Mini-review and Fact-finding on Non-conformity Reports in Studies Under Ethical Guideline

Takuya Mori, Takuya Watanabe, Shinji Kosugi
Volume 5 Issue 1 Pages 14-21
First Published: July 8, 2022
[in Japanese]



The ethics guidelines stipulated by the government in Japan include provisions that require the ethics review committee to consult with the ethics review committee as “Non-conformity report” for deviations from the guidelines. These are important issues in subject protection, and the judgment of their seriousness is left to the ethics committee, but there is no clear answer such as concrete examples. Therefore, we investigated the systematic review of non-conformity reports and the review status of non-conformity reports by arbitrarily extracted Ethics Committee. As for the results of this study, in the systematic review, there was no paper whose main purpose was to report nonconformity. A multi-case study by the Ethics Committee revealed that the publication of nonconformity report reviews differed significantly between universities, and that at most 2.2% of all new study protocol. From the results of this survey, it became clear that there is very little information on non-conformity reports in Japan, it is suggest that need to activate information on non-conformity reports.


Key words

Ethical guidelines, Ethics committee, Ethical review, Research ethics, Non-conformity report