Abstract

In his stimulating target article,1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’1, between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support. As Calain points out, although a tension between individual and public interests in clinical research always exists, this tension was heightened during the Ebola epidemic. Ebola had an average fatality rate of 40%–60% in this outbreak and reached up to 90% in some locations. Appropriate personal protective equipment was not always available; the level of benefit from supportive care was contested; and there were no targeted treatments and vaccines for the disease. Given this situation, patients with Ebola had a strong interest in accessing potential treatments even if they were unproven. This was especially true in the early phases of the epidemic when fatality rates were very high and seemingly safe ‘repurposed’ treatments were proposed for study. Individuals at high risk of contracting Ebola—for example, frontline workers or informal carers in the community—equally had a strong interest in accessing experimental vaccines, once their safety and ability to induce an immune response had been established in phase 1/2 testing. At the same time, the exponential spread of Ebola in the second half of 2014 created a strong public interest in rigorous research results that could support the rapid marketing authorization, mass production and widespread implementation of any proven effective treatments or vaccines, as well …