That’s a lot for a local IRB to handle, so Northwell has long been following an sIRB model, even without an FDA mandate. “The change to moving to a single IRB is not going to be a problem for ...

The revisions, also referred to as the 2018 requirements, included a mandate that new cooperative ... the Food and Drug Administration (FDA), and other regulatory agencies or sponsors as applicable.

The U.S. Food and Drug Administration (FDA) published the draft guidance ... It may also include an intentional departure from the IRB-approved protocol for a single participant even when ...

WCG IRB Copernicus Group (WCG) has combined its five IRBs into a single IRB called “WCG IRB.” This includes Western IRB, Copernicus Group IRB, Aspire IRB, New England IRB, and Midlands IRB. All new ...