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<p>The boundary between quality improvement projects and clinical research requiring IRB oversight remains nebulous with finalization of the Common Rule on Jan. 18, 2017. There was some attempt to address this situation in the proposed new rule, but ultimately the solutions were deemed problematic and the issue was left unresolved.</p>

Gray Zone Remains Between Clinical Research and Quality Improvement Efforts

With no resolution by HHS, calls for a non-IRB alternative