RAPID: Responsible conduct of accelerated SARS-CoV-2 vaccine research through challenge trials

该项目审查了通过人体挑战试验加速研究COVID-19疫苗的伦理问题。在人体挑战试验中，健康志愿者在接种疫苗（或安慰剂）后故意暴露于病毒。该项目考察了这些试验的伦理性，以及如何通过哲学研究和对挑战试验志愿者的调查使其更具伦理性。虽然即使是最符合道德规范的挑战试验也会给志愿者带来风险，但这些试验也可以将COVID-19疫苗的开发速度加快几个月。鉴于目前的感染率和死亡率，这一时间的增加可以转化为成千上万人的生命得到拯救。在未来需要快速测试疫苗效力的公共卫生危机中，研究结果也将使人类受益。研究结果的传播将促进公众的科学素养，并加深对STEM学科的科学、伦理和技术的参与。澄清这些伦理原则将促进政府、学术界、工业界和其他方面之间更有效的伙伴关系，并通过增强对流行病、生物战和其他威胁的抵御能力来促进国家安全。该项目采用多种方法调查COVID-19人体挑战试验的伦理问题。它有三个主要的研究组成部分：1)对是否有可能以负责任的方式进行SARS-CoV-2挑战试验进行哲学审查，根据什么标准（例如，什么样的纳入和排除标准和试验程序将减少对参与者的净伤害），以及受什么样的机构监督机制（例如，特别增加的内部审查委员会/专家工作组）；2)对3000名积极参与SARS-Cov-2人体挑战试验的志愿者和随机选择的对照组进行调查，了解他们对COVID-19和当前大流行的动机和信念、风险认知和承担风险的意愿；3)根据研究结果为试用者创建教育包。该方案将教育试验人员了解挑战试验的潜在陷阱，例如对试验细节和风险的潜在误解，知情同意程序必须强调这一点，并避免不公平的参与者选择，鉴于许多高传播/高峰地区的社会经济地位较低，这可能是一个陷阱。该项目推进了STEM研究伦理的几个领域的知识，包括挑战研究的伦理，参与者的风险和收益评估，以及参与者自主授权研究的程度，甚至可能使一些不利的风险/收益比在伦理上可以容忍。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

This project examines the ethics of accelerating research into a COVID-19 vaccine through human challenge trials. In a human challenge trial, healthy volunteers are deliberately exposed to the virus after being given the vaccine (or placebo). The project examines the ethics of these trials and how to make them more ethical through philosophical research and through a survey of challenge trial volunteers. While even the most ethically conducted challenge trial will involve risks to volunteers, these trials can also accelerate the development of a vaccine for COVID-19 by several months. Given the current rates of infection and mortality, this time gain could translate into many thousands of lives being saved. Findings will also benefit humanity in future public health crises where quick testing of vaccine efficacy is needed. Dissemination of the findings will promote public scientific literacy, and deepened engagement with science, ethics, and technology across STEM disciplines. Clarifying these ethical principles will facilitate more efficient partnerships between government, academia, industry, and others, and promote national security via increased resilience to pandemics, biological warfare, and other threats. This project uses multiple methods to investigate the ethics of human challenge trials for COVID-19. It has three main research components: 1) a philosophical examination of whether responsible conduct of challenge trials for SARS-CoV-2 is possible, under what criteria (e.g., what inclusion and exclusion criteria and trial procedures would reduce net harm to participants), and subject to what institutional oversight mechanisms (e.g., a special added IRB/expert taskforce); 2) a survey of 3,000 proactive volunteers for SARS-Cov-2 human challenge trials and a randomly selected control group about their motivations and beliefs about COVID-19 and the current pandemic, risk perceptions, and willingness to take risks; and 3) creation of an education package for trialists based on the findings. This package will educate trialists about potential pitfalls of challenge trials, such as potential misunderstanding of trial details and risk, which the informed consent process must emphasize, and avoiding unfair participant selection, which might be a pitfall given the lower socio-economic status of many high-transmission/surge areas. This project advances knowledge in several areas of STEM research ethics, including the ethics of challenge studies, the assessment of risks and benefits to participants, and the degree to which participants’ autonomous authorization of research may make even somewhat adverse risk/benefit ratios ethically tolerable.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.