A survey of informed consent in patients with dementia in the US and Japan.

This study aimed to confirm the reality of family-focused medical treatment of dementia in Japan and the US. It conducted a questionnaire survey on informed consent from patients with dementia among neurologists and psychiatrists in four prefectures in the Tokai Region (Aichi, Gifu, Mie, and Shizuoka) and dementia specialists in the US. Of the responses, 120 (39.7% response rate) and 20 (5.9% response rate) were obtained, respectively. In obtaining informed consent from patients with dementia, 75 Japanese specialists (62.5%) and 16 US specialists (80.0%) regularly assessed patients' decision-making abilities. The majority of specialists in both Japan and the US used the Mini-Mental State Examination and Hierarchic Dementia Scale-Revised, which are widely used for cognitive function assessment. In the survey, 27 Japanese specialists (22.5%) and 10 US specialists (50.0%) had different considerations when obtaining informed consent for participation in research, compared to their medical practice. The majority of Japanese and US specialists obtained informed consent from both the patient and their family.

Issues concerning life-prolonging treatment in Japan, as considered from attitudes among the legal and medical professions.

In this paper, the author explores the clinical ethical issue of the withdrawal and withholding of life-prolonging treatment, surveying 2,848 lawyers and 2,469 doctors as medical and legal professionals in Japan on a variety of points for discussion. The main survey items are: (1) systems that should be used in the withdrawal and withholding of life-prolonging treatment at the end of life; (2) problems in determining treatment strategy at the end of life; (3) assessment of suspension of life support systems (extubation); and (4) strategies for better end-of-life care. While 42.2% of lawyers cited legislature and judiciary and 54.9% cited academic society guidelines as the system that should respond to the withdrawal and withholding of life-prolonging treatment, 23.3% of doctors cited the legislature and the judiciary, and 65.4% academic society guidelines. In relation to current end-of-life care, 81.3% of lawyers and 69.3% of doctors responded that there was room for improvement. Strategies for doing so included ensuring the transparency of and publishing decision procedures, and notification to government. It is important for medical institutions to normalize end-of-life care by making decisions with reference to guidelines and the like, ensuring the transparency of decision-making procedures, and being managed by a public institution.

The status of central ethical reviewing and challenges regarding its introduction to non-interventional studies in Japan.

In 2018, we conducted a study on 121 ethics review committee offices in Japan to examine the state of "central review" in non-interventional studies and discern any challenges regarding its introduction. Of the 452 offices that were invited to participate, 121 responded (26.8% response rate), and 35 (28.9%) had records of furnishing contracting agreements with ethical reviews by other research institutions. The merits of central reviewing include easing the burden on ethics review committees, improving the quality level and consistency of ethical reviews, and enhancing the efficiency in conducting them. The demerits include increased administrative overheads and work for researchers, such as preparing application forms and checking institutional requirements, and a lack of clarity regarding who is responsible for conducting the research, which makes it is less desirable for institutions to have their own ethics review committees. This study revealed that the comprehensive introduction of central review in non-interventional studies continues to encounter many hurdles, and promoting central review requires overcoming these challenges one at a time. The Ethical Guidelines for Medical and Health Research Involving Human Subjects will be revised in 2021 to require central review as a part of ethical reviews for non-interventional studies. In the future, central reviews of non-interventional studies will need to be of high quality and conducted efficiently, and this will require research institutions to utilize relevant central review guidelines and checklists.

Support Systems for Medical Decision-Making: Considerations for Japan.

Clinical issues involving ethical dilemmas arise daily and confound physicians as they provide medical care. These dilemmas require difficult decisions as physicians must respect patients' values, lifestyles, and freedom of choice while protecting life and promoting health. This is made more challenging as values and lifestyles become more diverse, making third-party support necessary to accommodate the wishes of stakeholders, particularly patients. Collaborative work is important for addressing clinical ethics issues. Government agencies and professional organisations should discuss individual cases as public policy concerns and release guidelines based on their deliberations. Medical institutions should refer to such guidelines in their own discussions on ethically challenging cases. This is not the case today as each organisation creates its own guidelines; there is no consensus on how clinical ethics committees or consultations should be conducted. Support systems that are public in nature are needed to protect patients' rights and freedoms in medical care.

The ethics of blood transfusion refusal in clinical practice among legal and medical professions in Japan.

