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 LI1, 4, Shi-yao SU2, -Yu LI3, Li-ying ZHANG4, Hao-jing SONG4, Cai-hui GUO1, 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1, 4, authorsList=黎良秀, 苏诗尧, 李玉, 张丽英, 宋浩静, 郭彩会, authorCompany=null, correspAuthors=郭彩会, authorNote=

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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郭彩会,主任护师,硕士生导师 Tel: 18031108868 E-mail:
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临床试验受试者知情同意质量评价工具的分析
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黎良秀 1, 4 , 苏诗尧 2 , 李玉 3 , 张丽英 4 , 宋浩静 4 , 郭彩会 1, 4
中国临床药理学杂志 | 读者园地 2026,42(4): 541-547
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中国临床药理学杂志 |读者园地 2026 , 42 (4) : 541 -547
临床试验受试者知情同意质量评价工具的分析
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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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黎良秀1, 4, 苏诗尧2, 李玉3, 张丽英4, 宋浩静4, 郭彩会1, 4
作者信息
  • 1.河北医科大学 护理学院,河北 石家庄 050031
  • 2.河北医科大学 基础医学院,河北 石家庄 050031
  • 3.河北省人民医院 心内一科,河北 石家庄 050051
  • 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
通讯作者:
郭彩会,主任护师,硕士生导师 Tel: 18031108868 E-mail:
作者简介:

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

Analysis of quality assessment tools for informed consent in clinical trials
Liang-xiu LI1, 4, Shi-yao SU2, -Yu LI3, Li-ying ZHANG4, Hao-jing SONG4, Cai-hui GUO1, 4
Affiliations
  • 1.School of Nursing, Hebei Medical University, Shijiazhuang 050031, Hebei Province, China
  • 2.School of Basic Medical sciences, Hebei Medical University, Shijiazhuang 050031, Hebei Province, China
  • 3.Department of Cardiovascular Medicine I, Hebei General Hospital, Shijiazhuang 050051, Hebei Province, China
  • 4.Hebei General Key Laboratory of Clinical Pharmacy, Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, Hebei Province, China
出版时间: 2026-02-28 doi: 10.13699/j.cnki.1001-6821.2026.04.014
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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。

临床试验  /  知情同意  /  评价工具  /  范围综述
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.

clinical trials  /  informed consent  /  assessment tools  /  scope review
黎良秀, 苏诗尧, 李玉, 张丽英, 宋浩静, 郭彩会. 临床试验受试者知情同意质量评价工具的分析. 中国临床药理学杂志, 2026 , 42 (4) : 541 -547 . DOI: 10.13699/j.cnki.1001-6821.2026.04.014
Liang-xiu LI, Shi-yao SU, -Yu LI, Li-ying ZHANG, Hao-jing SONG, Cai-hui GUO. Analysis of quality assessment tools for informed consent in clinical trials[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (4) : 541 -547 . DOI: 10.13699/j.cnki.1001-6821.2026.04.014
  • 河北省医学科学研究课题计划基金资助项目(20260060)
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2026年第42卷第4期
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文章信息
doi: 10.13699/j.cnki.1001-6821.2026.04.014
  • 接收时间:2025-12-08
  • 首发时间:2026-08-06
  • 出版时间:2026-02-28
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  • 收稿日期:2025-12-08
基金
河北省医学科学研究课题计划基金资助项目(20260060)
作者信息
    1.河北医科大学 护理学院,河北 石家庄 050031
    2.河北医科大学 基础医学院,河北 石家庄 050031
    3.河北省人民医院 心内一科,河北 石家庄 050051
    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

通讯作者:

郭彩会,主任护师,硕士生导师 Tel: 18031108868 E-mail:
参考文献
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.04.014
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2种不同金属材料的力学参数

Family
属数
Number of
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种数
Number of
species
占总种数比例
Percentage of
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Genus
种数
Number of
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占总种数比例
Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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