[Ethical considerations for investigator-initiated vaccine clinical trials in China]

Investigator-initiated vaccine clinical trials are an important branch of Investigator-Initiated Trials (IIT), focusing on scientific issues such as vaccine protective efficacy, rare adverse reactions, optimization of vaccination strategies, and exploration of immune mechanisms. By systematically sorting out the development of ethical requirements related to IIT in China, this paper compares in depth the common requirements of investigator-initiated vaccine clinical trials and registered vaccine clinical trials in terms of informed consent and ethical review, and specifically analyzes the special ethical considerations regarding conflicts of interest and research on special populations. At the same time, it discusses the ethical issues and challenges faced by emergency ethical review and informed consent in the conduct of investigator-initiated vaccine clinical research in the context of public health emergencies, aiming to promote its standardized development under the dual framework of social value and scientific value.