Centre for Biomedical Ethics, National University of Singapore, Yong Loo Lin School of Medicine, Block MD11, Clinical Research Centre, #02-03, 10 Medical Drive, Singapore 117597, Singapore.
Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building (MD1), 12 Science Drive 2, Singapore 117549, Singapore.
Vaccine. 2020 Jul 14;38(33):5085-5088. doi: 10.1016/j.vaccine.2020.06.007. Epub 2020 Jun 4.
While a human challenge study holds the prospect of accelerating the development of a vaccine for the coronavirus SARS-CoV-2, it may be opposed due to risks of harm to participants and researchers. Given the increasing number of human deaths and severe disruption to lives worldwide, we argue that a SARS-CoV-2 challenge study is ethically justifiable as its social value substantially outweighs the risks. Such a study should therefore be seriously considered as part of the global research response towards the COVID-19 pandemic. In this paper, we contribute to the debate by addressing the misperception that a challenge study for the coronavirus would lower scientific and ethical standards for vaccine research and development, and examine how it could be ethically conducted. We also set out information that needs to be disclosed to prospective participants to obtain their consent.
虽然人类挑战研究有望加速冠状病毒 SARS-CoV-2 的疫苗开发，但由于参与者和研究人员面临的风险，该研究可能会遭到反对。鉴于全球范围内死亡人数不断增加和生活受到严重干扰，我们认为 SARS-CoV-2 挑战研究在伦理上是合理的，因为其社会价值大大超过了风险。因此，应该认真考虑将此类研究作为应对 COVID-19 大流行的全球研究应对措施的一部分。在本文中，我们通过解决人们对冠状病毒挑战研究将降低疫苗研究和开发的科学和伦理标准的误解来为这场辩论做出贡献，并探讨如何在伦理上进行这项研究。我们还列出了需要向潜在参与者披露以获得其同意的信息。
