FDA WARNING_LETTER - Providence Hospital Institutional Review Board - November 03, 2009

On January 6, 2010, the FDA issued a Warning Letter to Providence Hospital following an inspection of its Institutional Review Board (IRB) from October 27 to November 3, 2009. The inspection aimed to assess compliance with 21 CFR Part 50 (Protection of Human Subjects), Part 56 (Institutional Review Boards), and Part 812 (Investigational Device Exemptions), particularly for device investigations.

The FDA identified serious violations of 21 CFR Part 56. Key deficiencies included:

1. **Inadequate Written Procedures (21 CFR 56.108(a), (b), (c)):** The IRB lacked written procedures for initial and continuing review, reporting findings to investigators and the institution, determining review frequency, managing changes to approved research, and promptly reporting unanticipated problems, serious noncompliance, or suspension/termination of IRB approval to the FDA and institutional officials. 2. **Failure to Ensure Majority and Nonscientific Member Presence at Meetings (21 CFR 56.108(a), (b), (c)):** The IRB reviewed FDA-regulated studies without a majority of members present, and without at least one member whose primary concerns were nonscientific. For example, the June 10, 2009, and June 20, 2007, meetings lacked a majority quorum, and included non