Article(id=1292135547795952219, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.015, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1777478400000, receivedDateStr=2026-04-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998721312, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998721312, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998721312, creator=13701087609, updateTime=1785998721312, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1443, endPage=1450, ext={EN=ArticleExt(id=1292135547988890204, articleId=1292135547795952219, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Investigation and analysis of the current status of safety review by Drug Clinical Trial Ethics Committees in China: A cross-sectional survey, columnId=1246531412438966969, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Reader’s Field, runingTitle=null, highlight=null, articleAbstract=
Objective To investigate the current status of safety review by institutional review boards (IRBs) for clinical drug trials in China, analyze existing issues and needs for improvement, and provide a basis for enhancing the quality and efficiency of ethical review.
Methods An online questionnaire survey was conducted from May 2025 to March 2026, targeting 391 IRBs for clinical drug trials across 29 provinces, municipalities, and autonomous regions nationwide. The questionnaire covered the basic profile of the ethics committees, requirements for submitting safety reports and review processes, as well as attitudes toward the need for improvements in the review process. SPSS AU was used to perform descriptive statistics, analysis of variance (ANOVA), correlation analysis, and post-hoc analysis. The results showed that the questionnaire had good reliability and validity (Cronbach’s α=0.932, KMO=0.946).
Results 86.7% of the drug clinical trial ethics committees explicitly stipulated in their SOPs the selection criteria and decision-makers for the review method of safety reports; however, implementation was inconsistent at critical stages, with a portion (46.04%) of the committees not having the chairperson decide on the selection of the lead reviewer. Regarding serious adverse events (SAEs), 94.63% of drug clinical trial ethics committees required the principal investigator to submit reports; however, there were discrepancies in the interpretation of the provisions of the "Good Clinical Practice for Drug Clinical Trials" (2020) (48.85% believed that only suspected and unexpected adverse reactions needed to be reviewed). 59.34% of ethics committees updated the types of review conclusions in a timely manner to be consistent with the "Measures for Ethical Review of Life Sciences and Medical Research Involving Humans" (2023). The results showed that there was no significant difference in the recognition of all improvement suggestions among the levels of different health institutions, investigators’ working years, professional backgrounds and technical titles, proving that the industry has a common and consistent demand for improving ethical standardization review. Correlation analysis shows that various improvement measures are closely related. Among them, the "Standard Operating Procedures for the Establishment and Review of Ethics Committees" and the "Application Guidelines for Institutional Establishment" showed a strong positive correlation (r=0.716, P<0.01), and various measures were positively correlated with "supervision by superior authorities" (r=0.407~0.705, P<0.01), highlighting the need for systematic optimization.
Conclusion Our country’s ethical review system for drug clinical trial safety reports has been initially established, but it needs to be strengthened in terms of uniformity of review standards, timely implementation of regulations and standardization of process operations. This survey results show that in the future, efforts should be made to build a four-in-one systematic optimization plan of "regulations-standards-capabilities-supervision" to unify industry standards, improve review efficiency, and effectively protect the rights and interests of research participants.
, authors=Fei CHEN
1, Ji-yin ZHOU
2, authorsList=Fei CHEN, Ji-yin ZHOU, authorCompany=null, correspAuthors=Ji-yin ZHOU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292135548307657309, articleId=1292135547795952219, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=药物临床试验伦理委员会安全性审查现状与分析, columnId=1246531414020219657, journalTitle=中国临床药理学杂志, columnName=读者园地, runingTitle=null, highlight=null, articleAbstract=
目的 调查我国药物临床试验伦理委员会对安全性审查的现状，分析存在的问题和改进需求，为提升伦理审查质量与效率提供依据。
方法 采用线上问卷调查的方法，在2025年5月至2026年3月，对全国29个省市自治区391家医疗卫生机构的药物临床试验伦理委员会进行问卷调查。问卷内容包括伦理委员会基本情况、安全性报告递交要求与审查流程以及对改进审查的需求态度。使用SPSS AU对数据进行描述性统计、方差分析、相关性分析以及事后分析。结果显示问卷信度和效度良好（Cronbach’s α=0.932，KMO=0.946）。
结果 86.70%的药物临床试验伦理委员会在标准操作规程中明确规定了安全性报告的审查方式的选择标准和决定人员，但在关键环节上执行不一致，一部分（46.04%）伦理委员会对主审委员的选择未由主任委员决定。对于严重不良事件（SAE），94.63%的伦理委员会要求主要研究者递交，但对《药物临床试验质量管理规范》（2020）条款的理解存在分歧（48.85%认为仅需审查可疑且非预期的严重不良反应）。59.34%伦理委员会及时更新了审查结论的类型，与《涉及人的生命科学和医学研究伦理审查办法》（2023）保持一致。不同医疗卫生机构的级别、调查人员的工作年限、专业背景及技术职称对所有改进建议的认同度均没有显著差异，证明行业对提升伦理规范化审查具有普遍且一致的诉求。相关性分析显示，各项改进措施是紧密关联的。其中，“伦理委员会建立审查标准操作规程”与“机构建立申请指南”显示出强正相关（r=0.716，P<0.01），并且各项措施均与“上级主管部门监督”呈正相关（r=0.407~0.705，P<0.01），凸显了系统性优化的必要性。
结论 我国药物临床试验安全性报告的伦理审查体系已建立，但在审查标准统一性、法规执行及时性和流程操作规范性等方面有待进一步加强。未来应当致力于构建一个“法规-标准-能力-监督”四位一体的系统性的优化方案，统一行业标准，提升审查质量，切实保障试验参与者的安全。
, authors=陈飞
1, 周吉银
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陈飞（1988-），男，主管药师，主要从事医学伦理审查工作和研究
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