再论研究参与者知情同意伦理审查中的法律要点  

Further Discussion on Legal Points in Ethical Review of Research Participants’ Informed Consent

作　　者：刘炫麟 LIU Xuanlin(Research Center for Medical Security Law and Policy,China University of Political Science and Law,Beijing 100088,China)

机构地区：[1]中国政法大学医疗保障法律与政策研究中心,北京100088

出　　处：《中国医学伦理学》2023年第3期240-248,共9页Chinese Medical Ethics

基　　金：中国政法大学青年教师学术创新团队资助(21CXTD01)。

摘　　要：研究参与者权益保护主要通过知情同意制度和伦理委员会的伦理审查予以保障。实践中,有的申办者或者研究者在撰写知情同意书时,存在误用或者混用法律术语的情形。更为重要的是,在研究者执行知情同意的过程中,出现了告知不充分、不完整以及克减研究参与者具体权益的现象。这不仅影响到研究的科学性,而且有违临床试验或者医学研究的初衷,没有充分尊重研究参与者的人格尊严和生命价值,迫切需要伦理委员会在伦理审查时予以纠正,敦促研究者或者申办者及时修正和完善。The protection of research participants’ rights and interests is mainly guaranteed through the informed consent system and the ethical review of the Ethics Committee. In practice, some sponsors or researchers misused or mixed legal terms when writing the informed consent forms. More importantly, during the implementation of informed consent by researchers, the phenomenon that insufficient and incomplete notification, and derogation of research participants’ specific rights and interests occurred. This not only affected the scientific nature of the research, but also violated the original intention of clinical trials or medical researchers, and did not fully respect the human dignity and value of research participants. It was urgent for the ethics committee to correct it during the ethical review, and urge the researchers or sponsors to correct and improve it in a timely manner.

关 键 词：研究参与者 知情同意 伦理委员会 伦理审查 权益保护 

分 类 号：R-052[医药卫生]