Human Challenge Studies with Wild Type SARS-CoV-2 Violate Longstanding Codes of Human Subjects Research

Spinola, Stanley M; Broderick, Camilla; Zimet, Gregory D; Ott, Mary A

This manuscript explores the ethics of human inoculation experiments in young healthy adults with wild type SARS-CoV-2 as a tool to evaluate vaccine efficacy in the context of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report and in the context of dose response relationships with infectious agents. Despite societal pressure to develop a SARS-CoV-2 challenge model to evaluate vaccines, we argue that there are substantial risks that cannot be adequately defined because the dose of SARS-CoV-2 that causes severe disease in young adults is unknown. In the absence of curative therapy, even if a volunteer consents, longstanding ethical codes governing human subjects research preclude the conduct of such experiments.