Narrative Inquiry in Bioethics

The first reports of a novel SARS coronavirus emerging from China in early January of this year did not capture my attention as they should have. This, I reasoned at the time, was a virus halfway around the world, probably an oddity of interest only to virologists in East Asia. I would soon learn, however, that this would evolve into a plague, the likes of which had not been seen in a generation. As inconceivable as it seemed at the time, this virus would eventually affect my work as an Institutional Review Board (IRB) chair in New Mexico. Warily, I watched as the virus entered Europe and the rest of the world. Soon, curiosity in the West transformed into worry, which rapidly gave way to terror. Images of overflowing intensive care units in New York City filled my cellphone screen. Health care workers were forced to use garbage bags for protection after supplies of personal protective equipment (PPE) disappeared. Hospitals ran out of ventilators. (These equipment shortages can be seen documented on the CBS 60 Minutes segment "Sick doctors, nurses and not enough equipment: NYC healthcare workers on the fight against the coronavirus.") Still, the virus moved further and further west from New York, eventually heading for my own borough.

I watched as panicked physicians, patients, and media outlets turned to the research community for answers, desperately hoping cures, vaccines, and preventive measures could be produced. Repurposed drugs and experimental agents with in vitro activity against the virus were rapidly identified. Small, uncontrolled studies began to appear in the literature, many bypassing peer review, feeding scraps of pilot data to a frightened medical community. Clinical trials materialized overnight, as the website 'ClinicalTrials.gov' exploded with hundreds of new COVID-19 studies. At the local level, our investigators, clinicians, hospital administrators, and the populace they served advocated for the initiation of clinical trials in our hospital. Researchers wished to contribute their expertise to help generate data. Administrators hoped to offer our hospital as a trial site for a number of coveted experimental therapies for the community, while patients were willing to volunteer for studies of these new treatments. From one perspective, such efforts were laudatory, and a remarkable demonstration of determination and altruism. From [End Page 61] another perspective, the clinical trials arising from these efforts would soon force me to confront the idea of therapeutic misconception and misestimation as never before.

Therapeutic misconception—as defined by Henderson, Churchill, Davis, et al. in the journal PLOS Med.—is the failure to appreciate the distinction between the goals of research, which are to collect data to contribute to scientific knowledge, and the goals of clinical medicine, which are to improve the health of patients. Pentz, White, Harvey, et al., in the journal Cancer, define therapeutic misestimation as the misestimation of the level of risk and chance of benefit in a clinical trial. As in other hospitals around the country, patients in our hospital wanted cures, and many were willing to be the recipients of untested drugs in their quest for such cures. This simple fact kept me awake many nights before an IRB meeting that Spring. Would any of our potential research subjects actually consider the warnings in a consent form about the possible risks and lack of proven benefit for an investigational therapy when offered the chance to participate in a COVID-19 clinical trial? Particularly after these potential study subjects had viewed the same images of death in New York that I had? For that matter, would our worried health care workers be able to objectively appraise the opportunity to participate in trials of preventive measures against the virus, such as vaccines and prophylactic drugs, after they had viewed the images of health care workers in New York using garbage bags as PPE? Internet and media sources continually promulgated a steady stream of real-time updates on seemingly every development in the ongoing search for a cure or a vaccine. No longer restricted to the esoteric domain of medical...