FDA 483 - Univ CO Boulder Institutional Review Board - July 10, 2019

The FDA issued a Form 483 to the University of Colorado at Boulder's Institutional Review Board (IRB) following an inspection. Observations included a lack of written procedures for initial research review, failure to comply with safeguards for children in clinical investigations, and deficiencies in informed consent documents regarding alternate treatments and FDA inspection disclosures. These findings indicate significant issues with the IRB's oversight and documentation practices.