The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic.
The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic.
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DOI：
10.1002/eahr.500083
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发表时间：
2021-03-01
影响因子：
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通讯作者：
Hull, Sara Chandros
中科院分区：
文献类型：
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作者：
Berkman, Benjamin E;Mastroianni, Anna C;Hull, Sara Chandros
在大流行的早期，改变现有研究项目中的生物检疫试剂的用途可能被证明在实现重大和及时的公共卫生利益方面非常有用。尽管如此，潜在的伦理和监管不确定性可能会阻碍这些有价值的生物标本的获取。在这篇文章中，我们认为，如果满足某些条件，应推定使用先前收集的可识别的研究生物标本直接应对传染病大流行，而无需重新同意。这一论点填补了决策中的一个独特但关键的空白，即可识别生物样品附带的具体同意否则不允许改变用途。此外，它还表明，即使获得重新同意是可行的，但在一场快速发展的危机中这样做是没有必要的。这项分析还试图解决公共卫生当局的伦理关切，他们可能已经有权使用这种标本，但不愿这样做。
In the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision-making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast-moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.