By Hayden P. Nix and Charles Weijer
In a recent blog post, we sought to answer the narrow question: is altruistic kidney donation sufficiently analogous to participation in a SARS-CoV-2 challenge study to justify the risks of SARS-CoV-2 challenge studies? We argued that three morally relevant differences (the risk of adverse effects, the availability of alternatives, and the potential to undermine public trust) undermine the analogy, and that “[a]dvocates of SARS-CoV-2 challenge studies must look elsewhere to justify the level of risk in these studies.”
In response, Rohrig and Manheim argue that the analogy between SARS-CoV-2 challenge studies and altruistic kidney donation is “separate from the analysis and justification of the risk[s]” of SARS-CoV-2 challenge studies. Acknowledging that no analogy is perfect, they argue that the analogy has been “helpful for public understanding” of the risks of SARS-CoV-2 challenge studies.
Justifying the risks of SARS-CoV-2 challenge studies
The analogy has been used to justify the risks of SARS-CoV-2 challenge studies. In a recent article McPartlin, Rohrig, and Morrison state:
“According to a principle of “risk parity,” if we allow some people to take certain risks to help save lives then we should allow other people to take similar, voluntary risks when there are comparable benefits. Put concretely: altruistic risks allowed in operating rooms (for example, kidney donation) should be allowed in clinical research facilities, such as in challenge trials.”
This is not a descriptive statement about the level of risk posed by kidney donation and SARS-CoV-2 challenge studies. It is a normative statement, about what “should be allowed.” In this statement, the analogy is used to justify the risks posed by SARS-CoV-2 challenge studies.
Communicating the risks of SARS-CoV-2 challenge studies
The analogy is not helpful for building the public’s understanding of the risks of challenge studies. In addition to risk magnitude, conveying the context in which a risk occurs is critical for effective risk communication. Kidney donation and SARS-CoV-2 challenge study participation are altruistic acts that pose a similar risk of death to volunteers. These similarities give the analogy intuitive appeal. But, as we have argued, morally relevant differences distinguish the contexts in which these risks occur. Understanding these differences is critical because analogies can be misleading when the analogs are similar enough to evoke an intuition, but differ in important ways. Selectively communicating the similarities of the analogy, while neglecting the differences, fails to properly educate the public and transforms the analogy into a rhetorical device. This undermines the goal of building public understanding.
Advocates for SARS-CoV-2 challenge studies use a series of analogies to bolster a central thesis with which we disagree. They invoke the acceptability of risks voluntarily assumed by kidney donors, firefighters, and search and rescue teams to refute paternalism and argue that if “the known risks are made clear to volunteers, and the life-saving benefits are probable, the altruistic decision should rest in the hands of the volunteers.”
However, consent and the prospect of saving lives are not sufficient to justify exposing people to any level of risk. Paternalism is justified when an individual’s decision may interfere with professional duties or result in harm to others. Even with informed consent, a patient with suboptimal kidney function is not permitted to donate a kidney; firefighters are not permitted to enter a burning building when the incident commander rules that the risks are too high; and search and rescue teams are not permitted to enter a terrain when the conditions are too dangerous. In each case, paternalistic regulations are in place to uphold professional duties and limit risks to others.
For similar reasons, volunteers ought not be allowed to participate currently in SARS-CoV-2 challenge studies. In the absence of proven and effective rescue medication, such studies would violate the researchers’ duty to do no harm. Further, reports of adverse events in SARS-CoV-2 challenge studies seem likely to erode the public’s trust, thereby undermining the uptake of covid-19 vaccines.
Authors: Hayden P. Nix1,2 and Charles Weijer3
Affiliations: 1MD Student, Schulich School of Medicine & Dentistry, Western University, Canada; 2MSt Student, University of Oxford, UK. 3Professor Department of Medicine, Epidemiology & Biostatistics, and Philosophy, Western University, Canada.
Competing Interests: HPN has no competing interests to declare. CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute (RTI) International.