FDA 483 - Kaiser Foundation Research Institute IRB #8 - September 10, 2024

An FDA inspection of Kaiser Foundation Research Institute IRB #1 in Oakland, CA, revealed significant deficiencies in its oversight of human subject research. The Institutional Review Board (IRB) failed to adequately conduct continuing review, follow up on suspended research, and ensure ongoing compliance for the MITIGATE study. Furthermore, the institution lacks a comprehensive Human Research Protection Program, compromising its ability to protect human subjects.