摘要
目的了解儿科医护人员对临床研究伦理审查申报的认知和需求。方法自行设计调查问卷,内容包括一般资料、所在医院医学伦理审查委员会信息以及对伦理审查的需求共3个方面23个问题。应用百度在线调查服务器制作在线点击的网络问卷,设定调查样本量为200位儿科医护人员,由参与调查者采用匿名、自愿完成在线调查问卷并点击回复。采用SPSS20. 0软件对数据进行Logistic回归分析等统计学分析。结果共收回有效问卷198份。参与本问卷调查的医护人员多数有主持科研课题(112/198)和伦理审查申报经历(100/112)。所在医院大多设立了IRB(168/198),但很少获得资质认证。儿科医护人员对IRB需求程度最高的为需要伦理专家的咨询服务、对研究对象补偿的界定、定期进行伦理审查申报辅导。大多不认为IRB是个找麻烦的机构、不同意IRB以收费方式保证审批速度。研究生和新生儿科医护更需要伦理专家的咨询服务;认为IRB是个找麻烦的机构的危险因素是护士、新生儿科医护、课题级别低、IRB审批时间需要8周以上; IRB审批时间需要8周以上是需要专业人员代办申报事宜、需要定期进行伦理审查申报辅导的危险因素;所在医院IRB有专职工作人员能显著降低伦理审查申报纸质文档写作难度、申报时集中答辩的难度和受试者知情同意书写作难度。结论大多数医院设立了IRB,但很少获得资质认证。儿科医护人员对临床研究伦理审查已有较好的认知,迫切需求伦理专家的咨询服务、界定对研究对象的补偿和定期进行伦理审查申报辅导。大多不同意IRB以收费方式保证审批速度。IRB审批时间最好小于8周。
Objective： To understand pediatric medical staff’s cognition and needs on the declaration of clinical research ethical review. Methods： The questionnaire was self-designed, and the contents with 23 questions included three aspects of general information, the information of the hospitals institutional review board （IRB）, and the need for ethical review. This paper applied Baidu online survey server to create an online questionnaire for online clicks, and set the survey sample size to 200 pediatric medical staff. The survey participants finished online questionnaires anonymously and voluntarily and clicked to reply. SPSS20.0 software was used conducted logistic regression analysis and other statistical analyses. Result： A total of 198 valid questionnaires were recovered. Most of medical staff involved in this survey had hosted research projects （112/198） and ethical review application experience （100/112）. Most hospitals of the participants had established IRB （168/198） but rarely obtained qualification certification. The highest levels of needs of pediatric medical staff to IRBs were the need for ethics experts counseling services, the definition of compensation for research subjects, and periodical ethical review application training. Most participants did not consider that IRB is a troublesome institution, and disagreed that IRB guarantees the approval speed by the method of charging. Postgraduate and medical staff in neonatology needed more ethics expert’ consulting services; the high risk factors for considering that IRB is troublesome institution were nurses, medical staff in neonatology, low level of project, and IRB approval time of more than 8 weeks; IRB approval time of more than 8 weeks was the risk factor for needing professional agents to apply for approval and for needing periodical ethical review application trainings; the hospital IRB having full-time staff can significantly reduce the difficulty of writing ethical review paper documents, the difficulty of centralized de
作者
黑明燕
高翔羽
刘玲
向西盈
欧阳志翠
林振浪
HEI Mingyan;GAO Xiangyu;LIU Ling;XIANG Xiying;OUYANG Zhicui;LIN Zhenlang(Neonatal Center, Beijing Children＇s Hospital, Capital Medical University, Beijing 100045, China, E-mail： heiming_yan@163.com;Children Diagnosis and Treatment Center, the Affiliated Xuzhou Hospital of Southeast University, Xuzhou 221009, China;Department of Neonatology, Guiyang Maternal and Child Healthcare Hospital, Guiyang 550003, China;Department of Pediatrics, the Third Xiangya Hospital of Central South University, Changsha 410013, China;Department of Neonatology, the Second Affiliated Hospital and Yuying Children＇s Hospital of Wenzhou Medical University, Wenzhou 325027, China)
出处
《中国医学伦理学》
2018年第10期1281-1288,共8页
Chinese Medical Ethics
基金
Canadian Institutes of Health Research:CIHR Team in Maternal Infant Care(CTP 87518)
