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本文引用的文献

1
Decentralized clinical trials (DCTs): A few ethical considerations.去中心化临床试验(DCTs):几点伦理考虑。
Front Public Health. 2022 Dec 15;10:1081150. doi: 10.3389/fpubh.2022.1081150. eCollection 2022.
2
Development and Pilot of a REDCap Electronic Informed Consent Form for Research: An Example from the ROPE Study.用于研究的 REDCap 电子知情同意书的开发与试点:以 ROPE 研究为例
J Inform Nurs. 2021;6(3):1-8.
3
A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs).关于去中心化临床试验(DCTs)中参与者招募、保留和依从性的利益相关者观点的二次定性分析。
Trials. 2022 Jul 30;23(1):614. doi: 10.1186/s13063-022-06521-4.
4
E-Consent-a guide to maintain recruitment in clinical trials during the COVID-19 pandemic.E-Consent:在 COVID-19 大流行期间维持临床试验招募的指南。
Trials. 2022 May 12;23(1):388. doi: 10.1186/s13063-022-06333-6.
5
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective.去中心化临床试验的机遇与挑战:欧洲监管机构视角。
Clin Pharmacol Ther. 2022 Aug;112(2):344-352. doi: 10.1002/cpt.2628. Epub 2022 May 17.
6
Personalized and long-term electronic informed consent in clinical research: stakeholder views.临床研究中的个性化和长期电子知情同意:利益相关者的观点。
BMC Med Ethics. 2021 Jul 31;22(1):108. doi: 10.1186/s12910-021-00675-7.
7
Platform Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE): protocol for a randomised, controlled, open-label, adaptive platform, trial of community treatment of COVID-19 syndromic illness in people at higher risk.针对老年人的 COVID-19 干预措施的平台随机试验(PRINCIPLE):一项针对 COVID-19 综合征疾病在高风险人群中进行社区治疗的随机、对照、开放标签、适应性平台试验的方案。
BMJ Open. 2021 Jun 18;11(6):e046799. doi: 10.1136/bmjopen-2020-046799.
8
The TOPAZ study: a home-based trial of zoledronic acid to prevent fractures in neurodegenerative parkinsonism.TOPAZ研究:一项在家中进行的唑来膦酸预防神经退行性帕金森病骨折的试验。
NPJ Parkinsons Dis. 2021 Mar 1;7(1):16. doi: 10.1038/s41531-021-00162-1.
9
Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting.远程开展研究的电子知情同意:当前实践的回顾及使用电子知情同意的关键建议
Int J Med Inform. 2020 Nov;143:104271. doi: 10.1016/j.ijmedinf.2020.104271. Epub 2020 Sep 13.
10
Evaluating the Perceptions of Teleconsent in Urban and Rural Communities.评估城乡社区对远程同意的看法。
Eur J Biomed Inform (Praha). 2019 Aug;15(2). Epub 2019 Jul 5.

探讨临床试验中电子知情同意伦理问题。

Towards an understanding of the ethics of electronic consent in clinical trials.

机构信息

Ethox Centre, Oxford Population Health, University of Oxford, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.

Clinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.

出版信息

Trials. 2024 Aug 16;25(1):545. doi: 10.1186/s13063-024-08330-3.

DOI:10.1186/s13063-024-08330-3
PMID:39152507
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11329992/
Abstract

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

摘要

使用电子知情同意(e-consent)在随机试验中具有良好的实际意义,特别是在进行大规模临床试验以回答人群健康研究问题时。然而,确定使用电子知情同意的伦理理由并不那么明确,并且取决于对在临床试验中使用的电子知情同意的含义及其伦理意义的正确理解。在这里,我们重点关注具有伦理意义的四个特征,这些特征引发了与电子知情同意相关的一系列伦理考虑因素,值得进一步进行重点伦理学研究。