Pandemic ethics: The case for experiments on human volunteers

(Rob Dobi for The Washington Post)

Richard Yetter Chappell is an assistant professor in the Department of Philosophy, University of Miami. Peter Singer is professor of bioethics in the University Center for Human Values at Princeton University.

The pandemic has thrown previous moral assumptions into disarray. Most of us now accept restrictions on our freedom of movement and association that would have seemed unthinkable just a few months ago. Yet the research we are willing to do to combat the virus is still governed by assumptions developed in calmer times when less was at stake.

Research ethics normally prohibits exposing human subjects to significant risk. The overriding aim is to prevent their exploitation by researchers whose interests may not coincide with those of the individual patient. But in a pandemic, the overriding aim must be to avoid a potentially catastrophic toll. We all face such heightened risk that restrictions on promising research (beyond the basic requirement of informed consent) could easily prove counterproductive in humanitarian terms.

For example, conventional standards require that new drugs be tested on animals before clinical trials with humans are permitted. For covid-19, sufficiently promising treatments should jump to human clinical trials as soon as is reasonably possible, bypassing the usual lengthy period of animal testing.

There is a precedent for this. In 1986, when AZT first showed promising results in the treatment of AIDS, patients demanded that the drug be made available without going through animal testing. The Food and Drug Administration licensed it the following year, saving many lives.

AIDS had a much higher fatality rate than covid-19. Even so, if we fully inform covid-19 patients about the risks of taking part in an experimental treatment trial, they may reasonably choose to take that risk. When we consider the broader humanitarian benefits of confirming a treatment’s effectiveness much sooner than would otherwise be possible, not to mention the reduced animal suffering involved, there is a strong moral case for allowing patients to make that choice.

Similar arguments support allowing “human challenge” trials to speed development of a vaccine. Ordinarily, testing a candidate vaccine means waiting months to see whether injected subjects are less prone to infection. Deliberately exposing vaccinated volunteers to the virus could produce results much more quickly. If you think no one would volunteer for such a trial, think again. More than 3,000 altruists from 52 countries have already signed up.

Finally, consider research into low-dose controlled voluntary infection, or “variolation,” widely used to inoculate against smallpox before the discovery of vaccination. In the New York Times, scientists Joshua D. Rabinowitz and Caroline R. Bartman note that people who receive a low dose of a virus are more likely to recover than those who receive a high dose, and that this holds for coronaviruses, too. But they then say: “It would be unethical to experimentally manipulate viral dose in humans for a pathogen as serious as the coronavirus.”

Does this ethical judgment make sense in a pandemic? The seriousness of the coronavirus cuts both ways: more risk from the initial low-dose infection, but greater benefits if it does protect them. If we can gain solid evidence that receiving a low dose of the virus leads to a mild case of covid-19, and that such mild cases then bring immunity to further exposure to the virus, we would have found a means of saving hundreds of thousands of lives — and millions of livelihoods. In these circumstances, it seems both reasonable and ethical to invite healthy young volunteers to receive a low dose of the virus, followed by quarantine and medical observation.

In fact, some individuals have already sought deliberately to infect themselves via uncontrolled “coronavirus parties,” despite medical experts urging them not to do so. It would be better for everyone if such individuals instead had the opportunity to volunteer to receive a low dose of the virus as part of a carefully monitored trial. That would be safer for the participants than an uncontrolled infection, and the knowledge that we would gain from such a trial could, in the best-case scenario, lead to a quick end to the pandemic.

We are ethicists, not medical or biological scientists. When it comes to factual beliefs about the pandemic, we defer to expert scientific opinion, as everyone should. But what we ought to do with the facts we have, and how we should go about seeking facts we still lack, are ethical questions. Ethicists have a crucial role to play in this debate.

There is too much that we don’t know about covid-19. The longer we take to find it out, the more lives will be lost. (That’s why the website asking for vaccine volunteers is called “1 Day Sooner.”) If healthy volunteers, fully informed about the risks, are willing to help fight the pandemic by aiding promising research, there are strong moral reasons to gratefully accept their help. To refuse it would implicitly subject others to still graver risks.

Read more:

Read a letter responding to this opinion piece

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