Spinola, Stanley M.Broderick, CamillaZimet, Gregory D.Ott, Mary A.2021-04-132021-04-132021-01Spinola, S. M., Broderick, C., Zimet, G. D., & Ott, M. A. (2021, January). Human Challenge Studies With Wild-Type Severe Acute Respiratory Sydrome Coronavirus 2 Violate Longstanding Codes of Human Subjects Research. In Open Forum Infectious Diseases (Vol. 8, No. 1, p. ofaa615). US: Oxford University Press. https://doi.org/10.1093/ofid/ofaa615https://hdl.handle.net/1805/25629This manuscript explores the ethics of human inoculation experiments in young healthy adults with wild-type severe acute respiratory sydrome coronavirus 2 (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.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalethicshuman challenge experimentsSARS-CoV-2Article