Pandemic Pandemonium
Authors: James Brian Byrd, Natalie Bello, Michelle N. Meyer
Journal: Circulation (2020)

thicists and researchers have written about concerns unique to conducting clinical research on pandemics.Less guidance is available, however, about conducting unrelated clinical research during a pandemic.On what grounds should we pause or continue studies that do not shed direct light on the pandemic?In the United States, most clinical research is subject to review by an institutional review board, which applies federal regulations known as the Common Rule that, in turn, reflect the ethical principles developed in the Belmont Report.An institutional review board may approve a study only if it finds that risks to participants are reasonable in relation to the expected benefits to them, if any, plus the expected benefit to society in the form of knowledge production.After a study has been approved, intervening events that change that risk-benefit balance can change the acceptability of the study.There are reasons, in light of that framework, to pause or end some clinical research (Figure).In particular, investigators, institutional review boards, and organizational leadership should consider whether a study now poses increased risks to participants, researchers, or bystanders.In-person research procedures may undermine critical public health measures such as social distancing, which are especially important in healthcare settings.Clinical research is often conducted at academic medical centers, facilities that treat many critically ill patients.Participants who are infected and travel to healthcare settings for research procedures might spread the virus among a community's most vulnerable members who are seeking medical care and cannot feasibly choose to practice social distancing.Although one of the Common Rule's moral blind spots is that it does not consider risks to either third parties or researchers, broader ethical principles require that we consider their interests when deciding whether to pause research during a pandemic.The study protocol itself might place participants at risk if they become ill.Beyond obvious examples, such as the study of immune-modulating drugs to treat non-life-threatening conditions, other studies might also need to be paused for this reason.One of the authors (J.B.B.) is performing a study that involves administration of very high-sodium and low-sodium diets.It is unknown whether coronavirus disease 2019 (COVID-19) might be poorly tolerated by people on these diets.In addition, the supply chain of materials is in question.For these reasons, the need for social distancing, and the lack of potential benefit to participants, he has paused study visits.On the other side of the risk-benefit ledger, disruptions caused by the pandemic may reduce data quality, with the result that risks assumed by participants would no longer be balanced by sufficient social benefit in the form of knowledge production.A growing number of clinical trials are multinational.Results may be skewed if the study is not implemented as planned because of changing resource allocation from research to clinical care at some but not all study sites.Study