生物医学研究的知情同意过程及知情同意豁免

摘要

知情同意并不仅仅是知情同意书签字,它是一个持续的决定过程,发挥着保护受试者权益的重要作用.对知情同意过程中的关键问题,包括谁可以获得知情同意、谁可以同意或授权参加研究、信息告知过程、受试者信息理解、受试者自愿选择过程、知情同意书签字及免除签字的情况进行了系统地介绍.知情同意是保护受试者的权利和自主性的基本原则,但在特殊情况下是可以豁免的,包括不具备获取知情同意可行性及急救研究两种特殊情况.%Informed consent is not limited to obtain a signature on a consent form,but a constant,ongoing process.The author discussed the key questions of informed consent process,including who can obtain consent;who can provide consent;how to inform participants;participants' understanding of information;participants' autonomous decision making;signature and waivers of signature.Informed consent is a fundamental principle to protect participants' rights and autonomy,but in some circumstances,informed consent may be waived by the institutional review board,which special conditions were also discussed in this paper.