Self-experimentation, ethics, and regulation of vaccines.
Self-experimentation, ethics, and regulation of vaccines.
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DOI：
10.1126/science.abe1963
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发表时间：
2020-09-25
期刊：
影响因子：
--
通讯作者：
Zettler PJ
中科院分区：
文献类型：
--
作者：
Guerrini CJ;Sherkow JS;Meyer MN;Zettler PJ
随着冠状病毒病2019(新冠肺炎)大流行继续席卷全球，几个组织一直在努力开发和自我管理未经批准、未经证实的干预措施，他们称这些干预措施是新冠肺炎(1-4)的疫苗。对这些DIY方法的兴趣显然源于这样一种信念，即自我实验永远不会受到耗时的道德委员会的审查或监管，例如美国食品和药物管理局(FDA)的审查或监管。这种想法在法律上和事实上都是不正确的，这种误解可能会对公共卫生产生重要影响。FDA未能对DIY疫苗进行监管，将允许安全性和有效性可疑的疫苗危害公众健康，并标志着标准的降低--在一个饱受疫苗怀疑论困扰的时代，在高度政治化的大流行期间--可能会破坏公众对所有疫苗的信任，无论如何开发[5]。此外，根据法律或机构政策的规定，一些自我实验可以被认为是需要接受伦理审查的人体研究对象。即使在不需要伦理审查的情况下，公民科学家在推广DIY干预措施时也必须认真履行他们高度的伦理责任，特别是那些可能会对公共健康和社会产生严重影响的干预措施，如新冠肺炎疫苗。鉴于反对新冠肺炎的公民科学努力的激增，以及围绕DIY研究监管的普遍困惑(即使是在经验丰富的科学家中间)，迫切需要监管领导。
As the coronavirus disease 2019 (COVID-19) pandemic continues to sweep the globe, several groups have been working to develop and self-administer unapproved, unproven interventions that they describe as vaccines for COVID-19 (1–4). Some of the interest in these do-it-yourself (DIY) approaches apparently stems from a belief that self-experimentation is never subject to time-consuming ethics board review or regulation, such as by the U.S. Food and Drug Administration (FDA). This belief is legally and factually incorrect, and the misunderstanding has potentially important public health implications. Any failure by the FDA to regulate DIY vaccines would permit vaccines of dubious safety and effectiveness to endanger public health and would signal a lowering of standards that—in an age blighted by vaccine skepticism and during a highly politicized pandemic—could undermine public trust in all vaccines, however developed (5). Further, some self-experimentation can qualify as human subjects research that is required to undergo ethics review, by law or institutional policy. Even when ethics review is not required, citizen scientists must take seriously their heightened ethical responsibilities when promoting DIY interventions, especially those with potentially serious public health and societal effects, such as COVID-19 vaccines. Given the proliferation of citizen science efforts to fight COVID-19 and the general confusion (even among sophisticated scientists) that surrounds the regulation of DIY research, regulatory leadership is badly needed.
影响因子：
2.1
作者：
Meyer, Michelle N.
通讯作者：
Meyer, Michelle N.