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

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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.