FDA WARNING_LETTER - Christian Hospital Northeast-Northwest - December 02, 2011

The FDA issued a Warning Letter to Christian Hospital Northeast-Northwest following an inspection of its Institutional Review Board (IRB) that concluded on December 2, 2011. The inspection, part of the Bioresearch Monitoring Program, found significant violations of 21 CFR Part 56, governing IRB operations and human subject protection.

Key violations include: 1. **Failure to follow written procedures (21 CFR §§ 56.108(a) and 56.115(a)(6)):** The IRB did not maintain attendance sign-in sheets, consistently ensure physician review of protocols, prevent a member and alternate from voting simultaneously, or document the period of approval for research. This is a repeated violation from a 2003 inspection. 2. **Failure to maintain adequate documentation (21 CFR § 56.115(a)):** Meeting minutes lacked sufficient detail on voting (e.g., number of votes for/against/abstaining), showed discrepancies with attendance records, failed to document conflicts of interest, and membership rosters were inaccurate or incomplete. This is a repeated violation from 1998 and 2003 inspections. 3. **Failure to ensure proper meeting quorum and composition (21 CFR § 56.108(c)):** The IRB voted on research and adverse events without a majority of members present, and approved protocols