Ethical Pathways for Therapeutics and Vaccine R&D in the Context of Public Health Emergencies of International Concern: An Analysis of the 2013-16 Ebola Outbreak to Rapidly Inform COVID-19 R&D

A cross-cutting research priority identified by the recent WHO COVID-19 Global Research and Innovation Forum is the establishment of appropriate ethical oversight and global collaboration to accelerate COVID-19 R&D, and to establish these in such a way that promotes solidarity and equity. Yet, the existing COVID-19 research roadmap and WHO R&D Blueprint are largely silent on the global ethical pathways required to guide and oversee rapid therapeutics and vaccine R&D in this context (including whether and how such pathways ought to be modified, or precisely what solidarity and equity require for these activities). To identify and successfully navigate these ethical and regulatory pathways for COVID-19 R&D, we can look to the unprecedented R&D response to the 2013-16 Ebola virus disease (EVD) outbreak for guidance. Only five months following the development of the first study protocols for EVD, the first patients were enrolled in clinical trials. Only four years later, the first vaccine was licensed in the United States. The atypical expediency of these R&D efforts was, in part, a product of significant modifications and adaptations to the usual ethical and regulatory pathways for health product development-pathways that involve ethical inputs into study protocols, independent ethics review of studies, global consultation and governance, data sharing agreements, and the approval, licensure, and dissemination of resulting products. This project will for the first time (1) analyze and describe the ethical pathways for R&D that existed or were established for EVD in order to aid the global research community in navigating these pathways for COVID-19 R&D; (2) analyze and describe the ethical pathways as they are established and navigated for COVID-19 R&D in order to rapidly support ongoing and future COVID-19 R&D; and (3) compare and conduct an ethical analysis of the ethical pathways for EVD and COVID-19 R&D to inform future R&D during epidemics.