医学学术期刊对临床研究文稿的伦理审查要求与思考--基于医院伦理委员会视角  

Requirements and Thoughts on Ethical Review of Clinical Research Manuscripts in Medical Academic Journals:from the Perspective of Ethics Committee

作　　者：张卓然[1] 李小莹[1] 李晓玲[1] 王香平[1] 岳小林 ZHANG Zhuoran;LI Xiaoying;LI Xiaoling;WANG Xiangping;YUE Xiaolin(Xuanwu Hospital Capital Medical University,Beijing 100053,China)

机构地区：[1]首都医科大学宣武医院,北京100053

出　　处：《中国医学伦理学》2022年第11期1202-1208,共7页Chinese Medical Ethics

基　　金：北京市医学伦理管理和审查质量提高项目“北京市医学伦理审查互认现状调研”(京伦2021-2);首都卫生管理与政策研究基地开放性课题重点项目“北京地区三级医院伦理审查委员会审查能力规范化建设的研究”(2013JD02)。

摘　　要：医学学术期刊对投稿论文或报告具有特定的伦理要求和审查原则。研究者常在(拟)投稿阶段向伦理委员会咨询期刊伦理要求的合理性,或是请求协助解决期刊伦理审查要求为投稿论文或发布研究报告所属的临床研究申请伦理审查。基于医院伦理委员会视角,探讨学术期刊对临床研究论文或报告的伦理审查要求,结合对临床研究作者诉求处理实践、申请伦理审查现状、常见问题和案例,提出三项建议:学术期刊应对投稿论文或报告文稿的伦理审查要求具体化;研究者应将“伦理先行”内化于心、依法依规进行研究实化于行;伦理委员会应发挥正向引导和服务,协同临床研究管理部门做好研究监管,为进一步规范临床研究论文及报告发布提供思路。There are specific ethical requirements and review principles for submitting papers or reports in medical academic journals.Researchers often consult the ethics committee on the rationality of the ethical requirements of journals at the(to be)submission stage,or ask for assistance in solving the ethical review requirements of journals:applying for ethical review for the clinical research to which submitted papers or research reports.Based on the perspective of hospital ethics committee,this paper discussed the ethical review requirements of academic journals for clinical research papers or reports.Combined with the practice of handling clinical research authors demands,the current situation of applying for ethical review,common problems and cases,this paper put forward three suggestions:academic journals should concretize the ethical review requirements of submitted papers or reports;researchers should internalize ethics first in their hearts,and conduct research according to laws and regulations;ethics committee should give full play to positive guidance and services,and cooperate with clinical research management departments to strengthen and complete the supervision of clinical research.So as to provide ideas for further standardizing the publication of clinical research papers and reports.

关 键 词：医学学术期刊 临床研究论文 伦理审查 伦理委员会 

分 类 号：G237.5[文化科学]