2017-2020年《中华地方病学杂志》中的医学伦理审查结果分析

Analysis of medical ethics review results in the Chinese Journal of Epidemiology from 2017 to 2020

目的了解医学伦理审查在地方病科研与防治领域的应用情况。方法采用资料回顾性分析,收集2017-2020年《中华地方病学杂志》公开发表的论著、现场调查和临床医学等栏目文章,分析各栏目及国家级、省级、市级基金项目和非基金项目中的医学伦理审查情况。统计学分析采用趋势χ^(2)检验和Cochran-Mantel-Haenszel(CMH)检验。结果共收集2017-2020年发表文章638篇,剔除36篇,剩余602篇。①4年间经过医学伦理审查产出的论文所占比例分别为56.85%(83/146)、62.50%(105/168)、59.87%(94/157)、60.31%(79/131),趋势检验差异无统计学意义(Z=0.41,P>0.05);论著、现场调查、临床医学栏目产出的论文所占比例不同年度间比较差异无统计学意义(χ^(2)=0.01、1.31、1.92,均P>0.05)。②4年间经过医学伦理审查的各类基金项目产出的论文所占比例分别为60.55%(66/109)、62.28%(71/114)、62.38%(63/101)、60.22%(56/93),趋势检验差异无统计学意义(Z=-0.03,P>0.05);国家级项目、省部级项目、市级项目产出的论文所占比例不同年度间比较差异无统计学意义(χ^(2)=0.06、0.02、0.19,均P>0.05)。③4年间获上级伦理委员会批准并标有批准号的科研项目产出论文所占比例,趋势检验差异有统计学意义(Z=2.85,P<0.01);不同年度间比较差异有统计学意义(χ^(2)=8.13,P<0.01);论文所占比例从2017年的8.22%(12/146)上升到2020年的18.08%(25/131),差异有统计学意义(χ^(2)=7.04,P=0.008)。④4年间在知情同意基础上经本人同意发表的论文所占比例,趋势检验差异无统计学意义(Z=-0.53,P>0.05);不同年度间比较差异无统计学意义(χ^(2)=0.28,P>0.05)。结论医学伦理审查得到了广大科研工作者的重视,在地方病学科研和防治领域得到了广泛应用。

Objective To learn about the application of medical ethics review in scientific research and prevention of endemic diseases.Methods The method of retrospective analysis was used,original articles on field epidemiological investigation and clinical medicines published by Chinese Journal of Epidemiology from 2017 to 2020 were collected.Examination of medical ethics in national,provincial and municipal fund programs and nonfund projects was carried out.Statistical analysis was performed using Cochran-Armitage trend test and Cochran-Mantel-Haenszel(CMH)test.Results A total of 638 articles were collected from 2017-2020,with 36 excluded and 602 remaining.The proportion of papers published after medical ethics review over the past four years was 56.85%(83/146),62.50%(105/168),59.87%(94/157),and 60.31%(79/131),respectively.There was no statistically significant difference in trend testing(Z=0.41,P>0.05).There was no statistically significant difference in the proportion of papers produced by academic works,on-site investigations,and clinical medicine programs among different years(χ^(2)=0.01,1.31,1.92,P>0.05).The proportion of papers published that supported by various fund programs that had undergone medical ethics review over the past four years was 60.55%(66/109),62.28%(71/114),62.38%(63/101),and 60.22%(56/93),respectively.The trend test showed no statistically significant difference(Z=-0.03,P>0.05).There was no statistically significant difference in the proportion of papers published that supported by national level projects,provincial and ministerial level projects,and municipal level projects among different years(χ^(2)=0.06,0.02,0.19,P>0.05).The difference in the trend test of the output papers of research projects approved by the higher-level ethics committee and marked with approval numbers over the past 4 years was statistically significant(Z=2.85,P<0.01);the difference was statistically significant when compared across years(χ^(2)=8.13,P<0.01);the proportion of papers increased from 8.22%(12/146)in 2017 to 18.08%(25/131)in 2020(χ^(2)=7.04,P=0.008).There was no statistically significant difference(Z=-0.53,P>0.05)in the proportion of papers that expressed their consent in terms of informed consent over the past 4 years;There was no statistically significant difference in comparison between different years(χ^(2)=0.28,P>0.05).Conclusions Medical ethics review has been taken seriously by the majority of researchers and is widely used in endemic scientific research and prevention projects.