新型冠状病毒肺炎（COVID-19）研究性疗法临床试验中的知情同意问题：脆弱性与自愿性
Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness.
作者信息
Bhatt Arun
机构信息
Consultant - Clinical Research and Drug Development, Mumbai, Maharashtra, India.
出版信息
Perspect Clin Res. 2020 Oct-Dec;11(4):174-177. doi: 10.4103/picr.PICR_271_20. Epub 2020 Oct 6.
Abstract
Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations - voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investigator, and the ethics committee - are discussed briefly.
摘要
从参与新型冠状病毒肺炎（COVID-19）研究性治疗临床试验的弱势患者那里获得知情同意是一项重大的伦理挑战。本文简要讨论了伦理和操作方面的考量——自愿性、豁免、时机、时间、文件记录以及申办者、研究者和伦理委员会的责任。
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