ISSN 2097-6046（网络）
ISSN 2096-7446（印刷）
CN 10-1655/R
主管：中国科学技术协会
主办：中华护理学会
中华急危重症护理杂志

中华急危重症护理杂志 >

2025 , Vol. 6 >Issue 9: 1050 - 1054

DOI: https://doi.org/10.3761/j.issn.2096-7446.2025.09.004

述评

护理临床研究伦理审查的挑战及对策

  • 李继红 ,
  • 王爽
展开
  • 100038 北京市 首都医科大学附属北京世纪坛医院伦理委员会办公室（李继红），感染管理处/疾病预防控制处（王爽）
李继红：女，硕士，副研究员，伦理委员会办公室主任，E-mail：lijihong@bjsjth.cn
王爽，E-mail：wangshuang@bjsjth.cn

收稿日期: 2025-03-20

  网络出版日期: 2025-09-02

收起

Challenges and recommendations for ethical review in nursing clinical research

  • LI Jihong ,
  • WANG Shuang
Expand

Received date: 2025-03-20

  Online published: 2025-09-02

Fold

摘要

该文系统剖析了医疗机构护理临床研究伦理审查现存的六大核心挑战：护理研究者伦理意识薄弱、项目设计伦理考量缺失、研究参与者权益保护不足、隐私保护机制不完善、利益冲突识别能力欠缺及新兴技术伦理边界模糊；提出“四维提升”策略，构建“护理管理—科研管理—临床研究/质量促进中心—伦理委员会”四方联动机制，实施动态风险评估和过程监管。通过以上实践策略，有望提升护理伦理审查效率，构建覆盖全链条的伦理管理体系，为形成“护理临床研究伦理审查操作指引”提供循证依据，提升护理科研伦理水平，完善我国护理科研伦理治理体系。

关键词： 护理研究者; 护理临床研究; 伦理审查; 伦理学; 护理学

本文引用格式

李继红 , 王爽 . 护理临床研究伦理审查的挑战及对策[J]. 中华急危重症护理杂志, 2025 , 6(9) : 1050 -1054 . DOI: 10.3761/j.issn.2096-7446.2025.09.004

Abstract

This article systematically analyzes the six core challenges in the ethical review of clinical nursing research in medical institutions：weak ethical awareness among nursing researchers，lack of ethical considerations in project design，insufficient protection of the rights and interests of research participants，incomplete privacy protection mechanisms，lack of ability to identify conflicts of interest，and blurred ethical boundaries of emerging technologies. A targeted “four-dimensional improvement” strategy is proposed，and a four party linkage mechanism of “nursing management-research management-clinical research/quality promotion center-ethics committee” is constructed to implement dynamic risk assessment and process supervision. Through the above practical strategies，it is expected to enhance the ethical review in nursing research，establish an ethical management system covering the entire chain，provide evidence-based basis for the formation of the “Guidelines for Ethical Review of Nursing Clinical Research”，improve the ethical level of nursing research，and perfect the ethical governance system of nursing research in China.

Key words： Nursing Researcher; Nursing Clinical Research; Ethical Review; Ethics; Nursing

