护理人员科研伦理实施过程中存在的问题及对策研究
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摘要
[目的]分析目前护理人员科研伦理实施状况及存在的问题,提出相应的对策,为加强临床护理科研伦理审查机制建设提供现实的依据,以维护护理科学研究中受试者的权益。[方法]于2016年11月—2017年1月采用自行编制的护理人员科研伦理认知及执行现状问卷对全国7个分区共14所三级甲等医院的护理人员进行调查,并利用文献计量法对2016年—2018年《中华护理杂志》《护理研究》《中国实用护理杂志》《护理学杂志》《护士进修杂志》所刊载的研究类论文伦理委员会批准及知情同意等相关项目的描述进行统计。[结果]护理人员科研伦理认知总分为(70.93±3.04)分,伦理执行总分为(11.62±2.94)分。不同态度、培训经历、职称、科室护理人员科研伦理认知情况不同,不同培训经历、学历、职称、态度护理人员科研伦理执行情况不同(P<0.05)。研究类论文中有伦理委员会审查和知情同意表述的论文比例均较低。[结论]护理人员科研伦理认知和执行状况不容乐观,相关管理人员应高度重视,努力提高护理人员对科研伦理重要性的认识,加大对护理人员科研伦理知识的培训力度,严格落实护理科研伦理审查制度,专业期刊应重视论文中有关科研伦理的说明。
Objective:To analyze the current implementation status and existing problems of nursing staff′s research ethics,and put forward corresponding countermeasures,so as to provide a realistic basis for strengthening the construction of review mechanism on clinical nursing research ethics to safequard the rights and interests of subjects in nursing scientific research.Methods:From November 2016 to January 2017,a self-developed questionnaire on the ethical cognition and implementation status of nursing staff was conducted to investigate the nursing staff in 14 third grade hospitals in 7 sub-districts nationwide.The bibliometric method was used for statistics of published research papers′ ethics committee approval and informed consent and other related items published in "Chinese Journal of Nursing", "Nursing Research", "Chinese Practical Nursing Journal", "Nursing Journal", "Nursing Training Magazine" from 2016-2018.Results:The ethical cognition total score of nursing staff was(70.93±3.04),and the ethical execution total score was(11.62±2.94).Nursing staff with different attitudes,training experiences,professional titles and departments had different ethics cognitive levels,and nursing staff with different training experiences,education,profession titles and attitude had different ethics implementation(P<0.05).The proportions of papers with ethics committee review and informed consent in the research papers was lower.Conclusions:Nursing staff′s ethical cognition and implementation status are not optimistic.Relevant management personnel should attach great importance to it,strive to improve the awareness of nursing staff on the importance of scientific research ethics,increase the training of nursing staff′s scientific ethics knowledge,and strictly implement inspection system of nursing research.In the ethical review system,professional journals should pay attention to the description of scientific ethics in the paper.
Objective:To analyze the current implementation status and existing problems of nursing staff′s research ethics,and put forward corresponding countermeasures,so as to provide a realistic basis for strengthening the construction of review mechanism on clinical nursing research ethics to safequard the rights and interests of subjects in nursing scientific research.Methods:From November 2016 to January 2017,a self-developed questionnaire on the ethical cognition and implementation status of nursing staff was conducted to investigate the nursing staff in 14 third grade hospitals in 7 sub-districts nationwide.The bibliometric method was used for statistics of published research papers′ ethics committee approval and informed consent and other related items published in "Chinese Journal of Nursing", "Nursing Research", "Chinese Practical Nursing Journal", "Nursing Journal", "Nursing Training Magazine" from 2016-2018.Results:The ethical cognition total score of nursing staff was(70.93±3.04),and the ethical execution total score was(11.62±2.94).Nursing staff with different attitudes,training experiences,professional titles and departments had different ethics cognitive levels,and nursing staff with different training experiences,education,profession titles and attitude had different ethics implementation(P<0.05).The proportions of papers with ethics committee review and informed consent in the research papers was lower.Conclusions:Nursing staff′s ethical cognition and implementation status are not optimistic.Relevant management personnel should attach great importance to it,strive to improve the awareness of nursing staff on the importance of scientific research ethics,increase the training of nursing staff′s scientific ethics knowledge,and strictly implement inspection system of nursing research.In the ethical review system,professional journals should pay attention to the description of scientific ethics in the paper.
引文
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[17] 姚莉.临床医学科研与医学科研伦理探析[J].中国社会医学杂志,2009,26(6):335-337.
[2] 于沛沛,王丽宇.美国医学伦理委员会的发展及特点审视[D].沈阳:中国医科大学,2014.
[3] 滕黎,蒲川.我国生物医学伦理审查体系的构建研究[D].重庆:重庆医科大学管理学院,2010.
[4] 复旦大学医院管理研究所.2015年度最佳医院排行榜[EB/OL].[2016-12-20].http://www.Fudanmed.com/institute/news 2015-2.aspx.
[5] 国家卫生计生委办公厅.国家卫生计生委办公厅关于印发三级综合医院医疗服务能力指南(2016年版)的通知[EB/OL].[2016-08-29].http://www.nhfpc.gov.cn/ewebeditor/uploadfile/2016/10/20161020101032482.pdf.
[6] CZECH H,DRUML C,WEINDLING P.Medical ethics in the 70 years after the nuremberg code,1947 to the present[J].Wien klin Wochenschr,2018,130(3):159-253.
[7] IGNACIO M.Post-trial obligations in the declaration of helsinki 2013:classification,reconstruction and interpretation[J].Dev World Bioeth,2016,16(2):80-90.
[8] MIRACLE V A.The Belmont report:the triple crown of research ethics[J].DCCN,2016,35(4):223-228.
[9] 滕黎,蒲川.国外伦理委员会的监管对我国的启示[J].医学与哲学(人文社会医学版),2010,31(6):27-29.
[10] 田冬霞.中美伦理审查委员会管理机制之比较与分析[J].中国卫生事业管理,2009,26(9):642-644.
[11] 郑兴东,姜北,陆伟,等.医学科研伦理审查监管问题的思考[J].第二军医大学学报,2007,28(6):667-669.
[12] 叶家欣,黄峻.医学科研与医学科研伦理的辨证思考[J].医学与哲学(A),2008,29(5):30-32.
[13] 国家卫生计生委.涉及人的生物医学研究伦理审查办法[EB/OL].[2019-04-20].http://www.gov.cn/gongbao/content/2017/content_5227817.htm.
[14] 韩世范,程金莲.护理科学研究[M].北京:人民卫生出版社,2010:29-34.
[15] 国家食品药品监督管理总局.药品临床试验管理规范(局令第13号)[EB/OL].[2019-04-25].http://samr.cfda.gov.cn/WS01/CL0053/24493.html.
[16] 国家卫生计生委.涉及人的生物医学研究伦理审查办法(试行)[EB/OL].[2019-04-15].http://yxky.fudan.edu.cn/cc/ce/c6346a52430/page.htm.
[17] 姚莉.临床医学科研与医学科研伦理探析[J].中国社会医学杂志,2009,26(6):335-337.