Activities around the JSMBE Guideline under Clinical Trials Act of Japan

Abstract

The Clinical Research Act enforced in April 2018 states that only those with a doctor's license can carry out clinical research. Therefore, to clarify whether a research is categorized as clinical research or not is quite important issue for biomedical engineering researchers. In October 2019, JSMBE issued guideline to Classify Biomedical Engineering Research under the act. In this guideline, the two conditions of 1) not including prevention / diagnosis / treatment and 2) not affecting the structure or function of the body are used as criteria. Since detailed judgment criteria of condition 2 may differ, it is required to create an attached table to show the criterion for each individual field. In this panel discussion, we will discuss how the activities can affect the ongoing amendment of the act with an MHLW personnel.