Mount Sinai School of Medicine IRB #5 - Board D – FDA EIR, Jan 31, 2014

An FDA inspection of the Mt Sinai School of Medicine I.R.B., located in New York, NY, was conducted from January 23 to January 31, 2014. This routine surveillance inspection assessed the IRB's adherence to regulatory requirements for human subject protection in clinical research. The inspection identified several observations. It was noted that two meetings of IRB "D" proceeded without the required non-scientific member. A review of the IRB's Standard Operating Procedures (SOPs) revealed multiple deficiencies, including inadequate discussion regarding reporting requirements for study terminations and suspensions, guidance for studies involving children (Subpart D), and definitions for significant and non-significant risk devices. Additionally, the SOPs lacked a clear procedure for managing adverse experiences and did not explicitly state the requirement for non-scientific and non-affiliated members. Minor issues with incorrect and missing regulatory references within the SOPs were also observed, alongside confusion regarding the scientific or non-scientific status of one voting member. These findings were documented on an FDA Form 483, and the institution committed to corrective actions. The Mount Sinai IRB submitted a written response on February 10, 2014, which the FDA found adequate. Consequently, the inspection was classified as "Voluntary Action Indicated" (VAI), indicating that the firm's corrective actions were satisfactory, and no further FDA follow-up was deemed necessary.