口腔医学真实世界研究的伦理考量  

Ethical Considerations of Real World Study in Stomatology

作　　者：许锋[1,2] 甄红[1,2] 刘墨池 罗蒙 XU Feng;ZHEN Hong;LIU Mo-chi(Discipline Planning Department/Ethics Committee,Shanghai Ninth People's Hospital,Shanghai JiaoTong University School of Medicine,Shanghai 200011,China)

机构地区：[1]上海交通大学医学院附属第九人民医院学科规划处/伦理委员会,上海200011 [2]上海交通大学中国医院发展研究院学科建设研究所,上海200025

出　　处：《医学与哲学》2021年第21期15-18,共4页Medicine and Philosophy

基　　金：2021年上海市卫生健康委员会卫生健康政策研究课题(2021HP54)。

摘　　要：随着民众对口腔健康的重视,口腔医学的临床研究亟需被关注。口腔医学的真实世界研究能较好地补充口腔医学新药/器械临床试验的缺口,但在开展过程中却面临知情同意如何获取、口腔数据如何质控及如何使用等相关问题。结合所在医院的伦理经验对口腔真实世界研究的监管提出了建议,包括研究医生涉及利益冲突的伦理监管、研究过程中知情同意的获取、口腔真实世界的数据共享的伦理要求,以促进口腔医学研究的有序、高质量的发展。With the public's attention to oral health,the clinical research of stomatology needs to be paid more attention.The real world study of stomatology can better supplement the gap of clinical trials of new drugs/devices,but it faces problems such as how to obtain informed consent,how to carry out quality control of oral data,how to use oral data,etc.Combined with the ethical experience of the hospital,the authors put forward some suggestions on the supervision of oral real world study,including the ethical supervision of the conflicts of interest,the acquisition of informed consent in the research process,the ethical requirements of oral real world data sharing,so as to promote the well-regulated and high-quality development of stomatology.

关 键 词：口腔医学 真实世界研究 医学伦理 临床研究 

分 类 号：R-05[医药卫生]