By Robert Steel, Lara Buchak, Nir Eyal

Multiple authors believe that the development of coronavirus vaccines could be substantially accelerated through the use of challenge trials, in which participants are deliberately exposed to the virus. The tremendous loss of life and health and significant social and economic upheaval from ongoing worldwide pandemic make acceleration of the vaccine development important. More than thirty thousand people have already signed up to potentially participate in coronavirus challenge trials, should they go forward.

Yet other authors worry that too much remains unknown about the novel coronavirus for it to be ethical to deliberately infect anyone with it, not even altruistically-minded consenting adults. Our full article expands on several arguments we see in bioethicists’ public remarks on the subject, before going on to rebut them. In our view, ongoing uncertainty about the novel Coronavirus should not delay challenge trials.

One argument we address holds that because we lack adequate knowledge concerning the novel coronavirus, participants cannot offer their ‘truly informed’ consent to be infected, so challenge trials cannot ethically be conducted. Like the authors cited in our article, prominent physician Michael Rosenblatt has recently claimed that participants ‘should be provided with all the relevant information about the risk they are considering. But that is impossible for such a new disease.’ But this argument reveals misunderstanding of the validity conditions for informed consent.

Informed consent requires that researchers share their best concurrent understanding with potential participants and ensure comprehension. It does not require researchers to be omniscient. If valid informed consent really did require participants to be provided with all relevant objective truths, then many completed studies would have to be retrospectively deemed nonconsensual, and hence legally and morally problematic, simply because our understanding of the truth has evolved since they were conducted. Fortunately, this is not so.

Outside of the argument from informed consent, we also tease out and reject several other putative arguments seeking to explain why uncertainty might render challenge trials premature or inappropriate. Those arguments claim that knowledge about which young individuals are at highest objective risk from Coronavirus infection is lacking, that we lack understanding of COVID’s mechanisms, that later we may know more about COVID and how to cure it, and that even if risk in well-conducted challenge studies is likely to remain tolerable, we should err on the side of caution by assuming a risk as high as it could possibly be.

Paper title: Why Continuing Uncertainties Are No Reason to Postpone Challenge Trials for Coronavirus Vaccines

Author(s): Robert Steel, Lara Buchak, Nir Eyal

Affiliations: Center for Population-Level Bioethics and Department of Philosophy, Rutgers University, New Brunswick, NJ, USA; Department of Philosophy, Princeton University, Princeton, NJ, USA; Department of Health Behavior, Society and Policy, Rutgers School of Public Health, Piscataway, NJ, USA; Department of Philosophy, School of Arts and Sciences, Rutgers University, New Brunswick, NJ, USA.

Competing interests: None.