Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution's Experience.

Abstract

We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina's Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to trainees and junior faculty, may be associated with better success in obtaining IRB approval as well as preventing the unnecessary submission of projects that are not research and would therefore not require IRB review or approval.