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在疫情爆发背景下开展临床研究的伦理道德。

Ethics of Conducting Clinical Research in an Outbreak Setting.

机构信息

Division of Pediatric Infectious Diseases, Vanderbilt University School of Medicine, Nashville, Tennessee 37232, USA; email:

Global Healthcare Consulting, New Delhi 110024, India.

出版信息

Annu Rev Virol. 2020 Sep 29;7(1):475-494. doi: 10.1146/annurev-virology-013120-013123. Epub 2020 Mar 25.

DOI:10.1146/annurev-virology-013120-013123
PMID:32212920
Abstract

The conduct of clinical trials during the West Africa Ebola outbreak in 2014 highlighted many ethical challenges. How these challenges were addressed, what clinical studies were conducted during that outbreak, and the lessons learned for dealing with future outbreaks were the subject of a National Academy of Medicine committee report titled . This report suggested improvements for research during subsequent emerging or re-emerging outbreaks and is summarized in this review. We also discuss the current Ebola outbreak in the Democratic Republic of the Congo and highlight how the dialogue has changed and how successful clinical trials have been implemented. We conclude with a description of productive efforts to include pregnant women and children in therapeutic and vaccine trials during outbreaks that are currently ongoing.

摘要

2014 年西非埃博拉疫情期间的临床试验实施工作凸显了诸多伦理挑战。美国国家医学院(National Academy of Medicine)的一个委员会曾就这些挑战的应对方式、疫情期间开展的临床研究,以及为应对未来疫情而总结的经验教训进行了探讨,并发表了一份题为《应对突发公共卫生事件的研究伦理:保护参与研究的个体》的报告。该报告针对后续新发或再发传染病疫情期间的研究提出了改进建议,本文对其进行了总结。本文还讨论了刚果民主共和国目前的埃博拉疫情,并重点介绍了相关对话的变化情况,以及成功实施临床试验的经验。本文最后描述了在目前正在进行的疫情中,为将孕妇和儿童纳入治疗和疫苗试验所做出的积极努力。