David Hoffman, Chief Compliance Officer, Carthage Area Hospital.
June 2, 2020
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When Johns Hopkins launched its quality assurance study of central line infection control practices, they exposed a fault line in the medical research community that continues to generate strong opinions about when IRB approval is appropriate
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In addition to the ongoing debate about whether their intervention required IRB approval due to human exposure to harm, the OHRP reaction to the Hopkins study triggered a debate about the need for IRB review as a condition of scholarly publication
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This presentation will explore the lingering impact of the OHRP-Johns Hopkins confrontation. We will discuss how to evaluate application of the common rule to non-patient focused research and medical device improvement efforts