During a recent monitoring visit, I came across a scenario that challenged my efforts to ensure compliance with the Institutional Review Board’s (IRB) policies.  For background, an East Coast University/Hospital has a new area of outsourcing for the studies that are being conducted at their institution. The local IRB reviews all Phase I/ II studies and all studies that are funded by the National Institutes of Health (NIH). Phase III and IV trials are outsourced to a central IRB.