Making possible the easy and effective modification of genes, genome editing has become an indispensable tool for basic and applied medicine and life sciences. Since 2015, when a research paper describing basic research work on genome editing in human embryos was published, there has been extensive discussion on the use of the technology in humans. In particular, the question regarding whether the technology can be applied to the human germ line through which modified genes are passed on to the next generations has been hotly debated. In this article, by analyzing various events and discourses during this period, I have attempted to highlight and examine some crucial issues and lessons for the future. During the analysis, it became clear that, while the scientific community played an important role in stimulating public discussions, its self-regulation was not sufficient to prevent incidents like the birth of twin babies through genome editing. In the future, it will be crucial to deepen more interdisciplinary and global scale discussions through the participation of non-medical and scientific specialists, citizens, patients etc. Bioethicists and ELSI (Ethical, Legal and Social Issues or Implications) specialists are also expected to play an important role in facilitating such discussions.

　　At the 31^st annual meeting of the Japan Association for Bioethics in 2019, an open public forum, entitled “A dialogue with citizens on genome editing technology of human embryos,” was held. As a liaison member between experts and citizens, I offered my opinions on the matter, dividing the matters of expected spread of the technology and relevant issues into three sections. First, in the phase of basic medicine/preclinical studies, during which no one is born using this technology, the main issues are research integrity and assessment of safety and accuracy of the technology. The next anticipated phase comprises clinical trials and treatment, and a genetically edited baby would be born using this technology. Ethical issues that would need to be addressed during this phase would include the protection of research participants and ensuring that fair medical practices are maintained. Discussion on the moral status of the human embryo may also need to be revisited in this phase. In the third phase, the technology goes beyond medical practice and is made more accessible. The births of many designer babies could influence human relationships, individual lives, and our community structure, in massive and complicated ways. In order for us to accept and ensure that this technology becomes widespread in the future, a multidisciplinary and collaborative approach is necessary.

　　This study aimed to discuss genito-pelvic pain/penetration disorder, a female sexual dysfunction detailed in DSM-5, from a medical safety perspective. In particular, this study sought to address the ethical issues believed to be faced by the behavior therapy treatment method specific to this field. Currently, behavior therapy is the mainstream form of treatment in Japanese gynecological care. In DSM-5, the diagnosis of this disorder does not include, for the time being, the effects of various problems that can be successfully explained by non-sex-related mental disorders and other stressors. However, at present, subtle signs of non-sex-related mental disorders and other stressors may be overlooked in gynecological care, where this disorder is mainly treated. Such a tendency may lead to further deterioration of a patientʼs condition or cause the development of a secondary disorder. Therefore, we re-evaluated sexual dysfunctions from a traditional psychoanalysis standpoint, starting from the concept of Borderline／la psychose ordinaire lacanianne in the proper psychoan alytical sense. Next, we present the dangers of treatments biased toward behavior therapy specific to the gynecology medical field, which is the current mainstream treatment being given in Japanese gynecology medicine and propose a counterplan for the advancement of safer treatment.

　　This paper highlights some legal issues stemming from the refusal of medical treatment for patients who refuse blood transfusions. Ever since the Supreme Court decision regarding forced blood transfusion (2000), there has been a worrying trend against respecting patients' rights. Under the name of “relative bloodless treatment”, some hospitals are avoiding even the treatment of patients unless they sign consent for blood transfusion. Such a trend violates the patients' right to self-determination, runs counter to the purpose of Article 25 of the Constitution protecting the right to life (which is the basis for the Medical Practitioners' Act), and violates the duty to provide medical treatment and the duty of patient transfer. From the guidelines as set out by the notice of the Ministry of Health, Labour and Welfare issued on 25 December 2019, the only time a denial of treatment can be justified when a patient in a severe condition refusing blood transfusions is requesting treatment during consultation hours, is when treatment is virtually impossible. This paper outlines ways doctors should respond rather than issuing a blanket refusal of treatment.

