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Abstract：
Global fatalities related to COVID-19 are expected to be high in 2020-2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods-that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made.
摘要：
预计2020-2021年与COVID-19相关的全球死亡人数将很高。开发和提供疫苗可能是结束大流行的最有可能的方法。如果有可能将此开发时间缩短数周或数月，这可能对减少死亡有重大影响.如果使用人类挑战方法，II期和III期试验的时间可能不会那么长，也就是说，接种后故意感染COVID-19的参与者。本文分析了支持和反对这种方法的论点，并为监管机构提供了建议的广泛指导方针，研究人员和伦理委员会在考虑这些问题时。结论是，在延迟至关重要的情况下，可以维持当前的道德标准，但仍然允许进行人体挑战试验。其含义是，监管机构和研究人员现在需要共同努力，设计健壮但简短的试验，并简化伦理批准程序，以便在提出试验申请时到位。
