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

RAPID：通过挑战试验负责任地加速 SARS-CoV-2 疫苗研究

• 批准号: 2039320
• 负责人: Nir Eyal
• 金额: $ 20万
• 依托单位: Rutgers University New Brunswick
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2039320&HistoricalAwards=false
• 关键词: RAPID; Responsible; conduct; accelerated; SARS

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.

该项目探讨了通过人体挑战试验加速COVID-19疫苗研究的伦理问题。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。该项目研究这些试验的伦理问题，以及如何通过哲学研究和对挑战性试验志愿者的调查使其更具伦理性。虽然即使是最符合伦理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。考虑到目前的感染率和死亡率，这一时间上的节省可以转化为拯救成千上万的生命。这些发现也将使人类在未来的公共卫生危机中受益，因为在这些危机中需要快速测试疫苗的有效性。研究结果的传播将促进公众的科学素养，并加深与科学，伦理和技术跨STEM学科的接触。澄清这些道德原则将有助于政府、学术界、工业界和其他方面建立更有效的伙伴关系，并通过提高对流行病、生物战和其他威胁的抵御能力来促进国家安全。该项目使用多种方法调查COVID-19人体挑战试验的伦理学。它有三个主要的研究组成部分：1）对SARS-CoV-2挑战试验的负责任行为是否可能，在什么标准下（例如，什么样的入选和排除标准以及试验程序会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，一个特别增加的IRB/专家工作组）; 2）对3,000名SARS-Cov-2人体挑战试验的主动志愿者和一个随机选择的对照组进行调查，了解他们对COVID-19和当前流行病的动机和信念、风险认知和冒险意愿;以及3）根据调查结果为试验人员创建一个教育包。这套资料将使试验者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/激增地区的社会经济地位较低，这可能是一个陷阱。该项目在STEM研究伦理的几个领域推进知识，包括挑战研究的伦理，对参与者的风险和利益的评估，以及参与者自主授权研究的程度，甚至可能造成某种程度的不利风险/该奖项反映了NSF的法定使命，并通过使用基金会的智力价值进行评估，更广泛的影响审查标准。

项目成果

Reply to Hasford and to Spinola et al.

回复哈斯福德和斯皮诺拉等人。

• DOI: 10.1093/infdis/jiaa458
• 发表时间: 2020
• 期刊: The Journal of infectious diseases
• 作者: Eyal,Nir;Lipsitch,Marc;Smith,PeterG
• 通讯作者: Smith,PeterG

Study bystanders and ethical treatment of study participants-A proof of concept.

研究旁观者和研究参与者的道德待遇——概念证明。

• DOI: 10.1111/bioe.12825
• 发表时间: 2020
• 期刊: Bioethics
• 影响因子: 2.2
• 作者: Eyal,Nir

Is There an Ethical Upper Limit on Risks to Study Participants?

研究参与者的风险是否有道德上限？

• DOI: 10.1093/phe/phaa028
• 发表时间: 2020
• 期刊: Public health ethics
• 影响因子: 2.1
• 作者: Eyal,Nir

SARS-CoV-2 Human Challenge Studies

SARS-CoV-2 人类挑战研究

• DOI: 10.1056/nejmc2113574
• 发表时间: 2021
• 期刊: New England Journal of Medicine
• 影响因子: 158.5

How to Test Severe Acute Respiratory Syndrome Coronavirus 2 Vaccines Ethically Even After One Is Available.

• DOI: 10.1093/cid/ciab182
• 发表时间: 2021-12-16
• 期刊: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
• 作者: Eyal N;Lipsitch M
• 通讯作者: Lipsitch M