We examined the ethical justification for a national policy governing public funding for the induced pluripotent stem cell stock project in Japan and argue that the initiation of the iPSC stock project in 2012, when no clinical trial using iPSC-derived products had yet succeeded, was premature and unethical. Our analysis considers a generally accepted justice criterion and shows it fails to justify public funding of the iPSC stock project. We also raise concerns related to the massive amounts of public funding (...) at stake and the absence of evidence supporting claimed success rates. We conclude that the iPSC stock project should be re-considered and deferred until a substantial number of clinical trials using iPSC-derived products are deemed successful. This analysis should benefit others worldwide as they consider their own public funding policies. (shrink)
Informed consent, decision-making styles and the role of patient-physician relationships are imperative aspects of clinical medicine worldwide. We present the case of a 74-year-old woman afflicted with advanced liver cancer whose attending physician, per request of the family, did not inform her of her true diagnosis. In our analysis, we explore the differences in informed-consent styles between patients who hold an "independent" and "interdependent" construal of the self and then highlight the possible implications maintained by this position in the context (...) of international clinical ethics. Finally, we discuss the need to reassess informed-consent styles suitable to the needs of each patient regardless of whether he or she resides in the United States or in Japan. (shrink)
Today Asia is attracting attention in the area of bioethics. In fact, the potential of bioethics is beginning to be discussed seriously at academic centers across Asia. In Japan, this discussion began a decade ago with the publication The book is one of the principal explorations of biomedical ethics involving Japan to date. Tom Beauchamp, an author of one of the book's chapters, compares Japanese and American standards of informed consent and refutes relativistic positions, concluding that.
BackgroundMost medical schools in Japan have incorporated mandatory courses on medical ethics. To this date, however, there is no established means of evaluating medical ethics education in Japan. This study looks 1) To develop a brief, objective method of evaluation for moral sensitivity and reasoning; 2) To conduct a test battery for the PIT and the DIT on medical students who are either currently in school or who have recently graduated (residents); 3) To investigate changes in moral sensitivity and reasoning (...) between school years among medical students and residents.MethodsQuestionnaire survey: Two questionnaires were employed, the Problem Identification Test (PIT) for evaluation of moral sensitivity and a portion of the Defining Issues Test (DIT) for moral reasoning. Subjects consisted of 559 medical school students and 272 residents who recently graduated from the same medical school located in an urban area of Japan.ResultsPIT results showed an increase in moral sensitivity in 4th and 5th year students followed by a decrease in 6th year students and in residents. No change in moral development stage was observed. However, DIT results described a gradual rising shift in moral decision-making concerning euthanasia between school years. No valid correlation was observed between PIT and DIT questionnaires.ConclusionThis study's questionnaire survey, which incorporates both PIT and DIT, could be used as a brief and objective means of evaluating medical students' moral sensitivity and reasoning in Japan. (shrink)
While the world rushed to develop treatments for COVID-19, some turned hopefully to drug repurposing. However, little study has addressed issues of drug repurposing in emergency situations from a broader perspective, taking into account the social and ethical ramifications. When drug repurposing is employed in emergency situations, the fairness of resource distribution becomes an issue that requires careful ethical consideration.This paper examines the drug repurposing in emergency situations focusing on the fairness using Japanese cases. Ethical issues under these circumstances addressed (...) by the authors include: maintaining the evidence level, integrity of clinical research ethics, and voluntary consent by original indication patients. In order to address these issues, they argue that rapid accumulation of ethically and scientifically valid evidence is required, as is obtaining information on resource quantity. (shrink)
BackgroundIn Japan, discussion concerning advance directives has been on the rise during the past decade. ADs are one method proposed to facilitate the process of communication among patients, families and health care providers regarding the plan of care of a patient who is no longer capable of communicating. In this paper, we report the results of the first in-depth survey on the general population concerning the preferences and use of ADs in Japan.MethodA self-administered questionnaire was sent via mail to a (...) stratified random sampling of 560 residents listed in the residential registry of one district of Tokyo, Japan . Association between correlating factors and specific preferences toward ADs was assessed using contingency table bivariate analysis and multivariate regression model to estimate independent contribution.ResultsOf the 560 questionnaires sent out, a total of 425 participants took part in the survey yielding a response rate of 75.9 %. The results of the present study indicate that: 1) the most important components to be addressed are the specifics of medical treatment at the end of life stage and disclosure of diagnosis and prognosis; 2) the majority of participants found it suitable to express their directives by word to family and/or physician and not by written documentation; 3) there is no strong need for legal measures in setting up an AD; 4) it is permissible for family and physician to loosely interpret one's directives; 5) the most suitable proxy is considered to be a family member, relative, or spouse. Multivariate analysis found the following five factors as significantly associated with preferences: 1) awareness regarding living wills, 2) experience with the use of ADs, 3) preferences for end-of-life treatment, 4) preferences for information disclosure, and 5) intentions of creating a will.ConclusionsWritten ADs might be useful in the Japanese setting when the individual either wishes: 1) to not provide a lot of leeway to surrogates and/or caregivers, and/or 2) to ensure his or her directives in the cases of terminal illness, brain death, and pain treatment, as well as regarding information disclosure. (shrink)
