2016 Volume 26 Issue 1 Pages 4-14
The new national ethical guidelines for medical and health research involving human subjects were enacted in December 2014. The new Guidelines are the first governmental guidelines in which the ethical framework of “risk-benefit assessment” that is internationally recognized as a common normative framework of research ethics has been formally introduced in the Japanese regulatory system. The new Guidelines clearly distinguish “SINSHU” (invasiveness) which causes with certainty, by the Guidelines’ definition, injuries or distress to research subjects’ body and/or mind, from “RISUKU” (risks) which is defined as an uncertain possibility of harm. However, because the new Guidelines’ actual practical scheme of “risk-benefit assessment” is based ex parte on “SINSHU”, it not only has little conformity with the international risk-benefit framework, but also generates regulatory distortions in the human subjects protection and the assurance of integrity and transparency of research. This paper discusses those ethical issues concerning regulatory distortions in the new Guidelines.
