北京大学深圳医院伦理委员会实行二级管理架构，下设六个专业分支伦理委员会，包括一级伦理委员会和二级科研伦理审查委员会、临床试验伦理审查委员会、生物医学新技术伦理审查委员会、临床伦理咨询委员会、生殖医学伦理委员会、产前诊断伦理委员会。各分支伦理委员会秉持独立、专业、高效的原则，承担以下核心工作： 1. 伦理审查工作：负责开展全面的伦理审查，涵盖初始审查、跟踪审查，有权根据审查结果作出批准、不批准、终止或暂停项目的决定。 2. 临床伦理咨询服务：针对临床实践中遇到的复杂伦理问题（如患者自主权与家庭决策冲突、稀缺医疗资源分配、新技术应用的伦理风险等），提供专业、及时的伦理咨询。 其组织与运作严格遵循《生物医学新技术临床研究和临床转化应用管理条例》《人工智能科技伦理审查与服务办法（试行）》《药物临床试验质量管理规范（2026年修订）》《医疗器械临床试验质量管理规范》《涉及人的生物医学研究伦理审查办法》《涉及人的生命科学和医学研究伦理审查办法》《科技伦理审查办法（试行）》《世界医学大会赫尔辛基宣言》《涉及人的健康相关研究国际伦理指南》等法律法规和指南。 委员会已依法获得执业登记机关的备案许可，并持续接受卫生行政管理部门与药监行政管理部门的指导与监督。 The Institutional Review Board (IRB) of Peking University Shenzhen Hospital adopts a two-tier management structure, , with three Institutional Review Boards (IRBs) and three Clinical Ethics Committees (CECs), namely the Scientific Research Ethics Review Committee (IRB), the Clinical Trial Ethics Review Committee (IRB), the Biomedical New Technology Ethics Review Committee (IRB), the Clinical Ethics Consultation Committee (CEC), the Reproductive Medicine Ethics Committee (CEC), and the Prenatal Diagnosis Ethics Committee (CEC). Adhering to the principles of independence, professionalism and efficiency, each sub-IRB undertakes the following core responsibilities: 1. Ethical Review: Conducts comprehensive ethical reviews including initial review and continuing review, and is authorized to approve, disapprove, terminate or suspend research projects based on review outcomes. 2. Clinical Ethics Consultation Service: Provides timely and professional ethical consultation for complex ethical issues arising in clinical practice, such as conflicts between patient autonomy and family-based decision-making, allocation of scarce medical resources, and ethical risks associated with the application of new medical technologies. The organization and operation of the IRB strictly comply with laws, regulations and guidelines, including the Regulations on the Clinical Research and Translational Application of Biomedical New Technologies, the Measures for the Ethical Review and Services of Artificial Intelligence Technology (Trial), Good Clinical Practice for Pharmaceutical Trials (2026 Revision), Good Clinical Practice for Medical Device Clinical Trials, the Measures for the Ethical Review of Biomedical Research Involving Human Subjects, the Measures for the Ethical Review of Life Science and Medical Research Involving Human Subjects, the Measures for Science and Technology Ethics Review (Trial), the Declaration of Helsinki issued by the World Medical Association, and the International Ethical Guidelines for Health-related Research Involving Humans. The IRB has obtained official filing approval from the medical licensing authority, and receives ongoing guidance and supervision from health administrative authorities and drug regulatory authorities.