Over the past few months, the IRB offices have been considering changes to streamline their processes and to decrease the turnaround times for new protocols. Currently, the IRB processes for new protocols involve submission of studies for a stated deadline with subsequent review by the fully convened Committee three weeks later. Currently, there are two deadlines per month. In reviewing data from the past six months, approximately 60% of submissions that were submitted by the deadline are not able to be reviewed by the IRB Committee. Reasons for the delay include lack of a response to the IRB administrative review, lack of submission of budget and contract documents to the Office of Clinical Research, as well as other issues, including incomplete submissions.
In light of these findings, the IRB office (effective July 1) will no longer post new submission deadlines. The IRB staff will process protocol submissions for full review on a weekly basis. The IRB administrators will complete the preliminary review process and upon receipt of a “complete” IRB submission, the protocol will be placed on the next available meeting agenda.
The IRB staff has prepared guidance for what constitutes an acceptable submission to be considered for preliminary processing as well as what constitutes a “complete” submission in order to be assigned to a meeting agenda. The IRB staff will follow these standardized, published checklists when determining what studies are ready for IRB review.
Our goals are to increase standardization of IRB admin comments and decrease the protocol turnaround times between acceptance for submission and final approval. We will be tracking this data over the next several months to determine whether or not this change in process has resulted in a decrease in turnaround times.