So, what are potential ethical problems with this? A thread on #humanchallenge against #COVID19 1/n
The most obvious one is the level of risk: we usually consider that there is a maximum level there, which even very well-informed volunteers cannot be allowed to overstep. We have the right to refuse human sacrifice in our name.
Would a human challenge study overstep this maximum? That’s actually not so clear. It is not an exact threshold, but one on which reasonable people can disagree.
The CIOMS guidelines mention that the threshold is overstepped in the absence of an effective treatment. That is usually understood to mean something that actually cures you, not something that merely decreases the risk of death in part.
So, that would be a no: with remdesivir, we are is not there yet
On the other hand, the diseases for which these reflections happened in the past tended to be even more lethal than COVID19
Moreover, if an attenuated strain could be devised, this would decrease the risk of a human challenge study and may bring it into the acceptable zone as far as risk is concerned.
Ultimately, a research ethics committee will have to decide this.
Risk, however, is not the only issue here
One way to lower the research related risk would be to recruit participants from a highly endemic region. This means the risk they take by participating is not so great, in comparison to the risk that they would run anyway
Recruiting participants from such regions, however, means those whose governments have been either unable or unwilling to protect them. Would these governments then give them access to the vaccine? If not, there is an obvious problem of fairness
In addition, participants in such trials will have to be very low risk indeed, and this raises issues for the generalisation of results to much more vulnerable target populations down the line
yes, there is also the problem of creating a precedent, not in the legal sense but in a more general one
Finally (for now), normal@phase 3 also exist to detect more rare and more long-term side-effects than those identified by phase 1 studies. Since the point of a human challenge study is to shorten follow-up, it would be less affective in doing that
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