临床研究者对临床研究利益冲突认知的探讨  

Preliminary Analysis on Conflicts of Interest in Clinical Research from Investigators' Cognition

作　　者：张兆金[1] 赖永洪[2] 王练深[3] 刘世明[4] 黄锦坤[5] 黄庆晖[6] 廖绮霞[7] 莫红缨[6] 刘晓绛[1] 

机构地区：[1]广州医科大学附属第三医院医务科,广东广州510150 [2]广州医科大学附属第三医院,广东广州510150 [3]广州医科大学附属第三医院办公室,广东广州510150 [4]广州医科大学附属第二医院,广东广州510260 [5]广州医科大学附属第一医院,广东广州510120 [6]广州医科大学附属第一医院广州呼吸疾病研究所,广东广州510120 [7]广州医科大学附属第三医院医疗质量管理评价科,广东广州510150

出　　处：《医学与哲学（A）》2016年第4期15-20,共6页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：广东省医师协会人文医学工作委员会对本研究工作的支持

摘　　要：通过对广州数家高校附属医院的临床研究者进行问卷调查,分析临床研究者对临床研究中利益冲突的认知情况。利益冲突的主要环节表现在不良事件的处置、研究对象隐私保护、研究对象的选择和分组等。原因主要有研究者的工作压力大、研究方案的不足、研究者注重自身工作便利、伦理审查不够严格等。并提出了重点防范有直接诊疗关系的研究者与研究对象的利益冲突;提高临床研究者对研究对象利益保护的意识;建立临床研究管理体系,对临床研究进行全面的审查、监督、管理;减轻研究者的研究压力,为研究者创造适宜的研究环境的针对性对策。This paper conducted a questionnaire survey on clinical investigators in several university affiliated hospitals of Guangzhou. Based on the investigation, this paper analyzed clinical investigators＇ cognition of the conflicts of interest in clinical research. The results showed that the conflicts of interest mainly existed in the aspects of the disposal of adverse events, the protection of participants＇ privacy, and the selection and grouping of participants. The major causes of the conflicts of interest included the big research pressure of investigators, the defect of research design, investigators concerning of convenience of themselves and the lack of rigorous ethical review. In addition, some countermeasures were proposed, including paying more attentions to the management of conflicts of interest between the clinical investigators and participants who had a direct treatment relationship; improving clinical investigators＇ consciousness of protection of participants~ interest; establishing clinical research management system which conducted comprehensive review and supervision of the researches; reducing the clinical investigators＇ stress in order to create a sound research environment.

关 键 词：临床研究 临床研究者 研究对象 利益冲突 

分 类 号：R-052[医药卫生]