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Analysis of quality assessment tools for informed consent in clinical trials
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Liang-xiu LI1, 4, Shi-yao SU2, -Yu LI3, Li-ying ZHANG4, Hao-jing SONG4, Cai-hui GUO1, 4
Chinese Journal of Clinical Pharmacology | 2026, 42(4) : 541 - 547
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Chinese Journal of Clinical Pharmacology | 2026, 42(4): 541-547
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Analysis of quality assessment tools for informed consent in clinical trials
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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
Published: 2026-02-28 doi: 10.13699/j.cnki.1001-6821.2026.04.014
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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
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
Year 2026 volume 42 Issue 4
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Article Info
doi: 10.13699/j.cnki.1001-6821.2026.04.014
  • Receive Date:2025-12-08
  • Online Date:2026-08-06
  • Published:2026-02-28
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History
  • Received:2025-12-08
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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
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表12种不同金属材料的力学参数

Family
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Number of
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Number of
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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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