BackgroundFew comparative studies of clinical ethics consultation practices have been reported. The objective of this study was to explore how American and Japanese experts analyze an Alzheimer's case regarding ethics consultation.MethodsWe presented the case to physicians and ethicists from the US and Japan (one expert from each field from both countries; total = 4) and obtained their responses through a questionnaire and in-depth interviews.ResultsEstablishing a consensus was a common goal among American and Japanese participants. In attempting to achieve consensus, the (...) most significant similarity between Japanese and American ethics consultants was that they both appeared to adopt an "ethics facilitation" approach. Differences were found in recommendation and assessment between the American and Japanese participants. In selecting a surrogate, the American participants chose to contact the grandson before designating the daughter-in-law as the surrogate decision-maker. Conversely the Japanese experts assumed that the daughter-in-law was the surrogate.ConclusionOur findings suggest that consensus building through an "ethics facilitation" approach may be a commonality to the practice of ethics consultation in the US and Japan, while differences emerged in terms of recommendations, surrogate assessment, and assessing treatments. Further research is needed to appreciate differences not only among different nations including, but not limited to, countries in Europe, Asia and the Americas, but also within each country. (shrink)
In Japan, modern biomedical ethics emerged in the early 1980s. One of the main triggers was the nationwide debate on organ transplantation and brain death. A lengthy process of academic, religious, and political discussion concerning organ transplantation, lasting well over a few decades, resulted in the enactment of the Organ Transplantation Law in 1997.1 The defining of death and other bioethical issues, including death with dignity and euthanasia, were also stimulating topics throughout the latter end of the twentieth century. For (...) instance, the death-with-dignity movement, which started around the late 1960s, developed into a hospice/palliative-care movement by the end of the 1980s. (shrink)
In the past few years, a second phase of biomedical ethics in Japan has begun to surface with a succession of governmental guidelines and laws regulating biomedical technology. Although this rush of guidelines exemplifies a heightened awareness concerning ethical standards for healthcare research, it also invites several practical, political, and procedural problems.
Background In Japan, discussion concerning advance directives (ADs) has been on the rise during the past decade. ADs are one method proposed to facilitate the process of communication among patients, families and health care providers regarding the plan of care of a patient who is no longer capable of communicating. In this paper, we report the results of the first in-depth survey on the general population concerning the preferences and use of ADs in Japan. Method A self-administered questionnaire was sent (...) via mail to a stratified random sampling of 560 residents listed in the residential registry of one district of Tokyo, Japan (n = 165,567). Association between correlating factors and specific preferences toward ADs was assessed using contingency table bivariate analysis and multivariate regression model to estimate independent contribution. Results Of the 560 questionnaires sent out, a total of 425 participants took part in the survey yielding a response rate of 75.9 %. The results of the present study indicate that: 1) the most important components to be addressed are the specifics of medical treatment at the end of life stage and disclosure of diagnosis and prognosis; 2) the majority of participants found it suitable to express their directives by word to family and/or physician and not by written documentation; 3) there is no strong need for legal measures in setting up an AD; 4) it is permissible for family and physician to loosely interpret one's directives; 5) the most suitable proxy is considered to be a family member, relative, or spouse. Multivariate analysis found the following five factors as significantly associated with preferences: 1) awareness regarding living wills, 2) experience with the use of ADs, 3) preferences for end-of-life treatment, 4) preferences for information disclosure, and 5) intentions of creating a will. Conclusions Written ADs might be useful in the Japanese setting when the individual either wishes: 1) to not provide a lot of leeway to surrogates and/or caregivers, and/or 2) to ensure his or her directives in the cases of terminal illness, brain death, and pain treatment, as well as regarding information disclosure. (shrink)
Background Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan. Methods This study consisted of four national surveys sent twice over a period of eight years to two separate (...) samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses. Results Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees. Conclusion Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees. (shrink)
This is the first book to bring West and East together in a broad investigation of contemporary bioethics. A distinguished international team of experts presents original research addressing issues that emerge from new medical technologies, address global challenges arising from social change, and set the agenda for the future.