参考文献

[1] 胡雁, 王志稳. 护理研究[M]. 第6版. 北京: 人民卫生出版社,2022:1-3.
  Hu Y, Wang ZW. Nursing Research[M]. Version 6. Beijing: Peo-ple’s Medical Publishing House,2022:1-3.
[2] 科技部, 教育部, 工业和信息化部, 等. 《科技伦理审查办法(试行)》[EB/OL]. (2023-09-07)[2025-03-18]. https://www.gov.cn/gongbao/2023/issue_10826/202311/content_6915814.html.
  Ministry of Science and Technology,Ministry of Education, Ministry of Industry and Information Technology, et al. Administrative measures for ethical review of science and technology(trial)[EB/OL]. (2023-09-07)[2025-03-18]. https://www.gov.cn/gongbao/2023/issue_10826/202311/content_6915814.html.
[3] 程金莲, 韩世范, 褚银平, 等. 护理人员科研伦理实施过程中存在的问题及对策研究[J]. 护理研究, 2019, 33(13):2192-2197.
  Cheng JL, Han SF, Chu YP, et al. Study on exiting problems and countermeasures during implemention of scientific research ethics of nursing staff[J]. Chin Nurs Res, 2019, 33(13):2192-2197.
[4] 李玉姣, 程金莲, 谭茜. 护理人员科研伦理认知现状及影响因素分析[J]. 护理研究, 2017, 31(17):2111-2116.
  Li YJ, Cheng JL, Tan X. Analysis of status quo of scientific research ethics of nurses and its influencing factors[J]. Nurs Res China, 2017, 31(17):2111-2116.
[5] Seidlein AH, Breimaier HE, Wefer F, et al. Nursing research at German university hospitals:A descriptive,cross-sectional study on the current status of nursing research activities and challenges for ethical approval[J]. Z Evid Fortbild Qual Gesundhwes, 2024,190-191:5-12.
[6] 胡雁. 新时期护理研究的范畴、选题与科研伦理思考[J]. 中华现代护理杂志, 2024, 30(1):2-6.
  Hu Y. Nursing research in the new era:scope,trends and ethical consideration[J]. Chin J Mod Nurs, 2024, 30(1):2-6.
[7] 杨建梅, 林桂如, 欧婉仪, 等. 多组学技术在临床护理研究中的应用进展[J]. 中华护理杂志, 2024, 59(16):2044-2049.
  Yang JM, Lin GR, Ou WY, et al. Application progress of multi-omics technology in clinical nursing research[J]. Chin J Nurs, 2024, 59(16):2044-2049.
[8] Kane C, Sakaguchi S, Chuma M, et al. Research ethics consultation in nursing studies[J]. J Empir Res Hum Res Ethics, 2022, 17(1/2):63-69.
[9] Pittelkow MM, Strech D. Resources to aid ethical review of clinical studies:an exploratory scoping review identifying gaps and opportunities[J]. Trials, 2025, 26(1):77.
[10] Sakaida Y, Ota K, Sone C. The role of nursing members in research ethics committees in Japan[J]. Nagoya J Med Sci, 2022, 84(4):813-824.
[11] 王思洁, 杨梦婕, 乔雯俐, 等. 研究型医院面临的科技伦理治理的挑战与对策[J]. 中国医学伦理学, 2023, 36(8):829-833.
  Wang SJ, Yang MJ, Qiao WL, et al. Challenges and countermeasures of science and technology ethics governance faced by research-oriented hospitals[J]. Chin Med Ethics, 2023, 36(8):829-833.
[12] 陈琼, 程金莲, 韩世范, 等. 护理人员护理科研伦理培训效果研究[J]. 循证护理, 2019, 5(8):730-733.
  Chen Q, Cheng JL, Han SF, et al. Study on effectiveness of nursing research ethics training for nursing staff[J]. Chin Evid Based Nurs, 2019, 5(8):730-733.
[13] 檀旭红. 深圳某三级医院护士科研伦理认知水平调查及影响因素[J]. 临床护理杂志, 2021, 20(6):67-70.
  Tan XH. Investigation on the cognitive level of nurses’ scientific research ethics in a tertiary hospital in Shenzhen and its influencing factors[J]. J Clin Nurs, 2021, 20(6):67-70.
[14] 唐喻莹, 叶菁舟, 何梅. 临床护理人员科研伦理认知及培训需求调查[J]. 护理学杂志, 2021, 36(1):60-62.
  Tang YY, Ye JZ, He M. Cognition and training demand of scientific research ethics among clinical nurses[J]. J Nurs Sci, 2021, 36(1):60-62.
[15] 尚少梅, 吴雪, 高艳红, 等. 22个省市三级医院护士科研能力与培训需求的现状调查[J]. 中华护理杂志, 2018, 53(3):277-280.
  Shang SM, Wu X, Gao YH, et al. Investigation of nurses’ scientific research competency and training demand in Chinese tertiary hospitals[J]. Chin J Nurs, 2018, 53(3):277-280.
[16] 杨丰华, 贺瑞蕊, 任红艳, 等. 人口社会学特征对临床研究型护士批判性思维的影响研究[J]. 中华现代护理杂志, 2022, 28(21):2907-2910.
  Yang FH, He RR, Ren HY, et al. Effect of demographic sociological data on critical thinking of clinical research nurses[J]. Chin J Mod Nurs, 2022, 28(21):2907-2910.
[17] 曹娟, 仲艳, 陈光明, 等. 我国护理人员护理科研伦理认知分析及提升策略研究[J]. 中国医学伦理学, 2022, 35(11):1218-1223.
  Cao J, Zhong Y, Chen GM, et al. Cognitive analysis and improvement strategy of nursing staff’s nursing research ethics in China[J]. Chin Med Ethics, 2022, 35(11):1218-1223.
Options
文章导航

/

〈 〉