In December 2014, five months after the initial surge in public interest surrounding the Ebola virus outbreak of that year, PRIM&R held a special session at the 2014 Advancing Ethical Research Conference (AER14) on the ethical considerations crucial to the evaluation of treatments and vaccines in viral outbreaks. As of today, we are a mere five weeks out from the world learning about the novel coronavirus (COVID-19) outbreak that originated this winter in Wuhan, China.
PRIM&R’s AER14 session on the “Scientific, Regulatory, and Ethical Issues with Experimental Treatments and Ebola Vaccines” was recorded, and is freely available for you to view below.
The session brought together panelists from the US and Nigerian federal governments, industry, and academia to discuss the dramatic challenges to doing ethical research in the context of an outbreak. One issue in the Ebola outbreak was the degree to which the principle of equipoise had been met: was there genuine uncertainty about whether the experimental treatment was better, when the “gold standard” to which it would be compared was so ineffective? And in the absence of equipoise, it was unclear whether the research and medical communities could or would be able to build sufficient trust in the affected communities to conduct ethical research.
Trial design was also a major concern of the panelists, and a particular focus was the worry that hasty or insufficiently powered designs would not only fail to improve the health of impacted communities, but might in fact cause added harm.
The urgency and fear that surround a viral outbreak like Ebola or coronavirus bring into sharp focus the ethical risks of doing research in such contexts. Adding to the urgency of these considerations is that these ethical concerns can be magnified in cases, like Ebola and coronavirus, where international political and social relationships shape our understanding of both the diseases and those affected by them. More than 100 research trials are reported to be underway on coronavirus already, and it remains essential to lean on prior conversations and learning to put us in a position to conduct the best, most ethical research we can in a time of crisis.
Tim Badmington is the Public Engagement Manager at PRIM&R.