Article(id=1292126385674413023, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.04.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1765123200000, receivedDateStr=2025-12-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996536891, onlineDateStr=2026-08-06, pubDate=1772208000000, pubDateStr=2026-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996536891, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996536891, creator=13701087609, updateTime=1785996536891, updator=13701087609, issue=Issue{id=1292126355785802497, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1772208000000', pubDateStr='2026-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996529766, creator='13701087609', updateTime=1786014519902, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201811952292026, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201811952292027, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=541, endPage=547, ext={EN=ArticleExt(id=1292126385888322528, articleId=1292126385674413023, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis of quality assessment tools for informed consent in clinical trials, columnId=1246531412438966969, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Reader’s Field, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate and analyze quality assessment tools for informed consent and provide a reference for selecting appropriate tools.
Methods A systematic search was conducted in Chinese and English databases, including CNKI, VIP, Wanfang, PubMed, Web of Science, and Embase, covering the period from database inception to July 23, 2025. Basic information on the included studies and assessment tools was extracted, and the dimensions covered by the tools as well as their reliability and validity were summarized.
Results A total of 23 articles and 18 informed consent quality assessment tools were included. The evaluations primarily focused on levels of understanding, information provision, and therapeutic misconception. The information content commonly addressed study objectives, study duration, procedural steps, risks and inconveniences, and potential benefits.
Conclusion Although numerous quality assessment tools for informed consent are available, many lack sufficient validation in terms of reliability and validity. Future research should prioritize the validation and refinement of existing tools while developing or introducing culturally adapted assessment instruments.
, authors=Liang-xiu LI
1, 4, Shi-yao SU
2, -Yu LI
3, Li-ying ZHANG
4, Hao-jing SONG
4, Cai-hui GUO
1, 4, authorsList=Liang-xiu LI, Shi-yao SU, -Yu LI, Li-ying ZHANG, Hao-jing SONG, Cai-hui GUO, authorCompany=null, correspAuthors=Cai-hui GUO, 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=1292126386114814945, articleId=1292126385674413023, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=临床试验受试者知情同意质量评价工具的分析, columnId=1246531414020219657, journalTitle=中国临床药理学杂志, columnName=读者园地, runingTitle=null, highlight=null, articleAbstract=
目的 对知情同意质量评价工具进行评价分析,为此类评价工具的选择提供参考。
方法 系统检索了中国知网、维普数据库、万方数据库、PubMed、Web of Science、Embase等中英文数据库,检索时限为建库至2025年7月23日,提取文献及评价工具的基本信息,将工具涵盖维度以及信效度情况进行梳理与汇总。
结果 共纳入23篇文献,18个知情同意质量评价工具。评估主要涉及理解程度、信息提供、治疗误解等方面,信息内容多涉及研究目的、持续时间、程序步骤、风险与不便、受益等。
结论 目前知情同意质量评价工具种类繁多,但许多工具信效度检验仍不完善。未来研究可进一步对现有知情同意质量评价工具进行验证和完善,并继续引入或研发本土化的知情同意质量评价工具。
, authors=黎良秀
1, 4, 苏诗尧
2, 李玉
3, 张丽英
4, 宋浩静
4, 郭彩会
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黎良秀(2002-),女,硕士研究生,从事临床药理及护理管理的工作和研究
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1.School of Nursing, Hebei Medical University, Shijiazhuang 050031, Hebei Province, China
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1.河北医科大学 护理学院,河北 石家庄 050031
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2, address=
2.School of Basic Medical sciences, Hebei Medical University, Shijiazhuang 050031, Hebei Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292126389013079032, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, authorId=1292126388870472693, language=CN, stringName=苏诗尧, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2.河北医科大学 基础医学院,河北 石家庄 050031, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292126386446164965, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, xref=2., ext=[AuthorCompanyExt(id=1292126386450359270, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, companyId=1292126386446164965, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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2.河北医科大学 基础医学院,河北 石家庄 050031)])]), Author(id=1292126389075993594, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292126389138908156, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, authorId=1292126389075993594, language=EN, stringName=-Yu LI, firstName=-Yu, middleName=null, lastName=LI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
3, address=
3.Department of Cardiovascular Medicine I, Hebei General Hospital, Shijiazhuang 050051, Hebei Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292126389210211325, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, authorId=1292126389075993594, language=CN, stringName=李玉, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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3.河北省人民医院 心内一科,河北 石家庄 050051, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292126386764932072, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, xref=3., ext=[AuthorCompanyExt(id=1292126386773320681, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, companyId=1292126386764932072, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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4, address=
4.Hebei General Key Laboratory of Clinical Pharmacy, Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, Hebei Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292126389428314113, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, authorId=1292126389298291711, language=CN, stringName=张丽英, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
4, address=
4.河北省人民医院 药学部,河北省临床药学重点实验室,河北 石家庄 050051, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292126386848818155, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, xref=4., ext=[AuthorCompanyExt(id=1292126386857206764, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, companyId=1292126386848818155, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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4, address=
4.Hebei General Key Laboratory of Clinical Pharmacy, Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, Hebei Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292126389629640710, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, authorId=1292126389487034371, language=CN, stringName=宋浩静, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
4, address=
4.河北省人民医院 药学部,河北省临床药学重点实验室,河北 石家庄 050051, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292126386848818155, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, xref=4., ext=[AuthorCompanyExt(id=1292126386857206764, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, companyId=1292126386848818155, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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1, 4, address=
1.School of Nursing, Hebei Medical University, Shijiazhuang 050031, Hebei Province, China
4.Hebei General Key Laboratory of Clinical Pharmacy, Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, Hebei Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292126389860327436, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292126385674413023, authorId=1292126389705138184, language=CN, stringName=郭彩会, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, 4, address=
1.河北医科大学 护理学院,河北 石家庄 050031
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