研究者发起的临床研究项目伦理审查现实矛盾与对策思考

通过对我国研究者发起的临床研究项目伦理审查现状进行分析,从研究者发起的临床研究项目伦理审查执行力不强、监管不到位,临床研究设计伦理观念不足以及研究者伦理意识薄弱三个方面入手进行问题剖析。结合相关法规与工作实践,提出了强化卫生行政部门监管职能,加强研究者发起的临床研究项目主管部门监管,包括加强医疗机构伦理监管体系建设、完善伦理委员会标准操作规程、加强研究者伦理培训以及加强伦理宣传普及四个方面对策,以期提高研究者发起的临床研究项目伦理审查质量,促进其更加科学规范开展。

Current Contradiction and Countermeasures on the Ethical Review of Investigator-initiated Trial

Through the analysis of current situation of the ethical review of investigator-initiated trial subjects in China,this paper analyzed the problems from the following three aspects:inadequate enforcement and imperfect supervision of ethical review,insufficient ethical idea in clinical research design and weak ethical awareness of investigators.Based on relevant regulations and practice,the authors put forward four countermeasures to strengthen the supervision from health and family planning administrative departments,and establish trial competent department.Some suggestions were provided,including enhancing the construction of the ethical supervision system,improving standard working procedures in ethics committee,enhancing ethical training,and reinforcing the publicity and popularization of ethics,so as to improve the quality of ethical review of investigator-initiated trial subjects and develop it in a more scientific and standardized way.