DIY COVID-19 vaccines raise legal and ethical questions 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.

中文翻译：

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疫苗的自我实验、伦理和监管

DIY COVID-19 疫苗引发法律和伦理问题随着 2019 年冠状病毒病 (COVID-19) 大流行继续席卷全球，多个团体一直在努力开发和自行实施未经批准、未经证实的干预措施，他们将其描述为 COVID-19 疫苗 - 19（1-4）。人们对这些自己动手 (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。这种看法在法律上和事实上都是错误的，而且这种误解具有潜在的重要公共卫生影响。FDA 对 DIY 疫苗监管的任何失败都将导致安全性和有效性存疑的疫苗危及公众健康，并意味着标准的降低——在疫苗怀疑论盛行的时代和高度政治化的大流行期间——可能会损害公众对所有疫苗的信任。无论疫苗如何开发（5）。此外，一些自我实验可以被视为人类受试者研究，需要根据法律或机构政策进行伦理审查。即使不需要伦理审查，公民科学家在推广 DIY 干预措施时也必须认真对待其更高的道德责任，特别是那些具有潜在严重公共卫生和社会影响的干预措施，例如 COVID-19 疫苗。鉴于对抗 COVID-19 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），迫切需要监管领导力。