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Under these regulations, each clinical investigation regulated by FDA must be reviewed and approved by an IRB before the investigation may be initiated

The IRB must review the proposed research at convened meetings at which a majority of the members of the IRB are present, and the IRB must approve or require modifications to the research protocol, informed consent document, and other study-related materials as a condition of approval

For sites relying on the Veridian Central IRB, the Form 1572 must identify the Veridian Central IRB as the responsible IRB

114(b)(1) provides: "Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States [

] Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that takes place within the United States

The compliance date for the sIRB mandate was January 20, 2020, meaning that all cooperative research conducted or supported by a federal department or agency that is subject to the Common Rule must utilize a single IRB of record since that date