Practice of legal medicine in Japan: Informed consent in research

Abstract

In Japan, like many other countries, the doctrine of informed consent has been firmly established in clinical practice and research. This chapter describes the developments, in Japanese law and administrative regulation, concerning the doctrine in the setting of clinical research, in which two types of research are included, namely, (A) research conducted to obtain the evidence submitted to the Ministry of Health, Labour and Welfare (MHLW) for its approval of new drugs or medical devices and (B) that conducted without reference to the MHLW’s approval. Type (A) research is governed by the Good Clinical Practice (GCP) regulations, and type (B) research is by the ethical guidelines promulgated by the administrative departments. The informed consent for research, it is often argued, must be tailored to each specific research proposal. In research utilizing specimens left over after completion of preceding research or laboratory tests, or those collected from body parts removed for the treatment of the patient, as well as the research using specimen donated to biobanks, it is difficult to give information regarding specific research in the stage of collection. To cope with the situation, the concept of broad consent and the waiver of consent requirement by the research ethics committee have been proposed. This chapter argues in favor of the broad consent rather than the waiver of consent requirement. As a prelude, the chapter presents the general view of the requirements of informed consent in the setting of clinical practice and our governance system of clinical research.