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Background <p>Research ethics committees (RECs) and institutional review boards provide independent ethical oversight of health-related research. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) increasingly conducts regulatory science (RS) research, which aims to generate scientific evidence to support regulatory decision-making. However, nationwide REC structures in Japan, and their alignment with the needs of RS oversight, have not been described.</p> Methods <p>We conducted a nationwide cross-sectional descriptive study using publicly available data from the Research Ethics Review Committee Reporting System of Japan (June 5, 2024). Committee size, gender composition, and members’ professional expertise were analyzed by institution type. We compared these findings with structural requirements in Japanese regulations and guidelines. In addition, we conducted a complementary literature-based analysis of PMDA-affiliated RS research using PubMed. Major Medical Subject Headings (MeSH) terms were examined to identify dominant research areas and to contextualize the REC structure within the current landscape of RS research.</p> Results <p>A total of 2,604 RECs comprising 26,786 members were identified nationwide. The mean committee size was 10.3. Overall, committees commonly included multiple lay members, with 68.0% of institutions having at least two public representatives. In contrast, a substantial gender imbalance was observed, with 70.1% of committee members being male across all institutional categories. Committee composition varied by institution type. Analysis of MeSH terms in PMDA-affiliated RS research publications showed frequent focus on regulatory review, pharmacovigilance, advanced biomedical technologies, and clinical trial methodology.</p> Conclusions <p>Japanese RECs were characterized by variation in committee size, occupational composition, and lay representation, while substantial gender imbalance persisted. Variations in committee composition reflected institutional differences in research characteristics. In the context of RS research, REC structures that incorporate relevant expertise alongside diverse perspectives may help inform discussions on ethical review practices.</p>

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Structural characteristics of research ethics committees in Japan and their relevance to regulatory science: a nationwide descriptive study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月7日

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  • Tomohiko Hara,
  • Yuki Iwahara,
  • Shunsaku Murakawa

摘要

Background

Research ethics committees (RECs) and institutional review boards provide independent ethical oversight of health-related research. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) increasingly conducts regulatory science (RS) research, which aims to generate scientific evidence to support regulatory decision-making. However, nationwide REC structures in Japan, and their alignment with the needs of RS oversight, have not been described.

Methods

We conducted a nationwide cross-sectional descriptive study using publicly available data from the Research Ethics Review Committee Reporting System of Japan (June 5, 2024). Committee size, gender composition, and members’ professional expertise were analyzed by institution type. We compared these findings with structural requirements in Japanese regulations and guidelines. In addition, we conducted a complementary literature-based analysis of PMDA-affiliated RS research using PubMed. Major Medical Subject Headings (MeSH) terms were examined to identify dominant research areas and to contextualize the REC structure within the current landscape of RS research.

Results

A total of 2,604 RECs comprising 26,786 members were identified nationwide. The mean committee size was 10.3. Overall, committees commonly included multiple lay members, with 68.0% of institutions having at least two public representatives. In contrast, a substantial gender imbalance was observed, with 70.1% of committee members being male across all institutional categories. Committee composition varied by institution type. Analysis of MeSH terms in PMDA-affiliated RS research publications showed frequent focus on regulatory review, pharmacovigilance, advanced biomedical technologies, and clinical trial methodology.

Conclusions

Japanese RECs were characterized by variation in committee size, occupational composition, and lay representation, while substantial gender imbalance persisted. Variations in committee composition reflected institutional differences in research characteristics. In the context of RS research, REC structures that incorporate relevant expertise alongside diverse perspectives may help inform discussions on ethical review practices.