“Good news! You have antibodies, so you’re immune to COVID-19.” How relieved would we be to hear that? I could move throughout my place of work, or my grocery store, with added security. I would muse about a vetted cohort of immune providers to care for patients with COVID-19. PPE could be conserved so that it could be plentiful for the providers who volunteered themselves to remain in the fray despite their antibody-unknown status. The lives of health care providers could be saved.
But we are not in normal times. The tests being developed to assess immunity to COVID-19 are retrofitted from materials previously validated for different infections. While tests are being developed with the most rigorous oversight possible, there is a risk that the results of early testing for COVID-19 immunity will yield an unusually high number of false-positive and negative results. In non-pandemic circumstances, researchers have the time to optimize the sensitivity and specificity of their testing. What are the ethical obligations of researchers to assure test validity in the current environment?
The easy answer would be to test individuals for research purposes only. In non-pandemic times, preparing for the safety of future medical providers is ethically supportable because the benefits of the research are gained by exposing research participants to (hopefully) minimal risk. In the current time, testing medical professionals’ serologies is acting in a just manner as many of us will find ourselves on the front line of future smaller COVID-19 pandemics. This fulfills one of the three basic ethical principles the Belmont Report requires when conducting research with human participants, specifically that those bearing the burden of research will also stand to benefit from the research.
Unfortunately, in the current environment obtaining serologic studies for only research purposes is a failure to uphold another obligation per the Belmont report, that which requires beneficence that “protect(s) (participants) from harm (and) also by making efforts to secure their well-being.” Should a researcher have reasonable data to suggest whether a medical provider could care for patients with COVID-19 with minimal risk to herself (positive antibody testing) or significant risk to herself (negative antibody testing), it would be the beneficent action to release her testing results to her.
Participants should receive their results simply because they are autonomous agents who have the ability to weigh the risks and potential benefits of modifying their behaviors based on serology testing per the Belmont Report’s ethical principle of “respect for persons.” Conversely, it could be argued that the ramifications of a person modifying her behavior after a false-positive result are so great, truly life-risking, that participants should not receive their test results in order to protect them from such a fate. In 2018, Guillemin et al. found that research participants place their trust in research institutions because of their systems of research ethics, reputation, and prestige. When our research participants trust us to protect them, it does not feel ethically-supportable to send them out into a COVID-infected world with false-positive serologic results. However, autonomous research participants must be trusted to evaluate the risks and benefits of research per their own values: It is equally likely that a provider with a false positive result will march right into his shift in a “hot spot” emergency room as it is a provider with a false negative result.
This gives me pause. Despite information with varying amounts of certainty, providers are continuing to care for patients with COVID-19. The altruism that can prompt research participation may be the same altruism that prompts us to care for our patients despite the constantly shifting obstacles to do so. True, we are paid (usually well) for our work. True, we have fiduciary responsibilities to our patients. Lastly, we all took professional oaths to be of service to our patients. Do all of those qualities make us a vulnerable population for participation in research regarding immunologic protection against COVID-19?
Will a medical provider whose research serologies show positive immunity feel unduly obligated to care for patients with the infection? Will he commit to exposing himself to the mentally and emotionally difficult work of caring only for patients with a high risk of death? Will he indefinitely self-isolate, living in a guest bedroom or hotel, because his immunity does not assure similar immunity in his loved ones? Could his institution coerce him into learning skillsets outside of his chosen specialty? Can organizations obligate providers to change their behaviors based on imperfect data? Because what if the provider’s unvalidated test results showed falsely positive immunity to a deadly virus? A vulnerable research participant is not one who can reliably act in an autonomous manner. By trying to do the right thing and provide medical professionals with the best information we have given the constraints in a pandemic, researchers may be causing harm to the very group of people who volunteered to help them solve a life-and-death problem.
Recognizing the importance of this work, preventing medical professionals from serving as research subjects to ascertain personal immunity to COVID-19 is unacceptable. Knowing (or deferring to know) testing results will allow research participants to do what they please with the information, be it carry on as they did prior to testing or planning a professional pivot that moves them towards or away from the front lines as they see fit. To prevent institutional coercion and protect providers from becoming members of a vulnerable population, participants’ immunity to COVID-19 should not be accessible by their places of employment. While this may minimize the benefit achieved by testing an institution’s workforce for immunity, it protects frontline workers from being exploited; exploited with the best of intentions, but nonetheless exploited. As we move away from the dark period in which ICU beds and mechanical ventilators are critically scarce, we must protect the most precious scarce resource that will be required for the next phase of the pandemic: Our altruistic bedside provider research participants.
Jessica Turnbull is a pediatric critical care physician and bioethicist.
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