药物临床试验伦理委员会职责和法律地位探析

Responsibilities and legal status of drug clinical trial institutional ethics committee(IEC)

随着我国药物临床试验伦理委员会的逐步发展,出现了诸如其审查结果是否公正、对于审查结果有异议时应如何申诉,向谁申诉,包括隶属关系的混乱等问题。而这些问题的出现均是由相关法律法规对其模糊的定位等因素造成。本文对其法律地位和审查行为的法律性质进行了探讨,认为在现行的法律法规之下,伦理委员会在未尽审查义务造成受试者损害时,也应当承担道德和信誉的责任;伦理委员会不具有独立承担民事责任的能力,按照民事委托责任原则,应由发起一项药物临床研究的申办者,以及研究者承担相应责任。

With the gradually development of the institutional ethics committee(IEC) of drug clinical trials in China, some problems appear such as whether the censor results are fair or not? How to appeal for censor results if you have any objections, and appeal to whom? And confusion about the subordination relationship issues and etc. The emergences of these problems are caused by factors such as the fuzzy positioning. in relevant laws and regulations. In this paper, the legal characteristic of legal status and censor nature are discussed. Under the current laws and regulations, IEC should bear the responsibility of the moral and credit when some damage is done to subjects if IEC does not complete the censor obligation. Because IEC does not have the ability to independently bear civil liability, in accordance with the principle of civil entrusted responsibility, the sponsor of drug clinical research and the researchers should take the corresponding responsibility.