A Proposed Model of Core Competencies for Research Ethics Consultants

Kenji Matsui,Hiroaki Yanagawa,Yusuke Inoue,Tadao Takano

doi:10.1007/s41649-021-00178-y

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.

Highlights

Research ethics consultation services (RECS) involve consultations with researchers to provide advice and recommendations that address ethical issues related to the content of studies throughout the research period, from the clinical research protocol drafting/proposal stage before ethics review to the period after
This paper investigated the core competencies required of research ethics consultants responsible for RECS, which have proliferated in recent years, by taking as reference the existing core competencies model for clinical ethics consultants, which has already been extensively studied
Our proposed model has been developed based on solely the situation and our experiences of RECS in Japan, the core competencies which the model gives would, we consider, be applicable to other places

Summary

Introduction

When considering the core competencies required of research ethics consultants who lead RECS, it is first necessary to consider some basic questions: What is the general flow by which RECS advice is formulated and implemented? It is important, when examining the core competencies of research ethics consultants, to consider the above differences between HCECS and RECS.

Results

Conclusion