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本文引用的文献

1
Modeling the Epidemic Trend of the 2019 Novel Coronavirus Outbreak in China.中国2019新型冠状病毒疫情流行趋势建模
Innovation (Camb). 2020 Nov 25;1(3):100048. doi: 10.1016/j.xinn.2020.100048. Epub 2020 Sep 28.
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[An urgent call for raising the scientific rigorousness of clinical trials on COVID-19].[关于提高新冠病毒肺炎临床试验科学严谨性的紧急呼吁]
Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Mar 10;41(3):301-302. doi: 10.3760/cma.j.issn.0254-6450.2020.03.004.
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Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding.新冠病毒的基因组特征和流行病学:对病毒起源和受体结合的影响。
Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.
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First Case of 2019 Novel Coronavirus in the United States.美国首例 2019 新型冠状病毒病例。
N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.
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The 2019-new coronavirus epidemic: Evidence for virus evolution.2019 新型冠状病毒疫情:病毒进化的证据。
J Med Virol. 2020 Apr;92(4):455-459. doi: 10.1002/jmv.25688. Epub 2020 Feb 7.
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Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China.中国武汉地区 2019 年新型冠状病毒感染患者的临床特征。
Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
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A novel coronavirus outbreak of global health concern.一场引发全球卫生关注的新型冠状病毒疫情。
Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24.
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A Novel Coronavirus from Patients with Pneumonia in China, 2019.2019 年中国肺炎患者中的一种新型冠状病毒。
N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
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Research Ethics Committees (RECs) and epidemic response in low and middle income countries.低收入和中等收入国家的研究伦理委员会与疫情应对
Pan Afr Med J. 2018 Nov 28;31:209. doi: 10.11604/pamj.2018.31.209.17076. eCollection 2018.
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Emergency care research ethics in low-income and middle-income countries.低收入和中等收入国家的急诊护理研究伦理
BMJ Glob Health. 2019 Jul 29;4(Suppl 6):e001260. doi: 10.1136/bmjgh-2018-001260. eCollection 2019.

开展 COVID-19 研究的伦理挑战与策略。

Challenges and strategies to research ethics in conducting COVID-19 research.

机构信息

Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, P.R. China.

出版信息

J Evid Based Med. 2020 May;13(2):173-177. doi: 10.1111/jebm.12388. Epub 2020 May 22.

DOI:10.1111/jebm.12388
PMID:32445288
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7280675/
Abstract

The number of research involving human subjects on coronavirus disease 2019 (COVID-19) is surging, bringing challenges to the ethical review committee (ERC) in terms of reviewing speed and special ethical considerations under the pandemic. However, the existing ethical review system and regulations have their limitations to meet the demand for a prompt and efficient epidemic control. Since the research under the public health emergency is different from that carried out in familiar situations to design and implementation, the strategy for a satisfactory ERC response should balance the duty of protecting individual participants as well as the special public needs derived from the disease control. It is suggested that the ethical review-related regulations need to be updated, and a unified supervision system to the overall ERC is required. ERC collaboration, capacity-improving and efficiency-improving measures need to be taken. With respect to the reviewing guidelines, it is suggested that the international norms should be explained with more consideration of the local condition and the exceptional circumstances in this public health emergency. A joint effort needs to be taken for better research conduction.

摘要

关于 2019 年冠状病毒病(COVID-19)的研究涉及人体受试者的数量正在迅速增加,这给伦理审查委员会(ERC)在大流行期间的审查速度和特殊伦理考虑方面带来了挑战。然而,现有的伦理审查制度和规定存在局限性,无法满足快速有效的疫情控制的需求。由于公共卫生紧急情况下的研究与在熟悉的情况下进行设计和实施的研究不同,因此令人满意的 ERC 应对策略应平衡保护个体参与者的责任以及从疾病控制中衍生出的特殊公共需求。建议更新与伦理审查相关的法规,并建立一个统一的监管体系来监督整个 ERC。需要采取 ERC 合作、提高能力和提高效率的措施。关于审查指南,建议在解释国际规范时,应更多地考虑当地情况和这种公共卫生紧急情况下的特殊情况。需要共同努力,以更好地开展研究。