　　In this paper, 437 clinical ethics consultation cases handled at our hospital in the past 6 years were subjected to 4-step coding by referencing the SCAT method, a qualitative research method. We focused on the themes and concepts shared across various cases and defined these as “key terms.” The following 9 key terms were extracted: “off-label medical treatment” (207 cases), “use of unapproved drugs” (33 cases), “conflicting treatment strategies” (32 cases), “interacting with patients who have no relatives” (14 cases), “withholding treatment” (11 cases), “mental support for physicians” (10 cases), “withdrawing treatment” (9 cases), “support for family” (7 cases), and “protection of personal information” (6 cases). While the 7 classifications created based on explanations of the Japan Council for Quality Health Care in “Approaches to Evaluation” set external scenarios in which ethical problems are expected to be encountered, the present 9 key terms are thought to present a part of the internal dilemmas faced by medical professionals.

　　Over the last decade, quite a few misconduct cases have been reported internationally and domestically, particularly involving perjured statements of research ethics approval (REA) in clinical research manuscripts. Unfortunately, because such cases were relatively few in number, and because the issue of perjury was masked by other, more pressing misconduct issues such as fabrication, falsification, and plagiarism, the field of research ethics paid little attention to the severity of this form of fraud. To address this matter, the present study has examined several reported cases and investigated ethical issues in misstatements of an REA in clinical research.

　　In the field of research ethics, various approaches have been taken to discuss and inquire about ethically relevant matters in clinical trials. However, it has been the researchers, and not the participants in the clinical trial, who have identified the problems in the clinical trial. The present paper takes the opposite approach in order to discuss ethical problems in ongoing clinical trials from the perspective of the participant. To clarify, one of the authors of this paper has taken part in a clinical trial (trial X), so the perspective from which clinical trial problems are examined are based on the author/researcher's own experience as a participant in the clinical trial. This paper identifies the following problems: (1) missed harm to the subject, (2) therapeutic misconceptions, (3) unfair distribution of burden, and (4) opacity of research ethics committee. (1) During the clinical trial and the required wash-out term, research subjects are generally deprived of access to standard medical care. However, since this deprivation-harm is hidden by secondary effect harm of experimental treatment, it is hardly ever included as harm to the subject. (2) The physician of trial X seemed to hold a “therapeutic misconception”— i.e., an invalid confusion of trial with therapy. But this misconception may have been induced by the environment within the clinic itself. In addition, some expressions used in the clinical trial, such as “trial drug” or “new therapy,” definitely work to cause therapeutic misconceptions among both physicians and subjects. (3) During trial X, participants are asked to pay money each time they visit the clinic. The principle of justice would deem this an unfair burden on subjects. As human subjects are disproportionately exposed to risks and burdens, particularly physical ones, no further burden should be imposed on subjects. (4) The research ethics committee displayed insufficient transparency in their examination of the trial X protocol. The outline of the meeting minutes accessible to subjects simply states, “examined the propriety.” The present paper discusses these issues concerning ongoing clinical trials.

　　Clinical ethics consultation is an advisory service designed to assist patients, families, and health care professionals in resolving ethical dilemmas. Ethics support services have increased in Japan recently, although the actual activity involved in clinical ethics consultation has rarely been reported upon. In this study, we review our institutional experiences in 74 clinical ethics consultations conducted between August 2016 and May 2019. We also summarize previous Japanese institutional reports of clinical ethics consultation and discuss ideas for making clinical ethics consultation sustainable. The Japan Council for Quality Health Care's evaluation of hospital management has strengthened the installation of clinical ethics consultation, but sustainable activity is economically limited. Based on our research, we propose adopting medical fees for clinical ethics consultation.

　　The Ethical Guidelines for Medical and Health Research Involving Human Subjects calls for “special consideration for vulnerable subjects.” This principle has yet to be examined in detail. Questions remain, such as, what defines a subject as vulnerable? What does special consideration involve? Research ethicists have discussed the meaning of “vulnerability” and “vulnerable groups” for the past two decades, but Ethical Guidelines use little from the discussion. Consequently, the protections for vulnerable subjects laid out in the Guidelines are problematic. This article offers three steps to improve the medical and health research regulations and practices in Japan. First, the history of vulnerability in research ethics is traced back to its original context and premise. Second, three promising approaches to the concept of vulnerability are examined. Finally, relevant conditions in Japan are highlighted to demonstrate the need for a supplementary ethical document regarding special protections for vulnerable subjects. The supplementary document should be analytical and concrete.