介護福祉・リハビリテーション機器開発での臨床研究該当性判断のための別表表示

抄録

This paper aims to publish an appended table for the Clinical Trials Act to decide the applicability of the law to studies on the development of nursing welfare and rehabilitation devices with mechanical loads in human subjects. Under the Clinical Trials Act, the specified clinical trials must have a medical or dental doctor as a representative. If this limitation applies to challenging exploratory research involving human subjects, the majority of researchers other than medical or dental doctors will face difficulties of pursuing their studies under the law. Significantly, researchers should pay close attention to the delicate issue of whether their studies involve performing “medical practice.” JSMBE announced a guideline for judgment of the applicability to clinical trials involving human subjects last year. The appended table in this paper supports researchers who are interested in nursing welfare and rehabilitation studies, especially those of gait, posture and balance, joint motion, and body pressure, to decide the applicability of the law. The authors, then, consider the appended table to show the standards or assessments for universities and research institutes processing large amounts of evidence and data for publication regarding what must be examined.