Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

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In recent years, research ethics committees （REC） in Japanese institutions have been receiving applications for research, which are not regulated by administrative policies or laws. Appropriate handling of such applications is extremely important with regard to the sound operation of REC. In the present study, we conducted a questionnaire-based survey that clarifies the content of applications for nonregulated research and its reasons, as well as the ethics committees' handling thereof, to serve as a basis for creating a method for appropriate handling of such applications. The results demonstrate that 60％ of the responding institutions had examined applications for nonregulated research. The contents of the applications were roughly divisible into case reports and nonmedical research fields, such as psychology, pedagogy, and sociology. Furthermore, the main reason for application was that such research works were required as a paper submission or for a conference presentation. However, the rules of the academic association failed to clarify the standards for research to be handled by REC. Consequently, it is possible that a large number of applications that should not have undergone examination are being examined. This context is apparently reflected in the fact that approximately 70％ of institutions adopted a simplified examination method in reviewing applications for nonregulated research. However, this method for handling nonregulated research applications is problematic both in the usage of scarce resources and the lack of sufficient consideration given to applications that actually require examination by the committee. To improve this situation, academic associations must indicate standards for research requiring examination, whereas REC must independently judge whether or not examination is required and decide on what examination methods are appropriate to use.

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