FDA 483 - Memorial Hospital of Rhode Island IRB - April 17, 2019

An FDA inspection was conducted at Memorial Hospital of Rhode Island IRB, located in Pawtucket, RI, from April 11 to April 17, 2019. The inspection revealed an observation concerning the Institutional Review Board's record-keeping practices, specifically related to meeting minutes. The primary issue identified was that minutes of IRB meetings were not prepared and maintained with sufficient detail to accurately reflect actions taken by the board. This included a lack of documentation regarding voting outcomes, such as the number of members voting for, against, or abstaining from specific decisions. For instance, the approval of FDA-regulated studies during the August 4, 2015 committee meeting was noted as lacking documented voting records. This observation indicates a need for improved adherence to regulatory standards governing IRB operations and documentation. Memorial Hospital of Rhode Island IRB is expected to respond to the FDA's observation by detailing the corrective actions it has taken or plans to implement to ensure complete and accurate documentation of all IRB meeting decisions and votes.