FDA WARNING_LETTER - Valley Health/Winchester Medical Center IRB - February 01, 2013

The FDA issued a Warning Letter to Valley Health's IRB following an inspection from January 29 to February 1, 2013, which revealed serious, repeated 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 follow FDA regulations regarding expedited review procedures [21 CFR 56.110(b)(2)]**: The IRB improperly used expedited review for significant risk device studies and major protocol changes (e.g., adding serious adverse events, incorporating additional devices), which should have undergone full board review. This was a repeat violation from a 2008 inspection. Furthermore, an unqualified individual (Ms. Deborah Moore, IRB Manager) approved a significant protocol amendment under expedited review. The IRB's revised SOPs were deemed inadequate for not sufficiently distinguishing major changes from minor/administrative ones. 2. **Failure to follow written procedures for conducting initial and continuing review of research [21 CFR 56.108(a)(1)]**: The IRB failed to inform the full board of research changes approved under expedited review, contrary to its own SOPs requiring dissemination and documentation in meeting minutes. This included amendments to informed consent and the addition of treatment arms. The IRB's response and revised SOPs were inadequate, lacking assurance that