The Role of Male Consent in Assisted Reproductive Technology Procedures: an Examination of Japanese Court Cases.

With the development of assisted reproductive technologies, medical, ethical, legal, and social issues have arisen that did not exist when natural conception was the only means of childbirth. In Japan, men tend to believe that assisted reproductive technologies are not directly related to them, with the literature showing that men are often reluctant to be involved in fertility treatment processes. To better understand this situation, this study analyzes the role of male consent during assisted reproductive technology procedures in Japan. First, we examined Japanese court cases that dealt with issues related to male consent during assisted reproductive technology procedures and identified three situations in which problems related to male consent during such procedures may arise. Next, we analyzed the background of such issues and the implications of the lack of consent regarding men's reproductive rights. Finally, we explored the need for legislation on assisted reproductive technologies. The study concludes that discussions on the scope of male partner rights in assisted reproductive technology procedures are key for minimizing unnecessary conflict between partners, thus ensuring both the rights of women who wish to have children and the welfare of their children. Supplementary Information: The online version contains supplementary material available at 10.1007/s41649-023-00274-1.

Restrictions on monetary payments for human biological substances in Japan: The mu-shou principle and its ethical implications for stem cell research.

Introduction: Restrictions on financial gains from the sale of human body parts is a leading policy issue surrounding the use of human tissues and cells. However, discrepancies exist between regulations and reality. In stem cell research, in which diverse sources of tissues and cells can be used, unclear regulations can impede research. Thus, using the Japanese system as a case study, we examined the challenges in the implementation of the "no payment" or the mu-shou principle in stem-cell research over the years. Methods: We reviewed 28 Japanese laws and governmental guidelines and summarized the scope of restrictions on payments for the donation and supply of human biological samples (HBS). Results: As part of restrictions on financial rewards, the mu-shou principle emerged in Japanese laws and administrative documents in the 1990s. Although the Japanese mu-shou generally means "free" or "gratis" in English, its interpretation in research and development settings remains ambiguous. Traditionally, this principle was used to deny remuneration to donors. However, it is also inconsistently applied while processing and transferring human tissue after donation, which creates confusion among the various stakeholders. Recent policies have interpreted the principle in multiple ways: (1) treating the use of HBS for cell-processing as a non-profit activity; (2) a flexible interpretation of the principle to broaden the scope of user payments; and (3) removal of the principle itself to allow for commercial use. Conclusions: The inconsistencies in the monetary payment requirements for HBS could hinder research and development. After scrutinizing the principle's background, an effective approach is needed that considers the concerns of the providers, users, and society alike.

Why does it take so long for rare disease patients to get an accurate diagnosis?-A qualitative investigation of patient experiences of hereditary angioedema.

INTRODUCTION: Many patients with rare diseases experience a diagnostic delay. Although several quantitative studies have been reported, few studies have used a qualitative approach to directly examine how patients with rare disease obtain a diagnosis and why it takes many years. In this study, we focused on hereditary angioedema (HAE), which has been reported to have long diagnostic delays, despite the knowledge that not having an accurate diagnosis can cause life-threatening problems. OBJECTIVE: The objective of this study was to analyze patients' experiences and elucidate why it takes a long time to reach a diagnosis of HAE. We also aimed to propose possible solutions for the problem. METHODS: A qualitative study using semi-structured interviews was conducted. Nine patients who took over 5 years from the presentation of initial symptoms to an HAE diagnosis participated. The contents of the interviews were subjected to an inductive contents analysis. RESULTS: By analyzing the patients' struggles that were experienced during the undiagnosed period, three themes were generated: (1) acceptance and resignation towards their conditions, (2) proactive search for a cause, and (3) independent efforts outside of the hospital. While a few patients continued to seek out a diagnosis during the undiagnosed period, many had become accustomed to their health condition without suspecting a rare disease. CONCLUSIONS: We found that one of the most important factors related to the prolonged undiagnosed period is the lack of suspicion of a rare disease by patients and their medical professionals. While current policies tend to focus on the period from suspecting rare diseases to the time of a clear diagnosis, our results strongly suggest that measures are needed to facilitate patients and clinicians to become aware of rare diseases.

Dynamic Consent: An Evaluation and Reporting Framework.

Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher-participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.

Correction to: Ethical Perspectives of Japanese Engineers on Ambient Assisted Living Technologies: Semi-structured Interview.

[This corrects the article DOI: 10.1007/s41649-018-0053-0.].

Ethical Perspectives of Japanese Engineers on Ambient Assisted Living Technologies: Semi-structured Interview.

Ambient assisted living (AAL) technologies are expected to solve a significant number of problems related to elderly care. However, in Japan, limited discourse on the ethical issues concerning their application is hindering the spread of AAL technologies. Against this background, this study explores the ethical perspectives of AAL technology engineers in Japanese companies and the circumstances influencing their perspectives. A qualitative study using semi-structured interviews was conducted. Nineteen Japanese AAL-technology companies were contacted, and nine of them and their engineers responded to the interviews. The contents of the interviews were analyzed with thematic analysis which showed that the engineers had ethical concerns about their products as follows: (1) safety and related conflicts, (2) acceptance of the technology, (3) dependence on the technology, (4) accident liability, (5) fair access to the technologies, and (6) privacy. In relation to these issues, they identified as company employees with regard to the following: responding to social needs, having many users, and cost reduction. They also mentioned being influenced by the Japanese national program for AAL-technology promotion. The engineers experienced dilemmas between the various stakeholders' interests and they hoped that ethical guidelines for developing AAL technologies would resolve such dilemmas. In conclusion, Japanese AAL-technology engineers tackle ethical issues with regard to the application of their products. The engineers hope for the establishment of guidelines for the ethically responsible development of AAL technologies. The guidelines need to be established and implemented in an interactive manner, in order to avoid their being reduced to a bureaucratic formality.

Surrogacy: donor conception regulation in Japan.

As of 2008, surrogacy is legal and openly practised in various places; Japan, however, has no regulations or laws regarding surrogacy. This paper reports the situation of surrogacy in Japan and in five other regions (the USA, the UK, Taiwan, Korea and France) to clarify the pros and cons of prohibiting surrogacy, along with the problems and issues relating to surrogacy compensation. Not only in a country such as France that completely prohibits surrogacy within the country, but also in a country such as the UK that allows non-commercial surrogacy, infertile couples travel overseas for the purpose of surrogacy. In addition, some couples might seek underground surrogacy if the government prohibits surrogacy. If an intended parent couple and a surrogate make an agreement among themselves and then a problem occurs, they cannot ask for support from professionals or bring a case to court, as can be observed in South Korea and Taiwan. We also conclude that there is little difference between commercial surrogacy and non-commercial surrogacy in the absence of a clear definition of 'reasonable expenses.' In the UK, the law does not allow surrogates to receive compensation. However, in reality, there may be little difference between the amounts paid to surrogates for profit in the US and those paid to surrogates for reasonable expenses in the UK. We conclude that the issue of surrogacy demands further discussion in Japan.

Relationship between public attitudes toward genomic studies related to medicine and their level of genomic literacy in Japan.

The aim of this study was to assess public attitudes toward the promotion of genomic studies related to medicine and to examine the relationship between public attitudes and the level of genomic literacy by analyzing data from a nationwide opinion survey. The participants comprised 4,000 people (age, 20-69) selected from the Japanese general population by using the two-step stratified random sampling method. They were queried on the following topics in a mail survey: (1) pros and cons of the promotion of genomic studies related to medicine, (2) level of scientific literacy in genomics, (3) demographic and socioeconomic background, and (4) knowledge and attitudes toward science in general and genetic testing in particular. We examined the relationship between the approval of promotion and literacy level, using logistic regression models stratified by gender. Our results showed the response rate was 54.3% (2,171/4,000), and 69.4% participants favored the promotion of genomic studies related to medicine. Only 1.3% participants expressed a negative attitude. Multivariate analysis revealed that approval of promotion was related to a high literacy score. This relationship was stronger in males than in females (the highest quartile of score vs. the lowest: adjusted odds ratio, 3.36 for males and 1.86 for females; 95% confidence interval, 1.88-5.98 for males and 1.17-2.95 for females). We determined that a majority of the Japanese participants currently approved of the promotion of genomic studies related to medicine and that people with a high level of genomic literacy tended to approve the promotion.