483
Kaiser Foundation Research Institute IRB #8Kaiser Foundation Research Institute IRB #8 – FDA 483, Sep 10, 2024
Record Details
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.
- Inspection date
- September 10, 2024
- Product type
- other
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ID · 422afc63-2f8a-4268-a5f4-ec2bd0a10d45
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