The ethical tension in childhood vaccination policies is often framed as one of balancing the value of choice with the duty to protect. Because infectious diseases spread from person to person, unvaccinated children are usually described as putting others around them at risk, violating a perceived right to be protected from harm. Editors of Lancet Infectious Diseases recently argued against mandatory vaccination, reminding us that the resort to mandatory vaccination as a means of achieving high vaccination rates is still very (...) much a topic of Western vaccine debates. The nation of Japan offers an interesting case study in childhood vaccination policy, as it has an entirely voluntary system that achieves high vaccination rates. In this paper, we offer an overview of Japanese childhood vaccine policy, suggest some ways to contextualize and understand how a voluntary system achieves high vaccination rates, and speculate on what the future of Japanese vaccination policymaking and government–public relations may hold. (shrink)
Until recently, many of Japan's medical and bioethical communities had ignored the issue of conflicts of interest . This is no longer the case. Discussion on the economic and ethical problems defined by CIs is now apparent in academic, political, and even industrial spheres. In June 2004, this debate was sparked by a scandal involving AnGes MG, Inc., a bioventure company set up by a faculty member at Osaka University Graduate School of Medicine. AnGes MG developed a gene therapy using (...) the Hepatic Growth Factor for obstructive blood vessel disease. Japanese newspapers reported that “several physicians involved with clinical trials for AnGes obtained unlisted shares of stock. One physician allegedly received 32 million yen after AnGes MG went public on the ‘Mothers’ stock exchange”. (shrink)
Public satisfaction with policy process influences the legitimacy and acceptance of policies, and conditions the future political process, especially when contending ethical value judgments are involved. On the other hand, public involvement is required if effective policy is to be developed and accepted.
In der modernen Medizin kommt es zunehmend zu Entscheidungskonflikten zwischen Intervention und Interventionsverzicht dort, wo nicht die medizinisch-technischen Möglichkeiten handlungsleitend sein sollen, sondern die am individuellen Patientenwohl sich orientierende bioethische Prognose entsprechend den klassischen arztethischen Prinzipien des primum nil nocere und des salus aegroti suprema lex. Schadensverbot und Heilauftrag sollen nicht heteronom und uniform vorgegeben werden, sondern sich am Willen des Patienten orientieren. Nicht selten macht jedoch die Ermittlung des mutmaßlichen Patientenwillens große Schwierigkeiten, vor allem bei Demenz, Koma, schwerem Trauma (...) und Multimorbidität in der Nähe des Todes. Vorsorgliche Betreuungsvollmachten und Behandlungsverfügungen, fälschlich oft 'Patiententestament' genannt, sind als Instrumente für stellvertretende Entscheidungen und zur Ermittlung des Patientenwohles in solchen Situationen vorgeschlagen worden. Der Beitrag analysiert die entscheidungstheoretischen, ethischen, rechtlichen und medizinischen Aspekte prospektiver Entscheidung über eine medizinische Behandlung in einem transkulturellen und interdisziplinären Vergleich von Entscheidungen und Diskussionen in den USA, Japan und der Bundesrepublik Deutschland. Es werden verschiedene Modelle und Betreuungsverfügungen mit unterschiedlicher rechtlicher und medizinischer Validität und Präzision sowie unterschiedlicher kultureller und individueller Akzeptanz entwickelt und diskutiert. (shrink)
I am an M.D/Ph.D. student and work as a research assistant for the director of a division of the school of medicine who is an M.D. He assigned me to research a certain topic and gave me no guidelines or guidance as to how to do it. Nevertheless, I did the research and wrote it up. My supervisor liked the report and said that he thought it was so good that “I would like to offer you the opportunity to publish (...) it and list you as the primary author.” Some bells went off when he so grandly offered to let me author the report for which I had done 100% of research and writing. I consulted some other people in the field and they said that, as long as I was the primary author, it was legitimate for him to list himself as secondary author if he did some editing later. After editing the abstract only, he e-mailed his revisions to me and in a note at the bottom he asked me what I thought of his revised author order. His name was first, mine second, and the name of his girlfriend was third. I was shocked by what seemed to be a case of unethical author attribution and confronted him asking why he changed the order when we had agreed that I was primary author. He said that he had put in several hours of work. (shrink)
