Comparative Study on Informed Consent Clauses in Drug Clinical Trial Regulations Between China, America and European Union

Huan Jing, Ni Qi, Liu Yi

Chinese Pharmaceutical Affairs ›› 2025, Vol. 39 ›› Issue (3) : 266-271.

PDF(986 KB)
PDF(986 KB)
Chinese Pharmaceutical Affairs ›› 2025, Vol. 39 ›› Issue (3) : 266-271. DOI: 10.16153/j.1002-7777.2024-08-0044
Supervision & Administration

Comparative Study on Informed Consent Clauses in Drug Clinical Trial Regulations Between China, America and European Union

Author information +
History +

Abstract

Objective: To provide reference for optimizing and improving the supervision of informed consent in clinical trials in China by drawing on the informed consent clauses in European Union's and American regulations. Methods: The informed consent clauses in drug clinical trials regulations between China, America and European Union were compared to identify the differences among them, and the suggestions were put forward to improve the regulations of informed consent in China. Results: The core management elements of the informed consent process in the regulations of China, America and European Union were basically the same, but there was some different emphases in terms of the level of detail, language, signing process, etc. Conclusion: It is suggested that China should improve the legal system of informed consent, formulate a consensus on informed consent, strengthen the awareness of subject protection of researchers and further enhance the management of ethical review and quality control, so as to promote the improvement of the legal system of informed consent and the protection system of subjects' rights.

Key words

China / America / European Union / drug clinical trial / informed consent

Cite this article

Download Citations
Huan Jing, Ni Qi, Liu Yi. Comparative Study on Informed Consent Clauses in Drug Clinical Trial Regulations Between China, America and European Union[J]. Chinese Pharmaceutical Affairs, 2025, 39(3): 266-271 https://doi.org/10.16153/j.1002-7777.2024-08-0044

References

[1] 项玉霞,黄志军,刘畅,等. 中国特色药物临床试验机构质量管理体系建设[J]. 中国临床药理学杂志,2017,33(11):1039-1041.
[2] 国家药品监督管理局,国家卫生健康委员会. 药物临床试验质量管理规范[S]. 2020.
[3] FDA. 21 CFR Part 50 Subpart B[EB/OL]. (1981-01-27)[2024-07-01]. https://www.ecfr.gov/current/title-21/part-50/subpart-B.
[4] FDA. 21 CFR Part 50 Subpart D[EB/OL]. (2001-04-24)[2024-07-01]. https://www.ecfr.gov/current/title-21/part-50/subpart-D.
[5] EMA. Clinical Trials on Medicinal Products for Human Use[EB/OL]. (2014-04-16)[2024-07-01]. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0536.
[6] 陈苑. 医院药物临床试验知情同意制度实施问题研究——以温州市某公立医院为例[D]. 上海师范大学公共管理,2022.
[7] 柳沁怡,姜柏生. 临床试验中知情同意书的简化问题研究[J]. 医学与哲学,2017,38(5):30-33.
[8] Wen G, Liu X, Huang L, et al.Readability and Content Assessment of Informed Consent Forms for Phase Ⅱ - Ⅳ Clinical Trials in China[J]. PloS one, 2016,11(10): e164251.
[9] 谢江川,郭薇,谢林利,等. 药物临床试验知情同意过程中的常见问题及对策[J]. 中国医学伦理学,2021,34(7):835-838.
[10] 王美霞,李义庭. 我国药物临床试验知情同意政策的变迁——从2003版与2020版GCP的对比说起[J]. 医学与哲学,2020,41(15):12-19.
[11] 刘炫麟. 受试者知情同意伦理审查中的法律要点[J]. 中国医学伦理学,2022,35(11):1188-1195,1213.
[12] 郭岩岩,张雪,马佳乐,等. 美国人体研究知情同意对我国的启示[J]. 中国医学伦理学,2019,32(1):42-45.
[13] 马大力,邓蕊. 日本药物临床试验知情同意发展状况及启示[J]. 医学与哲学,2019,40(7):46-51.
[14] 郑小敏,刘艺群,翁小香,等. 临床试验中知情同意常见问题分析[J]. 海峡药学,2022,34(5):152-153.
[15] 耿雯倩,耿苗苗,李宪辰,等. 伦理审查视角下临床研究知情同意书质量分析[J]. 中国医院管理,2022,42(2):64-68.
[16] 王安娜,李见明,钱雪,等. 2008年至2015年欧盟药物临床试验检查情况分析[J]. 中国新药与临床杂志,2017,36(4):196-202.
PDF(986 KB)

73

Accesses

0

Citation

Detail

Sections
Recommended

/