Bioethicist Calls for Ethical Overhaul of Vaccine Challenge Studies

Vaccine challenge studies are valuable in the urgent quest for a Covid-19 vaccine, but they present unaddressed structural maladies that jeopardize the ethical treatment of participants, argued physician and bioethicist Carl Elliot in a book review published July 2 in the New York Review of Books. A Covid-19 challenge study would entail the intentional infection of study participants with the novel coronavirus after administration of an experimental vaccine. Elliot points out that though the WHO has not overtly given its blessing, this approach to Covid-19 vaccine research has a diverse range of prominent backers.

Elliot argued for the use of patients whose risk of dying from Covid-19, by virtue of their ages, was minimal. Patients could be sourced from regions in which they were already likely to become infected, he said, and argued that “at least in a challenge study their medical condition would be closely monitored.”

The problem with such an approach is not that risk of death from Covid-19 for study participants can’t be acceptable minimized, Elliot argued, it is that the research community does not typically work to minimize the harm to participants whose very participation is an act of financial survival. Integrating his essay into a review of the book Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals by Jill A. Fisher, Elliot described vignettes of people recruited with financial incentives that did not provide insurance or compensation for the full scope of risks involved in participation in drug and device trials.

“The research subjects are treated as instruments for purposes they don’t identify with, they are drawn from the most vulnerable segments of American society, and the research is often conducted under grim, dehumanizing conditions,” Elliot wrote, “yet this doesn’t have to be the case for Covid-19 vaccine challenge studies.”

Elliot further argued for greater agency for study participants, in which guarantees of follow-up medical care and disability coverage for bad outcomes were negotiable. Elliot suggested that participants demand that research data not be “hidden, spun, or declared proprietary.” The structural changes necessary to make challenge studies less risky and exploitative, according to Elliot, would entail both policy change and the elimination of paid participation in medical trials.

Lamenting the lack of support for such reforms, Elliot reminded readers of their feasibility: “if a nonprofit organization can sign up over 26,000 volunteers for [Covid-19] challenge studies in a matter of months, it should be possible to reform the oversight system so that research subjects are treated fairly.”

Source:

Katie Pincura, DrPh, MPH, MA

Katie Pincura, DrPH, MA, MPH is an Assistant Professor, Teaching Assistant Professor of Health Sciences at Western Carolina University, College of Health and Human Sciences, School of Health Sciences. Dr. Pincura is a graduate of Georgia Southern University. Her research focuses on the intersection of healthcare policy and public health.

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