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伦理原则的扩展及其在 COVID-19 疫苗试验中的实施:基于证据的研究综合概述。

Expanded principles of ethics and its implementation during COVID-19 vaccine trials: A scoping evidence based research synthesis.

机构信息

Department of Public Health Dentistry, TPCT'S Terna Dental College, Navi Mumbai, Maharashtra, India.

TPCT's Terna Dental College, Navi Mumbai, Maharashtra, India.

出版信息

Hum Vaccin Immunother. 2021 Nov 2;17(11):3843-3849. doi: 10.1080/21645515.2021.1947101. Epub 2021 Jul 15.

DOI:10.1080/21645515.2021.1947101
PMID:34264174
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8827634/
Abstract

The COVID-19 pandemic will subside only through the emergence and distribution of an efficacious vaccine. The two main aspects that should be maintained in equilibrium: the dire necessity for speedy vaccine research and the need for safeguarding the research subjects, which is of utmost concern in research ethics. This opens up a discussion of what norms to follow during the clinical trials while developing the vaccine. As of now, various companies like Moderna, Pfizer, University of Oxford, Astra-Zeneca and so on have moved beyond the safety, efficacy and immunogenic studies. This narrative review explores and discusses the key principles of ethics: a principle of autonomy, beneficence, non-maleficence, and justice along with its ten general expanded principles. Furthermore, it delves into the different types of vaccines, their mechanisms, side effects, limitations, and advantages.

摘要

只有出现并分发有效的疫苗,COVID-19 大流行才会消退。应该保持平衡的两个主要方面:快速疫苗研究的迫切需要和保护研究对象的需要,这是研究伦理中最令人关注的问题。这就引出了一个讨论,即在开发疫苗的临床试验中应遵循哪些规范。到目前为止,莫德纳、辉瑞、牛津大学、阿斯利康等各种公司已经超越了安全性、有效性和免疫原性研究。本叙述性评论探讨和讨论了伦理学的关键原则:自主性原则、善行原则、不伤害原则和正义原则,以及其十个扩展的一般原则。此外,还深入探讨了不同类型的疫苗、它们的机制、副作用、局限性和优势。

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本文引用的文献

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Lancet Healthy Longev. 2020 Oct;1(1):e6-e8. doi: 10.1016/S2666-7568(20)30003-9. Epub 2020 Oct 20.
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Emergency use authorisation of Covid-19 vaccines: An ethical conundrum.Covid-19 疫苗的紧急使用授权:一个伦理难题。
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Covid-19: India is at centre of global vaccine manufacturing, but opacity threatens public trust.新冠疫情:印度是全球疫苗生产的中心,但透明度问题正威胁公众信任。
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Global equitable access to vaccines, medicines and diagnostics for COVID-19: The role of patents as private governance.全球公平获取用于应对新冠疫情的疫苗、药品和诊断工具:专利作为私人治理手段的作用。
J Med Ethics. 2020 Nov 30. doi: 10.1136/medethics-2020-106795.
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The Advisory Committee on Immunization Practices' Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020.免疫实践咨询委员会分配 COVID-19 疫苗初始供应的道德原则-美国,2020 年。
MMWR Morb Mortal Wkly Rep. 2020 Nov 27;69(47):1782-1786. doi: 10.15585/mmwr.mm6947e3.
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Int J Clin Pract. 2021 Mar;75(3):e13795. doi: 10.1111/ijcp.13795. Epub 2020 Dec 4.
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