临床研究中伦理学若干问题思考

Thinking on Several Ethical Problems in the Clinical Research

本研究建立在浙江中医药大学附属第一医院接受国家中医药管理局"中医药临床研究伦理审查平台建设与评估"基础上。临床研究伦理审查平台是一个完整的体系——"受试者保护体系",包括医疗卫生组织机构、伦理委员会、伦理委员会办公室、研究科室与研究人员4大方面。其中,研究科室与研究人员平台建设尤为关键,所有与受试者保护体系密切相关的治疗、保护、风险控制、不良事件监督都是通过研究者完成的。但在评估过程中不难发现临床研究者伦理意识相对薄弱,对伦理审查流程不熟悉,没有把受试者保护和临床研究摆在同样的高度。这类问题同样在国内其他医疗机构的伦理审查评估中凸显出来,成为当前建立受试者保护体系的短板。为此,本研究参考《中医药临床研究伦理审查平台评估标准》评估要点,从伦理委员会角度出发,提出临床研究者在受试者保护和方案设计与实施方面需注意的伦理学问题,并针对研究者临床研究伦理现状提出改进建议,进而促使临床研究者提高伦理意识,熟悉伦理审查流程,更好地完成保护受试者的中心任务。

This study was conducted in the First Affiliated Hospital of Zhejiang Chinese Medical University for the project of ＂Establishment and Assessment of Ethics Review Platform for TCM Clinical Research.＂ The Ethics Review Platform for Clinical Research is a complete system,which is a ＂Participant Protection System.＂ It includes four aspects,which are the medical and health institution,ethics committee,ethics committee office,research departments and researchers.In this system,the establishment of research departments and researchers platform is the most crucial part.All treatment,protection,risk control,adverse event supervision,which are closely related to the ＂Participant Protection System＂ are completed by researchers.However,during the assessment process,a series of problems were found,such as the current weak ethical consciousness of researchers,less familiar with ethical review process and do not pay equal attention to the participant protection as clinical research.This kind of problem was also found in other hospital assessments in China,which has become a short board of the ＂Participant Protection System.＂ Therefore,from the aspect of the ethics committee,this article presented several ethics problems which should be paid more attention to by researchers such as participant protection,plan design and conduction during the clinical research and also gave some useful advices to change the situation,according to the ＂Assessment Standard of Ethics Review Platform for TCM Clinical Research.＂ In this way,researchers will develop their ethical consciousness and be more familiar with the ethics review process in order to complete key task of participant protection.