one jurist in the 1950s.

    While patient-centered and will-respected end-of-life medical treatment and care is needed, there are still many difficulties in the support process for patientsʼ decision making about their own end of life. In this paper, we would like to highlight the necessity for a “learning community”in order to know, consider and discuss the problems on disease and death. As a trial, we have implemented a citizen participatory program on end-of-life care and have examined the meaning of such a “learning community” for end-of-life care. As a result, it is indicated that such a practice has important effects on the participants, such as giving them the feeling of cultivating an active and responsible way of life and of being supported by others. At the same time, as many of the participants have had difficulties speaking to their family about end-of-life, we could observe that a place to think and talk about such matters with people outside the family is highly needed. Such a place should be conceived as one where the participants themselves can examine and explore the way they want to conduct their own life.

    By introducing “Morality as a Special Subject,” the chances to guide elementary and junior high school students to develop a deeper respect for life have increased. Furthermore, prejudice against Hansen’s disease patients and former patients, and the elimination of discrimination against them can be used as a teaching example to help students explore the concept of human rights. In this article, a report on university students enrolled in a teacher-training course who are considering different methods of teaching about respect for human rights will be given. In particular, evidence of students overcoming Hansen’s disease discrimination while doing fieldwork at the National Hansen’s Disease Sanatorium will be presented. This evidence comes from analyzing students’ reports and from interviews. Former teacher-training course students, who are now working as teachers, were also interviewed.
    The results bring to light ways in which such field experiences might be used later by teachers in their classrooms. The significance of chances for prospective teachers to think about bioethics in a university teacher-training course is reconfirmed. This type of learning activity also shows promise for helping to provide students with an education that does not stop with knowing the “correct information.” Instead, by being introduced to some different perspectives of bioethics, students can obtain a deeper insight into human dignity.

    At present, research that tries to create reproductive cells from human iPS cells is being carried out. One of its aims is to use reproductive cells created from somatic cells for fertility treatment within the range of reproductive medicine. Unlike when reproductive cells are donated by others, a patient would be able to have his or her own biological child by using reproductive cells created from his or her own somatic cells. It is also possible to create embryos, either by fertilizing two reproductive cells created from somatic cells or by reprogramming somatic cells. In this case, the ethical problems surrounding cloning will be revived. Moreover, it is also possible to treat patients suffering from hereditary diseases by combining reprogramming technology and gene manipulation, in which case the ethical problems surrounding gene therapy will be revived. Since the historical development of somatic cell reprogramming technology, the boundary between somatic and reproductive cells has been increasingly blurred. As such, we will from now on have to treat somatic cells with the respect and care due a potential human being, in much the same way as we currently do with embryos.