Evidence generated from real world data can be used to support drug development，therefoere the real world study of traditional Chinese medicine (TCM) has ushered in a good opportunity for development.However it faces new ethical risks and challenges.The article analyzes the common ethical issues involved in real world study, such as population selection, study duration, implementation scenarios, personnel, and research data.It outlines the choice and elements of informed consent models and further explores the challenges and solutions that TCM real world study may encounter in human experience, data governance, and research design.The analysis demonstrates that domestic regulations related to real world study are becoming more refined and aligned with international standards.Researchers need to dynamically learn relevant requirements, scientifically design clinical studies, and implement ethical requirements to ultimately form reliable, trustworthy, and usable real-world evidence.

real world study  /  ethical considerations  /  informed consent models  /  informed consent drafting