Evaluation of the National Dental PBRN central IRB since its inception in 2014 until 2025.

Introduction: The National Dental PBRN Central Institutional Review Board (CIRB) at the University of Alabama-Birmingham (UAB) was established in 2014 to reduce administrative burden while allowing Local Context Review (LCR) by local institutions (LIs). The National Institutes of Health implemented a single IRB policy in 2018; CIRB meets its requirements. Methods: The CIRB reviews study protocols, documents, consent forms, and HIPAA forms. Once CIRB approval is obtained, the study packet is sent to LIs for LCR. LIs may revise specific sections agreed on in reliance agreements but must make determinations regarding the HIPAA Privacy Rule. Once a LI completes a reliance agreement and the LCR, the CIRB becomes responsible for subsequent reviews. Results: The CIRB has reviewed 27 studies, 8 of which were declared exempt; LIs are responsible for exempt studies. Nineteen studies were declared expedited or full review. For all expedited/full review studies combined, the mean (SD) calendar days from initial submission to approval was 55.2 (35.2) days; for studies with available tracking, 35% of this time was due to waiting on study investigator responses. Post-approval submissions for 19 studies, such as revision amendments, continuing reviews, site amendments, prompt reports, and personnel amendments, totaled to 374. Conclusions: The CIRB did not ensure a shorter approval time because LCR approvals must wait for initial CIRB approval, but LIs did benefit by starting with an already-approved packet. However, substantial benefits were realized later because subsequent amendments and annual reviews only required CIRB review, saving LIs from involvement in these reviews.