We investigated the differences in Japanese and United States medical and legal professional opinions on ethical support for clinical ethical issues using the refusal of blood transfusions on the grounds of religious principles as an example of a clinical ethical issue. In ethical support systems for medical institutions in Japan, 95.0% of "clinical training designation hospitals" have hospital ethics committees, and 63.1% have medical safety divisions; clinical ethical support is provided in accordance with their scale and function. In terms of clinical ethical support limits the discretion of physicians, 59.2% of lawyers responded "No" and 54.4% of doctors responded "Yes". In addition, on the feasibility of government or academic guidelines in clinical practice, 37.7% of lawyers responded "Yes" and 63.0% of doctors responded "No". In terms of "relative transfusion-free" policy, 83.2% of lawyers and 76.8% of doctors responded that it is "unavoidable," while 81.6% of U.S. committee heads responded that it is a "violation of rights." In terms of hospital transfers due to a hospital being unable to treat patients refusing blood transfusion, 62.6% of lawyers reported that it is "unavoidable" while 57.1% of U.S. committee heads reported that it "should be avoided". The results of this study indicate that medical and legal professionals and U.S. ethics committee heads recognize clinical ethical issues in slightly different ways.

An overview of ethical review committees in Japan: examining the certification applications of ethical review committees.

The survey involves examining the applications from 142 institutions that have consented to make available all certification applications from 2015 and 2016 to a research project for building a certification system for an ethics committee run by the Agency for Medical Research and Development. The number of certified institutions is 20 (14.1%). In the applications from uncertified institutions, there are cases in which requirements of ethics guidelines are unmet, and there is insufficient information provided on regulation and procedure. An analysis of the committee members who can contribute as members of the general public (general public committee members) has indicated that the number of committee members who do not belong to an institution in which an ethics committee is instituted (external committee members) is 41 (95.7%) among the certified institutions and 224 (84.5%) among the uncertified institutions. The proportion of general public committee members drawn internally from institutions tends to be higher among uncertified institutions. While a separate committee examined conflicts of interest in research in 19 certified institutions (95.0%), such conflicts were found in 41 uncertified institutions (33.9%) by the ethics committee. The survey confirms that the challenge lies in increasing the number of external committee members and in further improving the system to manage conflicts of interest, and the education and training regime.

[Ethical guidelines for clinical studies: overview].

Clinical research is guided by ethical principles promulgated in several statements, principally the Nuremberg Code, the Helsinki Declaration of the World Medical Association etc. In Japan, clinical research of medical products, principally trial of new pharmaceutical products is regulated by GCP (good clinical practice). Other types of clinical research are regulated by some ethical guidelines for clinical researches. The result is a regulatory position that is a complex combination of legislation and ethical guidelines. In the Ethical Guideline for Clinical Studies revised in 2008, clinical research is classified into intervention research and observational research. When researchers plan clinical research, they must determine the type of clinical research and appropriate ethical guideline for the type of clinical research. Advances in health informatics and genetic research have produced a new and very rich body of raw material for clinical research in the form of gene banks and genome-wide association study etc. The use of human tissue and medical information in the course of clinical research raises issues under the ethical regulations for research with human subjects.

Risk disclosure in securities exchange and medical treatment contracts.

The duty of risk disclosure in medical treatment contracts is examined first through comparison with securities exchange contracts, second, by examining the contract as dealt in judicial precedent, ensued by an analysis and proposal by the author. In both types of contracts, the number of judicial judgments finding for the plaintiff based solely on violation of the duty of risk disclosure is increasing. Different explanations, however, should apply for the increase. In the case of the securities exchange contracts, the duty to inform is understood as a means of providing material for informed choice and self-determination, thus supporting the argument for self-discipline. Whereas, in the case of medical treatment contracts, adding to the argument for self-determination, another line of reasoning is given: disclosure of relevant information as a means by which the medical services secure the life and physical well-being of the patient. The reason the principle of self-determination is not in full play is analyzed as a case in which higher norms of the professional ethics of the medical staff is functioning. Thus, in providing medical information of possible treatments to the patient, the physician is exonerated from legal liability, but remains burdened with the ethical responsibility to provide appropriate care. As the overlap of the two types of responsibility seems not to be fully realized, further investigation and dissemination of findings of this issue is proposed.