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

Overview
Journal IEEE Open J Eng Med Biol
Publisher IEEE
Specialty Biomedical Engineering
Date 2023 Feb 27
PMID 36846360
Authors
Holly A Taylor
Janet F Hale
Michael Centola
Allison Blodgett
Affiliations
Soon will be listed here.
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.

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