【摘要】 近年来,真实世界研究日益得到重视。因其涉及患者资料,研究结果可能会对患者目前及未来权益与安全产生影响,故医学伦理审查也需应用于真实世界临床研究,同时应思考研究结论对患者产生结局影响的伦理性。本文描述了医学伦理学的来源及如何应用于传统临床试验;简要介绍了真实世界研究的相关特性;探讨了如何对真实世界研究进行医学伦理学审查,以期促进真实世界研究的伦理学审查机制的完善,更好保护患者的权益与安全。更多还原

【Abstract】 Recently,real world studies(RWS)have received increasing attentions.Such studies typically involve patient information,and their results may have potentially significant impact on patient well-being and safety.When reviewing the protocol of real world studies,ethical issues should be carefully considered and assessed.This paper discussed three issues,including the overview of bioethics and its application to classic clinical trials,key features of RWS,and medical ethical considerations on RWS.更多还原