[Ethics Review Committees of Public Health Institutes in Japan].

Abstract

Objectives: Recent legislative changes in the wake of the novel coronavirus pandemic have placed an increased emphasis on the research activities of Local Public Health Institutes (PHIs) in Japanese municipalities. However, few studies have examined the ethical review processes of these institutes.

Methods: We analyzed information on (a) the status and year of establishment of "Ethics Review Committees" (and equivalent committees), (b) the number of review cases for each year, (c) the status of public disclosure of committee activities, and (d) the composition of committee members for 85 PHIs across Japan. Publicly available information from each PHI and the Ministry of Health, Labour and Welfare was used for the analysis.

Results: Out of 85 PHIs nationwide, about half of them publicly disclosed the establishment of their committees (41 committees, 48.2%). The number of review cases handled by the committees varied, with some committees having no cases or only one case. Among the committees, approximately 20% still maintained adherence to outdated national research ethics guidelines, and approximately 15% did not specify any guidelines they followed. Furthermore, we identified committees without external members (at least two committees) and those lacking public representation (four committees).

Conclusion: There are differences in the operational performance of ethics review committees at PHIs, possibly owing to varying levels of understanding of the guidelines, the degree of proactive engagement in academic research, and the emphasis on human subject research. There is a crucial need to accumulate and share experiences that support the review functions of the committees.