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涉及住院患者的研究中的伦理挑战:一项现象学研究。

Ethical Challenges in Research Involving Hospitalized Patients: A Phenomenological Study.

作者信息

Rony Moustaq Karim Khan, Akther Dilruba, Peu Umme Rabeya, Alam Md Shafiul, Shaleah Abu Zafor Md, Alam Md Zahirul, Parvin Mst Rina, Kayesh Ibne, Madhu Sandra Rumi, Alrazeeni Daifallah M, Akter Fazila

机构信息

Miyan Research Institute, International University of Business Agriculture and Technology, Dhaka, Bangladesh.

Shahjalal University of Science and Technology, Sylhet, Bangladesh.

出版信息

Health Care Anal. 2025 Jul 10. doi: 10.1007/s10728-025-00534-1.

DOI:10.1007/s10728-025-00534-1
PMID:40638035
Abstract

Hospital-based research plays a crucial role in advancing medical knowledge, but it also presents significant ethical challenges, particularly when involving hospitalized patients. Ethical concerns such as informed consent, patient autonomy, and the power dynamics between healthcare providers and patients are critical to maintaining the integrity of such research. The aim of this research was to explore and analyze the ethical considerations in conducting research involving hospitalized patients. A qualitative phenomenological approach was used to investigate the experiences and perceptions of healthcare professionals involved in clinical or public health research in hospital settings. Semi-structured interviews were conducted with 33 participants from both public and private hospitals in Dhaka, Bangladesh. The data were analyzed using thematic analysis to identify recurring ethical themes. This study identified five key themes: (1) Ethical challenges in hospital-based research, (2) Informed consent and patient vulnerability, (3) Patient autonomy and decision-making in research, (4) Institutional Review Boards (IRBs) and ethical oversight, and (5) Strategies to improve ethical research practices in hospitals. Participants reported concerns about coercion, difficulties in obtaining consent from critically ill patients, conflicts in surrogate decision-making, and delays in IRB approval. The findings also emphasized the importance of ethical training, continuous consent practices, and patient-centered approaches. Ethical research practices in hospital settings require a balance between scientific progress and patient protection. The study emphasizes the need for improved ethical guidelines, better informed consent processes, and ongoing training for healthcare professionals to ensure patient autonomy is respected. The findings also call for streamlined Institutional Review Board (IRB) processes to support timely and ethical research execution.

摘要

基于医院的研究在推进医学知识方面发挥着关键作用,但它也带来了重大的伦理挑战,尤其是在涉及住院患者时。诸如知情同意、患者自主权以及医疗服务提供者与患者之间的权力动态等伦理问题对于维持此类研究的完整性至关重要。本研究的目的是探讨和分析在开展涉及住院患者的研究时的伦理考量。采用定性现象学方法来调查参与医院环境中临床或公共卫生研究的医疗专业人员的经历和看法。对来自孟加拉国达卡公立和私立医院的33名参与者进行了半结构化访谈。使用主题分析法对数据进行分析,以确定反复出现的伦理主题。本研究确定了五个关键主题:(1)基于医院的研究中的伦理挑战,(2)知情同意与患者脆弱性,(3)研究中的患者自主权与决策,(4)机构审查委员会(IRB)与伦理监督,以及(5)改善医院伦理研究实践的策略。参与者报告了对胁迫的担忧、从重症患者处获得同意的困难、替代决策中的冲突以及IRB批准的延迟。研究结果还强调了伦理培训、持续同意实践以及以患者为中心方法的重要性。医院环境中的伦理研究实践需要在科学进步与患者保护之间取得平衡。该研究强调需要改进伦理准则、完善知情同意程序,并为医疗专业人员提供持续培训,以确保患者自主权得到尊重。研究结果还呼吁简化机构审查委员会(IRB)程序,以支持及时且符合伦理的研究执行。

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本文引用的文献

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Exploring ethical considerations in medical research: Harnessing pre-generated transformers for AI-powered ethics discussions.探索医学研究中的伦理考量:利用预生成的变压器进行人工智能驱动的伦理讨论。
PLoS One. 2025 Feb 3;20(2):e0311148. doi: 10.1371/journal.pone.0311148. eCollection 2025.
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Revisions to the Declaration of Helsinki on Its 60th Anniversary: A Modernized Set of Ethical Principles to Promote and Ensure Respect for Participants in a Rapidly Innovating Medical Research Ecosystem.
《赫尔辛基宣言》60周年修订版:一套现代化的伦理原则,以促进和确保在快速创新的医学研究生态系统中尊重参与者。
JAMA. 2025 Jan 7;333(1):15-17. doi: 10.1001/jama.2024.21902.
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Ethical Considerations and Equipoise in Cancer Surgery.癌症手术中的伦理考量与 equipoise(此处equipoise 可能是专业术语,暂保留英文,未查到确切对应中文释义)
Indian J Surg Oncol. 2024 Sep;15(Suppl 3):363-373. doi: 10.1007/s13193-024-02023-8. Epub 2024 Jul 12.
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Ethical and Legal Challenges in Caring for Older Adults with Multimorbidities: Best Practices for Nurses.照顾患有多种疾病的老年人时面临的伦理和法律挑战:护士的最佳实践
Healthcare (Basel). 2024 Aug 9;12(16):1585. doi: 10.3390/healthcare12161585.
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Patient informed consent, ethical and legal considerations in the context of digital vulnerability with smart, cardiac implantable electronic devices.患者知情同意、智能心脏植入式电子设备数字脆弱性背景下的伦理与法律考量
PLOS Digit Health. 2024 May 23;3(5):e0000507. doi: 10.1371/journal.pdig.0000507. eCollection 2024 May.
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J Multidiscip Healthc. 2024 Apr 12;17:1619-1627. doi: 10.2147/JMDH.S455910. eCollection 2024.
8
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J R Coll Physicians Edinb. 2024 Jun;54(2):153-158. doi: 10.1177/14782715241247087. Epub 2024 Apr 14.
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