真实世界研究的伦理审查问题与对策研究

Research on the Problems and Countermeasures of Ethical Review in Real-world Research

真实世界研究是近年全球范围内临床研究的前沿。从国内外真实世界研究的现状出发,探讨存在知情同意、数据质量、数据管理和隐私保护、利益冲突管理、安全性、风险与受益等伦理问题。结合近年实践经验和基本伦理准则,提出了伦理审查要点,如探索新的数据采集模式和标准、方案设计科学合理、落实知情同意、保护受试者隐私、利益冲突管理、良好的风险受益比、公平选择受试者等,以提高真实世界研究的科学性和伦理性。

Real-world research is the forefront of clinical research worldwide in recent years.Starting from the current situation of real-world research at home and abroad,this paper discussed the ethical issues such as informed consent,data quality,data management and privacy protection,conflict of interest,security,risk and benefit.Combined with the practice experience in recent years and the basic ethical standards,this paper put forward the key points of ethical review,such as exploring new data collection modes and standards,scientific and reasonable scheme design,implementing informed consent,protecting the privacy of subjects,conflict of interest management,good risk benefit ratio,fair selection of subjects,etc.,so as to improve the scientificity and ethics of real-world research.