FDA WARNING_LETTER - Kootenai Medical Center IRB - May 29, 2013

On November 15, 2013, the FDA issued a Warning Letter to Kootenai Hospital District's IRB following an inspection from May 14-29, 2013. The inspection aimed to assess compliance with 21 CFR Part 56 (IRBs), Part 50 (Protection of Human Subjects), and Part 812 (IDE).

The FDA identified serious violations, including: 1. **Failure to ensure research involving children complies with 21 CFR Part 50, Subpart D [21 CFR 56.111(c)]**: The IRB approved multiple studies involving adolescents with schizophrenia or bipolar disorder without finding that the investigations satisfied the criteria in applicable sections of Subpart D. The IRB's response was deemed inadequate due to a lack of detail and supporting documentation for corrective actions. 2. **Failure to notify investigators of required modifications [21 CFR 56.109(e)]**: The IRB did not notify investigators in writing of conditions of approval for several clinical investigations, potentially placing subjects at increased risk. The IRB's response was inadequate as procedures did not require written notification and lacked a recurrence prevention plan. 3. **Failure to review proposed research at convened meetings with a majority present [21 CFR 56.108(c)]**: The IRB approved FDA-regulated research at meetings where a majority of members