大学の倫理審査委員会による非医学研究に対する事前規制

抄録

The primary purpose of the Institutional Review Board (IRB) is to protect the rights and welfare of human subjects in medical research. IRB approval for non-medical research in areas such as social and behavioral sciences is also required at some universities, although this research is exempt from governmental regulation in Japan. This paper will discuss the need for IRB’s prior approval for non-medical research from the academic freedom perspective. Analysis of the risk to human subjects and outcomes of IRB approval was conducted using the minutes of IRB meetings at universities published by the Ministry of Health, Labour and Welfare. While many of the non-medical research proposals could be characterized as posing less than minimal risk to the participants, those proposals were not easily approved. This study suggests the development of less restrictive alternatives to manage and control non-medical research projects.