Article(id=1236700468492169973, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1650384000000, acceptedDateStr=2022-04-20, onlineDate=1772781968472, onlineDateStr=2026-03-06, pubDate=1681488000000, pubDateStr=2023-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772781968472, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772781968472, creator=13701087609, updateTime=1772781968472, updator=13701087609, issue=Issue{id=1236700465119949418, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='7', pageStart='657', pageEnd='760', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772781967668, creator=13701087609, updateTime=1772782901622, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236704382474047808, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236704382474047809, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=724, endPage=727, ext={EN=ArticleExt(id=1236700468752216834, articleId=1236700468492169973, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Discussion of the problems existing in the qualification of principal investigator in ethical review clinical research, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

In the ethical review of the qualification of principal investigators, some problems such as insufficient certification materials to fully reflect the qualification of principal investigator, lack of qualification standard system of principal investigator, simple review method and single form, insufficient attention, weak awareness and low degree of independence were found. To further standardize the operation of the ethics committee and to improve the comprehensive review capacity, it is suggested to clearly specify the certification materials for qualification submission, building a comprehensive evaluation index system of qualification, taking a variety of review forms and strengthening the capacity-building of the ethics committee, so as to provide experience and reference.

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药物临床研究伦理审查主要研究者资质中存在证明材料不足以全面体现主要研究者资质、缺乏主要研究者资质标准的评估体系、审查方式简单与形式单一、重视程度不够、意识不强、独立性程度不高等问题，建议采取明确规定资质证明递交的材料、构建资质综合评价指标体系、多种审查形式相结合以及加强伦理委员会能力建设等措施，进一步为规范伦理委员会运行与提升综合审查能力提供经验借鉴。

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吴爵，男，硕士，研究方向：临床研究管理、医学伦理学。联系电话：(028)83016976，E-mail: 365438559@qq.com。

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吴爵，男，硕士，研究方向：临床研究管理、医学伦理学。联系电话：(028)83016976，E-mail: 365438559@qq.com。

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