Human Infection Challenge Studies: a Test for the Social Value Criterion of Research Ethics

• Published in: mSphere Vol. 5; no. 4
• Main Author: Evans, Nicholas G
• Format: Journal Article
• Language: English
• Published: United States American Society for Microbiology 15-07-2020
• Subjects: Betacoronavirus; Biomedical Research; Biomedical Research - ethics; Biomedical Research - methods; challenge studies; Clinical Science and Epidemiology; Clinical Trials as Topic; Clinical Trials as Topic - ethics; coronavirus; Coronavirus Infections; Coronavirus Infections - drug therapy; Coronavirus Infections - prevention & control; Coronaviruses; COVID-19; Ethics, Research; global health; Humans; Immunization; Pandemics; Pandemics - prevention & control; Perspective; Pneumonia, Viral; Pneumonia, Viral - drug therapy; Pneumonia, Viral - prevention & control; Research ethics; SARS-CoV-2; Social Values; Vaccines; Viral Vaccines - therapeutic use; Zika virus; United States > US; COVID-19; global health; coronavirus; challenge studies; research ethics
• ISSN: 2379-5042; 2379-5042
• DOI: 10.1128/mSphere.00669-20

Human infection challenge studies involving the intentional infection of research participants with a disease-causing agent have recently been suggested as a means to speed up the search for a vaccine for the ongoing coronavirus disease 2019 (COVID-19) outbreak. Calls for challenge studies, however, rely on the expected social value of these studies. This value represents more than the simple possibility that a successful study will lead to the rapid development and dissemination of vaccines but also some expectation that this will actually occur. I show how this expectation may not be realistic in the current political moment and offer potential ways to make sure that any challenge trials that arise actually achieve their goals.