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- Title
Human Challenge Studies With Wild-Type Severe Acute Respiratory Sydrome Coronavirus 2 Violate Longstanding Codes of Human Subjects Research.
- Authors
Spinola, Stanley M; Broderick, Camilla; Zimet, Gregory D; Ott, Mary A
- Abstract
This 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.
- Subjects
HUMAN research subjects; HUMAN experimentation; COVID-19; SARS-CoV-2; CODES of ethics
- Publication
Open Forum Infectious Diseases, 2021, Vol 8, Issue 1, p1
- ISSN
2328-8957
- Publication type
Article
- DOI
10.1093/ofid/ofaa615