研究者发起的临床研究中常见伦理问题及监管考量

Common Ethical Issues in Investigator-initiated Clinical Studies and Regulatory Considerations

临床研究是医学研究领域最重要的部分,是医学创新走向临床实践的必经之路,日益受到国际医学界的重视。然而,我国研究者发起的临床研究也存在一些问题,主要表现在:缺少科学、详实、可依的研究方案,伦理批件及知情同意签署不规范,缺乏质量管理体系或质控措施,高风险或多中心研究缺乏独立数据监查委员会等。为了加强对研究者发起临床研究的受试者保护和质量管理,建议医疗卫生机构尽快建立适宜的临床研究管理体系和受试者保护工作体系,发展适用于研究者发起的临床研究的稽查和监查专业队伍,开展基于风险的管理,加强研究者培训。

As the most important part of medical research,clinical research is irreplaceable in medical innovation and development.However,common issues still exist in the investigator-initiated clinical studies in China,including unscientific,incomplete,unreliable research protocols,improper informed consent or ethical approval,imperfect quality management system or quality control measures,absence of independent data and safety monitoring committee in high risk and multi-center trials,etc.To improve the situation,the authors suggest that medical and health institutions should establish suitable clinical research management system and protection system of human subjects as soon as possible,develop human resources for inspection and supervision of investigator-initiated clinical studies,carry out risk-based management and strengthen the training of researchers.