加强伦理审查委员会实效性的对策探讨——基于黑龙江省伦理审查委员会现状的调研  

Countermeasures on Enhancing the Effectiveness of Institutional Review Board——According to the Analysis of Institutional Review Board of Heilongjiang Province

作　　者：毕子豪 尹梅[1] 张雪[1] 周京[1] 

机构地区：[1]哈尔滨医科大学人文社会科学学院,黑龙江哈尔滨150081

出　　处：《中国医学伦理学》2014年第5期617-619,共3页Chinese Medical Ethics

基　　金：2013年地方高校国家级大学生创新创业计划训练项目"伦理审查委员会(IRB)伦理审查现状调查报告--以黑龙江省为例"(编号:201310226004);中华医学会医学教育分会2012年度医学教育研究立项课题<医学生医患沟通能力培养的研究>(编号:2012-RW-47)

摘　　要：通过对黑龙江省部分伦理审查委员会的问卷调查分析,发现目前伦理审查委员会的整体效果不甚理想,主要存在伦理审查内容混杂、伦理审查的全程性未得到相应重视、组织建设有待完善等问题。其制约因素有:现行相关法律位阶较低、监管制度不完善、操作流程不规范。在对制约因素进行分析的基础上,提出了加强伦理审查委员会实效性的对策:提高有关法律位阶并完善相关规定,建立统一的监管主体,完善伦理审查程序,改善组织建设。By analyzing the questionnaire survey of institutional review board （IRB） in Heilongjiang province partly,the overall effect of IRB is not good enough.Furthermore there are many defects such as ethical review content lack of standardization,the whole process of the ethical review has not been corresponding attaches great importance to,organization construction has problems,and so forth.The constraints factors are：low current related legal status,imperfect supervision system,the operation is not standard.On the basis of analyzing the restricting factors and puts forward the countermeasures to strengthen ethical review committee effectiveness,improve the legal status and improve relevant regulations,to establish a unified regulatory body,perfect the ethics review process,improve the organization construction.

关 键 词：伦理审查委员会 法律位阶 组织建设 医学研究 医药卫生 

分 类 号：R-052[医药卫生]