A Proposed Model of Core Competencies for Research Ethics Consultants

Kenji Matsui; Yusuke Inoue; Hiroaki Yanagawa; Tadao Takano

doi:10.1007/s41649-021-00178-y

A Proposed Model of Core Competencies for Research Ethics Consultants

Asian Bioeth Rev. 2021 May 29;13(3):355-370. doi: 10.1007/s41649-021-00178-y. eCollection 2021 Sep.

Authors

Kenji Matsui¹, Yusuke Inoue², Hiroaki Yanagawa³, Tadao Takano⁴

Affiliations

¹ Division of Bioethics and Healthcare Law, National Cancer Center Japan, Tokyo, Japan.
² Department of Public Policy, the Institute of Medical Science, the University of Tokyo, Tokyo, Japan.
³ University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics, Tokushima, Japan.
⁴ Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.

Abstract

Research ethics consultation services (RECS), which function as an advisory service to facilitate the resolution of complex ethical issues in clinical research, have been proliferating over the last decade. However, the qualification of an individual who provides RECS, or "a research ethics consultant," has not been thoroughly investigated, in contrast to healthcare ethics consultants, whose core competencies have been discussed and clarified to a great extent. In this study, we investigated core competencies necessary for research ethics consultants, referring to the core competency models of ethics consultants developed in the healthcare practice context, and propose a competency model for research ethics consultants.

Keywords: Clinical research; Core competencies; Japan; Model; Research ethics; Research ethics consultation.