基于研究者伦理抉择能力构建临床研究伦理培训体系  

Constructing the Ethics Training System of Clinical Research Based on the Ethics Decision Ability of Researchers

作　　者：陈少莹 蒋辉 CHEN Shaoying;JIANG Hui(Office of Ethics,Ningbo First Hospital of Zhejiang Province,Ningbo 315010,China;Ethics Committee,Zhangzhou Affiliated Hospital of FuJian Medical University,Zhangzhou 363000,China)

机构地区：[1]宁波市第一医院伦理办公室,浙江宁波315010 [2]福建医科大学附属漳州市医院伦理委员会,福建漳州363000

出　　处：《中国医学伦理学》2023年第3期249-254,共6页Chinese Medical Ethics

基　　金：宁波市科技计划项目“提升宁波医院临床试验能力对策研究——宁波医院‘互联网+情境式培训’提升多元临床试验能力的服务体系构建”(2022R029)。

摘　　要：加强临床研究人员能力建设是实现高质量临床研究的重要途径,伦理培训是其中重要组成部分。但法律法规对伦理培训要求未具体细化,不少研究者对伦理认识停留在形式上“通过伦理审查”,而伦理培训内容也常缺失伦理原则、伦理学考虑与抉择等内容。鉴于此,提出基于研究者伦理抉择能力构建临床研究伦理培训体系,从全程伦理审查的各环节设计实施伦理学概念、伦理原则把握与伦理抉择实践等,将其有机融合到临床研究机构的培训体系中,促成注重受试者健康权益为先的生命伦理意识等自觉渗透内化为研究者行为,积累为研究者伦理抉择能力。Strengthening the capacity building of clinical researchers is an important way to achieve high-quality clinical research, ethics training is an important part of it. However, laws and regulations do not specify the requirements for ethical training, many researchers’ cognition of ethics often remain in the form of “passing ethical review”, and the content of ethical training often lacks ethical principles, ethical considerations and choices, etc. In view of this, this paper proposed to build a clinical research ethics training system based on the researchers’ ethical decision ability, design and implement ethical concepts, ethical principles grasp, and ethical decision practices from each link of the whole process ethical review, organically integrate them into the training system of clinical research institutions, and promote the conscious infiltration of bioethical awareness that focused on the subjects’ health rights and interests to internalize into the behavior of researchers, accumulate to the ethical decision ability of researchers.

关 键 词：研究者 伦理抉择能力 伦理管理 临床研究 伦理培训体系 

分 类 号：R-052[医药卫生]