Scientific misconduct can jeopardize scientific progress and destroy the credibility and reputation of academic institutions and their faculty and students; ultimately it can compromise scientific integrity and result in a loss of confidence for the entire scientific community. Only recently in Japan has scientific misconduct become a central public topic. This increased attention to the topic, in turn, has highlighted a paucity of ethical standards within the Japanese scientific community and a lack of an apt process for conflict resolution. In (...) this brief report, we first provide an overview of several high-profile cases of scientific misconduct recently uncovered in Japan. Next we consider how a recent rise in competition within the academic and scientific communities is possibly related to a concurrent increase in reported cases of scientific misconduct. Last, after discussing what actions have already been taken, we recommend further actions needed to deal with the problem of scientific misconduct in Japan. (shrink)
In this article, we perform a thought experiment about living donor kidney transplantation. If a living kidney donor becomes in need of renal replacement treatment due to dysfunction of the remaining kidney after donation, can the donor ask the recipient to give back the kidney that had been donated? We call this problem organ restitution and discussed it from the ethical viewpoint. Living organ transplantation is a kind of ‘designated donation’ and subsequently has a contract-like character. First, assuming a case (...) in which original donor wishes the return of the organ which had been transplanted into B, and the original recipient agrees, organ restitution will be permissible based on contract-like agreement. However, careful and detailed consideration is necessary to determine whether this leaves no room to question the authenticity of B’s consent. Second, if B offers to give back the organ to A, then B’s act is a supererogatory act, and is praiseworthy and meritorious. Such an offer is a matter of virtue, not obligation. Third, if A wishes B to return the organ, but B does not wish/allow this to happen, it is likely difficult to justify returning the organ to A by violating B’s right to bodily integrity. But B’s refusal to return the donated organ cannot be deemed praiseworthy, because B forgets the great kindness once received from A. Rather than calling this an obligation, we encourage B to consider such virtuous conduct. (shrink)
In the January edition of the Journal of Medical Ethics, Fujita and Tabuchi responded that we misunderstood the ‘facts’ in our previous article. Our article’s method was twofold. First, it appealed to normative analysis and publicly accessible materials, and second, it targeted a policy-making approach to public funding. We specifically did not focus on the Center for iPS Cell Research and Application or induced pluripotent stem stock projects. The Authors raised five criticisms, including transparency of our interpretation of public funding (...) policy. We reply to these criticisms by clarifying facts, and demonstrating new data, and asking the Authors what qualifies as a ‘good fact’ in medical ethics. We note that in some cases, it might be possible to examine to what extent facts are ‘true’, while in other cases, ‘facts’ are laden with ‘values’, which cannot be confirmed or falsified with observation alone. The level of ‘good’ implicit in a fact is a challenging issue that goes well beyond science and makes metaethical assumptions about the relationships between facts and values more broadly. (shrink)
In 1997, after long social debates, the Japanese government enacted a law on organ transplantation from brain-dead bodies. Since 1993, on gene therapy, administrative agencies have issued a series of guidelines. This study seeks to elucidate when people became aware of the issues and when they formed their opinions on organ transplant and gene therapy. At the same time, it aims to examine at which point in time experts, those in university ethical committees and in academic societies, consider these technologies (...) became accepted among the public. A self-administered questionnaire was sent by mail to a stratified random sampling of 3000 people nationwide in Japan. Another questionnaire was sent both to the member societies of the Japanese Association of Medical Sciences and to the ethical committees of all the medical schools in Japan. Results of the surveys indicated that many of the public remained undecided on the desirability of organ transplant or gene therapy at the time of enactment of official guidelines. A substantial part of them formed their opinions in subsequent periods, especially around the time of first implementation and thereafter. Experts of the academic societies and of the university ethical committees regarded the time of implementation as an important factor in the acceptance of the technologies in society. Since many people formed their opinion during the period of technological implementation, communications efforts to facilitate public understanding of science and technology, as well as to advance practical discussion on policy alternatives in this period can play a key role in determining the fate of technological innovation and ethical debates in medicine. (shrink)
Japan is one of several East Asian countries that share an ethical system of mutual support. A review of Japan’s health care system reveals a strong egalitarian ethos often considered unique by outside observers.
