2022 年 53 巻 5 号 p. 177-188
The Japanese research ethics guidelines titled, “Ethical Guidelines for Medical and Biological Research Involving Human Subjects” regulate for collective review. Research and medical institutions now employ internal ethical review systems to conduct reviews. At Kyoto University, the graduate school and faculty of medicine of the ethics committee office has utilized a central collective review system (central REC system) since the establishment of the previous guidelines. The present study details the current status of the central review system and its issues and their potential solutions, based on practical experience of the first author (Kitao) at Kyoto University ethics committee office before and after the implementation of the current guidelines.
The transition to the new research ethics guidelines eliminates the intervention of institutional authorities who are not directly involved in the review process, but further burdens principal investigators, who are now required to collect and submit the confirmation of institutional requirements of collaborating institutions.
The distinct features of the future review system, from the perspective of the Ethics Review Committee Secretariat, are described below.
（1）Changing the review procedure according to the type of research.
（2）Strengthening the research secretariat.
（3）Clarifying and distinguishing the roles of the head of the institution and the Ethical Review Committee.
In future, ethical review procedures should also be evaluated to ensure the true ethicality of clinical research, where researchers are not subject to arbitrary procedures and can focus on the safety and due respect of the research participants.
