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)

This research examines the current status of clinical ethics consultation (CEC) in Japan through a nationwide study conducted with chairs of ethics committees and clinical ethics committees among 1028 post-graduate clinical teaching hospitals. We also qualitatively analyzed their viewpoints of the CEC’s benefits and problems related to hospital consultation services to identify the critical points for CEC and inform the development of a correctly functioning system. The questionnaire included structured questions about hospital CEC organization and service purpose and operation and (...) open-ended questions about the benefits and problems of initiating CEC. The questionnaire comprised the presence/absence of an ethics committee, CEC services and membership when services were implemented, users, and the number of cases handled since inception. In addition, the respondents also provided their impressions of the CEC system’s impact on their hospital by describing (a) the benefits of CEC services and (b) the ineffectual or harmful aspects of the CEC system. Qualitative data were examined using qualitative content analysis to determine the impact of establishing a CEC and the difficulties of practice. One hundred twenty-five questionnaires were returned from either the chair of the ethics committee or clinical ethics committee in teaching hospitals. Of these, 90 (72%) reported they provided CEC services. Additionally, 36 respondents (34.6%) reported that their existing research and clinical ethics committees had conducted CEC services, and 35 (33.7%) reported having a newly established clinical ethics committee conducting CEC services. Three positive effects of establishing and four challenges in managing CEC were also identified. (shrink)

Hospital ethics committees (HECs) are expected to play extremely broad and pivotal roles such as case consultation, education of staffs on healthcare ethics, and institutional policy formation. Despite the growing importance of HECs, there are no standards for setup and operation of HECs, and composition and activities of HECs at each institution are rarely disclosed in Japan. In addition, there is also a lack of information sharing and collaboration among HECs. Therefore, the authors established the Consortium of Hospital Ethics Committees (...) (CHEC) in October 2020, which has been regularly hosting a couple of core activities. One is the Healthcare Ethics Forum, held monthly online for CHEC members to freely discuss HECs and healthcare ethics consultation. The other is the Collaboration Conference of Hospital Ethics Committees, intended to provide a place for HEC members and administrative officers from across Japan to exchange information of their HECs, learn from each other, and cooperate to operate HECs appropriately. In this paper, the authors introduced CHEC as well as reported the results of a questionnaire survey conducted at the first conference among participating facilities, suggesting the diverse structures and activities of HECs in Japan. (shrink)