研究者发起的医学科研项目知情同意相关问题及建议——以某三甲医院为例

Problems and suggestions on informed consent of medical research projects initiated by researchers--A case study of a class a tertiary hospital

知情同意原则是涉及人的生物医学研究伦理原则之首,是保护受试者权益的重要手,是医学科研伦理审查的重要内容。从另一角度来看,正确的知情同意同样也保护研究者的合法权益。本文以某三甲医院最近的伦理审查情况和实地访查结果为研究对象,分析总结了研究者发起的医学科研项目知情同意相关问题,并提出了相应的建议。

The principle of informed consent is the first ethical principle of biomedical research involving human beings.It is an important means to protect the rights and interests of subjects and an important content of ethical review of medical research.From another perspective,proper informed consent also protects the legitimate rights and interests of researchers.Based on the recent ethical review and on-the-spot investigation results of a Class A Tertiary hospital,this paper analyzes and summarizes the problems related to informed consent of medical research projects initiated by researchers,and puts forward corresponding suggestions.