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This article discusses the exemption of assessments and operations from IRB oversight if they pose minimal risk. It provides insights into the response to OHRP's proposed rule making and highlights the importance of open science and publication frameworks for disseminating learning embedded in health systems.
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2011 Response to OHRP Advance Notice of Proposed Rule Making “Assessments … in support of operations… should not be subject to IRB oversight… unless they impose greater than minimal risk”
2014 JAMA
2016 Response to OHRP Notice of Propose Rule Making
2016 Open Science
2018 Oversight of learning embedded in health systems
2019 Publication frameworks for dissemination of LHS products