[Clinical research and medical ethics in the era of artificial intelligence]

Artificial intelligence (AI), a core technology of the Fourth Industrial Revolution, profoundly reshapes the landscape of modern medicine. AI can extract information from extensive datasets, optimizing trial design, and enhancing research efficiency. It is widely applied in field such as medical imaging, clinical decision support, precision medicine, and drug development. Notably, AI brings revolutionary opportunities to clinical research and practice; however, it also raises a series of serious ethical and regulatory challenges regarding data privacy, algorithmic bias, attribution of responsibility, and informed consent. This article systematically discusses the current applications of AI at various stages of clinical research, deeply analyzes the core ethical dilemmas arising from these applications, and outlines corresponding ethical governance frameworks and response strategies. In addition, we advocated establishment of a collaborative governance system that is people-oriented and technology-driven, emphasizing strict adherence to ethical principles throughout the entire process of technological development to ensure the scientific, fair, and safe nature of clinical research, ultimately resulting in the coordinated progress of artificial intelligence technology and medical ethics.