Monash Bioethics Centre and WHO Collaborating Centre for Bioethics, Monash University, Melbourne, VIC, Australia; Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.
Monash Bioethics Centre and WHO Collaborating Centre for Bioethics, Monash University, Melbourne, VIC, Australia.
Lancet Infect Dis. 2020 Aug;20(8):e198-e203. doi: 10.1016/S1473-3099(20)30438-2. Epub 2020 May 29.
COVID-19 poses an extraordinary threat to global public health and an effective vaccine could provide a key means of overcoming this crisis. Human challenge studies involve the intentional infection of research participants and can accelerate or improve vaccine development by rapidly providing estimates of vaccine safety and efficacy. Human challenge studies of low virulence coronaviruses have been done in the past and human challenge studies with severe acute respiratory syndrome coronavirus 2 have been proposed. These studies of coronaviruses could provide considerable benefits to public health; for instance, by improving and accelerating vaccine development. However, human challenge studies of severe acute respiratory syndrome coronavirus 2 in particular might be controversial, in part, for ethical reasons. The ethical issues raised by such studies thus warrant early consideration involving, for example, broad consultation with the community. This Personal View provides preliminary analyses of relevant ethical considerations regarding human challenge studies of severe acute respiratory syndrome coronavirus 2, including the potential benefits to public health and to participants, the risks and uncertainty for participants, and the third-party risks (ie, to research staff and the wider community). We argue that these human challenge studies can reasonably be considered ethically acceptable insofar as such studies are accepted internationally and by the communities in which they are done, can realistically be expected to accelerate or improve vaccine development, have considerable potential to directly benefit participants, are designed to limit and minimise risks to participants, and are done with strict infection control measures to limit and reduce third-party risks.
COVID-19 对全球公共卫生构成了特殊威胁，有效的疫苗可能是克服这一危机的关键手段。人体挑战研究涉及对研究参与者的故意感染，可以通过快速提供疫苗安全性和有效性的估计，加速或改进疫苗的开发。过去已经进行了低毒力冠状病毒的人体挑战研究，并且已经提出了严重急性呼吸综合征冠状病毒 2 的人体挑战研究。这些冠状病毒的研究可能会对公共卫生带来巨大的益处，例如，通过改进和加速疫苗的开发。然而，特别是严重急性呼吸综合征冠状病毒 2 的人体挑战研究可能会引起争议，部分原因是出于伦理原因。因此，此类研究引发的伦理问题需要及早考虑，例如，与社区进行广泛的协商。本个人观点对严重急性呼吸综合征冠状病毒 2 的人体挑战研究的相关伦理问题进行了初步分析，包括对公共卫生和参与者的潜在益处、对参与者的风险和不确定性以及第三方风险（即研究人员和更广泛的社区）。我们认为，只要这些人体挑战研究在国际上和进行研究的社区得到接受，并且可以合理地预期加速或改进疫苗的开发，就可以直接使参与者受益，设计旨在限制和最小化参与者的风险，并采取严格的感染控制措施来限制和降低第三方风险，这些研究在伦理上是可以接受的。
