Challenges to the development of the ethical review of human subject research in Japan

Over the past forty years, bioethicists, policy makers, researcher and others have established ethical standards for human subject research, such as those articulated in the Declaration of Helsinki, promulgated by the World Medical Association. For example, there is near universal agreement among experts globally about foundational principles, such as respect for the rights of individual research subjects, and expectations for oversight, such as a requirement for prospective, independent review of research protocols. Nevertheless, what happens in the actual conduct of research may fail to adhere to these expectations and standards. The purpose of this paper is to examine some of the historical and social factors that have affected the implementation of institutionalized human subject research ethics review in Japan. It will describe reasons why the first institutional ethics committee, established to review the first IVF program in Japan, functioned more as a way to build social consensus for this new technology than as a forum for the examination of ethical questions raised by the research. It will also discuss the fact that the population based cancer registry collected information on patients for more than 50 years without ethical or legal review. Even today, in many institutions, a single ethics committee reviews both clinical cases and research protocols. The paper will end with a discussion of changes -- such as a strong, self-regulating medical profession and clear government regulations – that are needed to assure the ethical practice of research and the protection of human subjects in Japan.