Japan is one of several East Asian countries that share an ethical system of mutual support. A review of Japan’s health care system reveals a strong egalitarian ethos often considered unique by outside observers.
Informed consent, decision-making styles and the role of patient–physician relationships are imperative aspects of clinical medicine worldwide. We present the case of a 74-year-old woman afflicted with advanced liver cancer whose attending physician, per request of the family, did not inform her of her true diagnosis. In our analysis, we explore the differences in informed-consent styles between patients who hold an “independent” and “interdependent” construal of the self and then highlight the possible implications maintained by this position in the context (...) of international clinical ethics. Finally, we discuss the need to reassess informed-consent styles suitable to the needs of each patient regardless of whether he or she resides in the United States or in Japan. (shrink)
BackgroundPrevious studies have found that the decision-making process for stored unused frozen embryos involves much emotional burden influenced by socio-cultural factors. This study aims to ascertain how Japanese patients make a decision on the fate of their frozen embryos: whether to continue storage discard or donate to research.MethodsTen Japanese women who continued storage, 5 who discarded and 16 who donated to research were recruited from our infertility clinic. Tape-recorded interviews were transcribed and analyzed for emergent themes.ResultsA model of patients’ decision-making (...) processes for the fate of frozen embryos was developed, with a common emergent theme, “coming to terms with infertility” resulting in either acceptance or postponing acceptance of their infertility. The model consisted of 5 steps: 1) the embryo-transfer moratorium was sustained, 2) the “Mottainai”- embryo and having another child were considered; 3) cost reasonability was taken into account; 4) partner’s opinion was confirmed to finally decide whether to continue or discontinue storage. Those discontinuing, then contemplated 5): the effect of donation. Great emotional conflict was expressed in the theme, steps 2, 4, and 5.ConclusionsPatients’ 5 step decision-making process for the fate of frozen embryos was profoundly affected by various Japanese cultural values and moral standards. At the end of their decision, patients used culturally inherent values and standards to come to terms with their infertility. While there is much philosophical discussion on the moral status of the embryo worldwide, this study, with actual views of patients who own them, will make a significant contribution to empirical ethics from the practical viewpoint. (shrink)
In April 2018, Japan’s first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law’s application brings numerous complications, (...) including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field. (shrink)
Compared to institutional and area-based ethics committees, little is known about the structure and activities performed by ethics committees at national medical organizations and societies. This five year follow-up study aimed to determine (1) the creation and function of ethics committees at medical organizations in Japan, and (2) their general strategies to deal with ethical problems. The study sample included the member societies of the Japanese Association of Medical Sciences (n=92 in 1998, n=96 in 2003). Instruments consisted of two sections: (...) (1) the structure, function and activities of ethics committees, and (2) the strategies for dealing with ethical problems. Response rates were 84.4% in 1998 and 64.4% in 2003. Findings showed a significant increase of ethics committees at medical organizations between 1998 (25.6%) and 2003 (50.0%). Members were mostly male, medical doctors in clinical or basic medicine, and members of the organization. The major functions of ethics committees were ethical reviews of research protocols, policy making and ethical reviews of manuscripts submitted for journal publication. Among organizations that did not have an ethics committee, a significant decrease was found in organizations that replied that they had never experienced an ethical problem which needed further investigation (p<0.01). Findings suggested an overall rise in awareness of the importance of ethical issues and also highlighted an increase in recognition of responsibility regarding ethical problems. (shrink)