FDA 483 - Valley Health/Winchester Medical Center IRB - August 09, 2022

An FDA inspection conducted at Valley Health/Winchester Medical Center IRB from August 1 to August 9, 2022, revealed significant issues in its oversight of clinical studies and general Institutional Review Board (IRB) operations. The inspection, documented on an FDA Form 483, identified three main observations. Firstly, the IRB failed to consistently perform and communicate device risk determinations, approving studies without classifying them as significant or non-significant risk and not notifying investigators when a study was determined to be significant risk. Secondly, the IRB did not maintain accurate and current records of its membership, with rosters from 2020-2022 not reflecting newly added voting members. Thirdly, meeting minutes were deficient, lacking specific details on voting outcomes, such as the exact count of members voting for, against, or abstaining. Additionally, discrepancies were noted between recorded attendance and the number of members participating in votes. These observations highlight areas where the IRB needs to strengthen its procedures and documentation to ensure compliance with federal regulations governing the protection of human subjects in clinical investigations.