Over 30,000 persons in 140 countries have volunteered for human challenge trials of Covid-19 vaccines, according to the organization 1Day Sooner.  They are willing to be deliberately infected with the Coronavirus after receiving a dose of an experimental vaccine—or a placebo!  Human challenge trials could shave weeks or months off the development time for a vaccine, when reducing it by even one day could save thousands of lives.  Yet, are such trials ethical?

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About John Hooker

T. Jerome Holleran Professor of Business Ethics and Social Responsibility Tepper School of Business Carnegie Mellon University

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  1. John Hooker says:

    Much of the debate surrounding human challenge trials is about medical issues that ethics can’t resolve. Would the trials really accelerate vaccine development, given that it may take months to set them up? If only young people participate, because their risk is low, would the trials measure vaccine effectiveness for old people?

    Nonetheless, ethics can tell us how the medical debate must come out if challenge trials are to be ethical. We must have rational grounds for believing that the total benefit will outweigh the harm. Actually, this utilitarian test is not hard to pass. If the probable development time is reduced by only a few days, a substantial risk to the volunteers is justified. This is because relatively few people are involved in the trials, and many thousands would benefit.

    Yet this doesn’t seem right. Health authorities typically argue, for example, that the risk incurred by experimental subjects must be very low, even though a utilitarian argument does not justify this requirement. The reason for their hesitation is captured in the autonomy principle. Causing illness or death is a violation of autonomy, unless there is informed consent. Or more precisely, imposing a risk that we are rationally constrained to believe will result in debilitating illness or death of at least one person, even if we don’t know who that person will be, is a violation of autonomy—unless everyone exposed to the risk gives informed consent to assuming the risk. You can see why informed consent is such a big topic in medical experimentation.

    Violation of autonomy is interference with an ethical action plan. We all have a number of action plans: I will go to work so I can make a living, I will take care of my kids, I will visit my grandmother, and so on. If I am a challenge trial volunteer, a serious case of the disease could wreck these plans. Even a mild case could give my grandmother a deadly infection if I am not careful about self-quarantine. To give informed consent, I must consciously consider all the ways a case of Covid-19 could mess up my life, or another’s life, and I must deliberately choose to accept the risk. Furthermore, I must be able to explain why I am willing to do this. My explanation need not convince others to do the same, but it must be intelligible enough for others understand why I am doing it.

    Medical researchers know that it’s hard for us humans to think rationally about risk. It’s hard to imagine how horrible illness can be, until it happens. We are notoriously unable to assess what a given level of risk means, much less explain rationally why we are willing to take a 0.1% risk but not a 1% risk. This makes informed consent difficult. It’s why clinical researchers try to ensure that the probability of additional health damage is so low that even irrational subjects can’t underestimate the risk. Often, the subjects must already be incurably ill, or there must be a relatively easy cure if the trials make them sick. Since neither is true of human challenge Covid-19 trials, the risk of a serious outcome must be essentially zero—or else the young volunteer must be willing to say, while gasping for breath in an ICU bed, that the risk was worth it.

    There are people who can do this, who can understand and accept the meaning of sacrifice in their deepest being. A few such people save many lives by donating kidneys to strangers, precipitating a long chain of transplants, and avoiding the necessity of carefully arranged swaps between pairs of donors who are related to the recipients.

    If Covid-19 human challenge trials are to be ethical, volunteers must be fully aware of what they are doing and the necessity of protecting others, or else the risk to all concerned must be vanishingly small.

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