FDA 483 - Eastern Virginia Medical School IRB - May 03, 2019

Eastern Virginia Medical School IRB received an FDA Form 483 following an inspection conducted from April 29 to May 3, 2019. The inspection revealed two primary observations related to the institutional review board's operations, falling under the regulatory oversight of the Food and Drug Administration. The first observation cited the failure to accurately prepare and maintain a comprehensive list of IRB members. Specific instances showed that board lists for 2016, 2017, and 2018 were not consistently updated with changes in membership, such as additions or removals. This led to discrepancies where individuals were recorded as voting on FDA-regulated studies in meeting minutes but were not listed as active members during those periods. The second observation detailed inadequate record-keeping for IRB meeting minutes, specifically regarding vote transparency. The FDA noted that minutes lacked sufficient detail to accurately reflect voting actions. Problems included inconsistencies between recorded attendance in minutes and actual attendance sheets, and mismatches between the number of members documented as present and the total vote counts for various agenda items. For example, some meetings showed more votes than members present, or vice versa, indicating inaccuracies in the official records of deliberation. In response to these observations, Eastern Virginia Medical School IRB is expected to evaluate the findings and implement corrective actions to ensure compliance with FDA regulations concerning IRB record-keeping and procedural transparency. The FDA 483 serves as a formal notification of these deficiencies, requiring the firm to address them to safeguard the integrity of human subject protection.