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COVID-19 Test Us: A Case for Embedding Ethics and Regulatory Expertise

Taylor, Holly A.
Hale, Janet Fraser
Centola, Michael
Blodgett, Allison
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Abstract

A key aspect of the National Institutes of Health (NIH) funded Rapid Acceleration of Diagnostics (RADx) Tech program was an active Clinical Studies Core including Committees with unique expertise to facilitate the development and implementation of studies to test novel diagnostic devices for Covid-19. The Ethics and Human Subjects Oversight Team (EHSO) was tasked to provide ethics and regulatory expertise to stakeholders in the RADx Tech effort. The EHSO developed a set of Ethical Principles to guide the overall effort and provided consultation on a wide range of ethical and regulatory concerns. Having access to a pool of experts with ethical and regulatory knowledge who met weekly to tackle issues of importance to the investigators was critical to the overall success of the project.

Source

Taylor HA, Hale JF, Centola M, Blodgett A. COVID-19 Test Us: A Case for Embedding Ethics and Regulatory Expertise. IEEE Open J Eng Med Biol. 2022 Nov 1;3:167-170. doi: 10.1109/OJEMB.2022.3217431. PMID: 36846360; PMCID: PMC9955894.

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DOI
10.1109/ojemb.2022.3217431
PubMed ID
36846360
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Funding and Acknowledgements
NIH Clinical Center
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This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/