Somerset Medical Center IRB – FDA EIR, Sep 30, 2016

The FDA conducted an inspection of the Somerset Medical Center Institutional Review Board (IRB) in Somerville, NJ, from September 7 to September 30, 2016. This was the first inspection for this IRB, carried out under the FY 2016 Routine Institutional Review Board Bioresearch Monitoring Assignment, in compliance with Program 7348.809 for Institutional Review Boards.

The inspection focused on the IRB's procedures, membership composition, meeting minutes, communications with clinical investigators, informed consent documents, and study monitoring activities from 2014 to 2016. Key violations identified during the inspection included:

1. Allowing a member with a conflicting interest to participate in the initial and continuing review of a project. 2. Failing to ensure that proposed research, other than expedited reviews, was reviewed at convened meetings with a majority of IRB members present.

These deficiencies were documented in the Form FDA-483. The IRB is required to address these issues to ensure compliance with federal regulations governing IRB operations, which are designed to protect the rights and welfare of human research subjects. The IRB must implement corrective actions to prevent recurrence of these violations and ensure adherence to regulatory requirements for IRB reviews and decision-making processes.