COVID-19 Test Us: A Case for Embedding Ethics and Regulatory Expertise
UMass Chan AffiliationsTan Chingfen Graduate School of Nursing
Document TypeJournal Article
Rapid Acceleration of Diagnostics (RADx) Tech program
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AbstractA 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.
SourceTaylor 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.
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/51795
Funding and AcknowledgementsNIH Clinical Center
RightsThis work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/
Except where otherwise noted, this item's license is described as This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/