医院开展人体试验中知情同意及伦理审查现状与对策  

Current situation analysis and countermeasures of informed consent and ethical review about clinical trial involving human subject in hospitals

作　　者：叶苗苗 刘海玲 陈苑[1] 朱雪琼[1] Ye Miaomiao;Liu Hailing;Chen Yuan;Zhu Xueqiong(The Second Affiliated Hospital of Wenzhou Medical University , Wenzhou 325027 ,China)

机构地区：[1]温州医科大学附属第二医院,325027

出　　处：《中华医学科研管理杂志》2019年第3期169-175,共7页Chinese Journal of Medical Science Research Management

摘　　要：目的探讨医院开展涉及人的生物医学研究时的受试者知情同意及伦理审查现状,并提出相应的改进措施。方法通过检索万方医学网(http://med.wanfangdata.com.cn/Paper),选取"医院"作为检索词,以"全部字段"作为检索条件,收集刊登时间为2018.01-2018.02,内外妇儿领域中涉及人的生物医学研究的相关文章,从发表文章所属医院等级、医疗机构类型、试验开展所采用的临床研究方法、是否属于药物相关临床研究、试验项目基金资助、发表文章刊登的杂志类型等不同角度,分析医院人体试验开展中受试者知情同意书签署及伦理委员会审查情况。结果(1)在1 964篇涉及人的生物医学研究的文章中,试验开展得到受试者知情同意及通过伦理委员会审查的仅538篇,占27.4%。(2)不同等级医院、不同医疗机构发表的文章,在人体试验开展中落实受试者知情同意及伦理审查方面无明显差异。(3)试验性研究比观察性研究更加重视受试者知情同意及伦理审查。(4)药物相关性临床研究比非药物相关性临床研究更加重视受试者知情同意及伦理审查。(5)受基金资助的项目比不受基金资助的项目更加重视受试者知情同意及伦理审查。(6)文章收录在核心期刊较收录在其他期刊的研究更加重视受试者知情同意及伦理审查。结论目前,医院在开展涉及人的生物医学研究时,对受试者知情同意及伦理审查仍然不够重视,医务人员伦理意识尚薄弱,需进一步改进以规范人体试验的科学开展。Objective To explore the current situation of informed consent and ethical review of clinical trial involving human subject in hospitals, and provide related countermeasures. Methods This study searches the website (http://med.wanfangdata.com.cn/Paper), selects "hospital" as the search term, and uses "all fields" as the search criteria. Collected papers were about clinical trial involving human subject that published during Jan. 2018 to Feb. 2018 in internal medicine, surgery, obstetrics and gynecology, pediatrics. The current situation of informed consent and ethical review of these papers were analyzed from various aspects, including the hospital grades, medical institutions types, clinical research methods, study types, fund projects, periodical category. Results (1) Among 1964 papers, only 538 (27.4%) papers obtained informed consent of subjects and the ethical review approval.(2) There are no significant differences between different hospital grades, and different medical institutions about informed consent and ethical review.(3) Experimental studies focus more on informed consent and ethical review than observational studies.(4) Drug clinical trials focuses more on informed consent and ethical review than non - drug related clinical study.(5) Fund projects focus more on informed consent and ethical review than non-fund projects.(6) Papers published in core periodical focus more on informed consent and ethical review than papers published in other periodical. Conclusions Currently, conducting clinical trial involving human subject still does not pay enough attention to the informed consent of subjects and ethical review, more countermeasures are needed to change the current situation and to standardize human clinical trials.

关 键 词：伦理审查 受试者知情同意 生物医学研究 临床人体试验 受试者 

分 类 号：R197.323[医药卫生—卫生事业管理]