tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2020 Dec 28;8(1)
faa615.
doi: 10.1093/ofid/ofaa615. eCollection 2021 Jan.
Human Challenge Studies With Wild-Type Severe Acute Respiratory Sydrome Coronavirus 2 Violate Longstanding Codes of Human Subjects Research
Stanley M Spinola[SUP] 1 2 3 [/SUP], Camilla Broderick[SUP] 4 [/SUP], Gregory D Zimet[SUP] 5 [/SUP], Mary A Ott[SUP] 5 6 [/SUP]
Affiliations
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.
Keywords: SARS-CoV-2; ethics; human challenge experiments; vaccines.
. 2020 Dec 28;8(1)
faa615.doi: 10.1093/ofid/ofaa615. eCollection 2021 Jan.
Human Challenge Studies With Wild-Type Severe Acute Respiratory Sydrome Coronavirus 2 Violate Longstanding Codes of Human Subjects Research
Stanley M Spinola[SUP] 1 2 3 [/SUP], Camilla Broderick[SUP] 4 [/SUP], Gregory D Zimet[SUP] 5 [/SUP], Mary A Ott[SUP] 5 6 [/SUP]
Affiliations
- PMID: 33506070
- PMCID: PMC7798584
- DOI: 10.1093/ofid/ofaa615
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.
Keywords: SARS-CoV-2; ethics; human challenge experiments; vaccines.