FDA WARNING_LETTER - St Joseph Mercy Oakland IRB - April 22, 2013

The FDA issued a Warning Letter to St. Joseph Mercy Oakland Health System following an inspection of their Institutional Review Board (IRB) from April 17-22, 2013. The inspection revealed several violations of 21 CFR Part 56 (Institutional Review Boards), Part 50 (Protection of Human Subjects), and Part 812 (Investigational Device Exemptions).

Key violations include: 1. **Failure to prepare, maintain, and follow written procedures for initial and continuing review of research [21 CFR 56.108(a) and 56.115(a)(6)]**: The IRB failed to document the rationale for Significant Risk/Non-Significant Risk determinations in meeting minutes, lacked procedures for reporting findings to the institution, and failed to review a study's renewal prior to its expiration. 2. **Failure to review proposed research at convened meetings with a majority of members present [21 CFR 56.108(c)]**: The IRB reviewed and approved studies when less than a majority of members were present. 3. **Failure to promptly report to the FDA any suspension or termination of approval and failure to prepare written procedures [21 CFR 56.113 and 21 CFR 56.115(a)(6)]**: The IRB failed to report a suspension of approval to the FDA. 4