Discussion of solutions to ethical issues in real-world study

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• 作者：Sicheng Wang (1)
  Baoyan Liu (2)
  Ningning Xiong (3)
  Qi Xie (4)
  Runshun Zhang (5)
  Xuezhong Zhou (6)
  Jie Qiao (7)
  
• 关键词：real ; world study ; ethics ; strategy
• 刊名：Frontiers of Medicine
• 出版年：2014
• 出版时间：September 2014
• 年：2014
• 卷：8
• 期：3
• 页码：316-320
• 全文大小：102 KB
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• 作者单位：Sicheng Wang (1)
  Baoyan Liu (2)
  Ningning Xiong (3)
  Qi Xie (4)
  Runshun Zhang (5)
  Xuezhong Zhou (6)
  Jie Qiao (7)
  
  1. Department of Science and Technology, State Administration of Traditional Chinese Medicine of the People鈥檚 Republic of China, Beijing, 100027, China
  2. China Academy of Chinese Medical Sciences, Beijing, 100700, China
  3. GCP Center, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, 210029, China
  4. Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China
  5. Department of Gastroenterology, Guang鈥檃nmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China
  6. School of Computer and Information Technology, Beijing Jiaotong University, Beijing, 100044, China
  7. Office of Ethic Committee, Guang鈥檃nmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China
  
• ISSN：2095-0225

文摘

In recent years, the paradigm of real-world study (RWS) has been at the forefront of clinical research worldwide, particularly in the field of traditional Chinese medicine. In this paper, basic features and nature of real-world clinical studies are discussed, and ethical issues in different stages of RWS are raised and reviewed. Moreover, some preliminary solutions to these issues, such as protecting subjects during the process of RWS and performing ethical review, are presented based on recent practices and basic ethical rules to improve the scientific validity and ethical level of RWS.