In recent years, China has successively issued a series of regulations covering the clinical translation of biomedical new technologies, science and technology ethics, investigatorinitiated clinical research, special clinical research on traditional Chinese medicine, and ethical review for humanparticipated life science and medical research. Combined with the 2024 Declaration of Helsinki, an international ethical guideline, a multilevel, domainspecific and crossdepartmental ethical governance system for medical research has been established. Nevertheless, institutional review boards (IRBs) of medical institutions and research administrators are still confronted with governance challenges including ambiguous legal boundaries of regulations, redundant multiple reviews, the absence of review mechanisms tailored to the characteristics of traditional Chinese medicine, gaps in ethical supervision for the translation of new technologies, and poor alignment between domestic and international ethical standards. This paper sorts out five core domestic ethical regulations together with the 2024 Declaration of Helsinki, forming six documents in total. It horizontally compares their legal validity, scope of application, institutional strengths and limitations, clarifies the applicable scenarios for different types of clinical research, analyzes the practical dilemmas arising from the parallel implementation of multiple regulations, and proposes a practical hierarchical and collaborative ethical review system featuring “general provisions as the baseline, domainspecific supplementary rules, overall coordination for major scientific research, and alignment with elevated international standards”.