David Hoffman, Chief Compliance Officer, Carthage Area Hospital.
June 2, 2020
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
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
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
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