2014, Volume 8, Issue 3
Frontiers of Medicine >> 2014, Volume 8, Issue 3 doi: 10.1007/s11684-014-0354-y
Discussion of solutions to ethical issues in real-world study
1. Department of Science and Technology, State Administration of Traditional Chinese Medicine of the People’s 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’anmen 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’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
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Abstract
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.
Keywords
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