Discussion of solutions to ethical issues in real-world study

• Published in: Frontiers of medicine Vol. 8; no. 3; pp. 316 - 320
• Main Authors: Wang, Sicheng, Liu, Baoyan, Xiong, Ningning, Xie, Qi, Zhang, Runshun, Zhou, Xuezhong, Qiao, Jie
• Format: Journal Article
• Language: English
• Published: Heidelberg Higher Education Press 01.09.2014; Springer Nature B.V
• Subjects: Biomedical Research - ethics; Biomedical Research - methods; Ethics; Humans; Medicine; Medicine & Public Health; Medicine, Chinese Traditional - methods; real-world study; Review; RWS; strategy; Traditional Chinese medicine; 世界范围; 伦理问题; 医药领域; 特征和; 现实世界; 科学性; 道德规范; real-world study; ethics; strategy
• ISSN: 2095-0217; 2095-0225; 2095-0225
• DOI: 10.1007/s11684-014-0354-y

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.