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

中华医学科研管理杂志 Pub Date : 2019-06-21 DOI:10.3760/CMA.J.ISSN.1006-1924.2019.03.003

Miaomiao Ye, Hailing Liu, Yuan Chen

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Abstract

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. Key words: Ethical review; Informed consent of subjects; Biomedical research; Clinical trial involving human subject; Subjects

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医院人体临床试验知情同意与伦理审查现状分析及对策

目的探讨医院人体临床试验知情同意和伦理审查的现状，并提出相应的对策。方法检索网站（http://med.wanfangdata.com.cn/Paper），选择“医院”作为检索词，以“所有字段”作为检索条件。收集的论文是关于2018年1月至2018年2月在内科、外科、妇产科和儿科发表的涉及人类受试者的临床试验。从医院级别、医疗机构类型、临床研究方法、研究类型、基金项目、期刊类别等方面分析了这些论文的知情同意和伦理审查现状。结果（1）在1964篇论文中，只有538篇（27.4%）获得了受试者的知情同意和伦理审查批准。（2）不同医院级别和不同医疗机构在知情同意和伦理审查方面没有显著差异。（3）实验研究比观察性研究更侧重于知情同意和伦理审查。（4）与非药物相关的临床研究相比，药物临床试验更多地关注知情同意和伦理审查。（5）基金项目比非基金项目更注重知情同意和道德审查。（6）发表在核心期刊上的论文比发表在其他期刊上的文章更关注知情同意和伦理审查。结论目前开展人体临床试验对受试者的知情同意和伦理审查还不够重视，需要采取更多的对策来改变现状，规范人体临床试验。关键词：伦理审查；受试者的知情同意书；生物医学研究；涉及人体受试者的临床试验；受试者

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中华医学科研管理杂志

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