Current Status and Issues of Ethical Review for Surgical Research in Japanese University Hospitals.

Introduction: In clinical research, ethical review is required prior to conducting the research. A surgical procedure is a complex intervention with properties that make it more difficult to evaluate rigorously and monitor than drug treatments. This study aimed to clarify the current status and issues in the ethical review and monitoring of surgical research.

Methods: We developed a self-administered questionnaire on surgical ethical review. The questionnaire was distributed to university hospitals in Japan and collected from November 2018 to February 2019. The distributed questionnaire consisted of the reviewed items, items with difficulties, and important items on ethical review. Fisher's exact test or the chi-square test was used for analysis.

Results: The questionnaires from 39 medical university hospitals were completed with appropriate answers to all items. "Technical review" was conducted at a significantly lower proportion (n = 30/39, 76.9%, p = 0.002). "Evaluation of the progress and results" was also (n = 22/39, 56.4%, p < 0.001). University hospitals in which "technical aspects and ethical review" was regarded the most important and difficult were higher (n = 24/39, 61.5%; n = 26/39, 66.7%, respectively). Respondents considered not only items written in the study protocol but also those on monitoring or oversight of surgical research as difficult.

Conclusions: Our findings suggest that it is necessary to improve the ethical review system and provide supports to conduct an appropriate review for surgical research, e.g., technical aspect review or study progress/result evaluation.