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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.
Following inception in 2005 as a multiregional practice-based research network (PBRN), the “National Dental PBRN” expanded nationwide in 2012, and in 2019 implemented additional organizational changes. The objectives are to: (1) describe the new structure and function of the network; and (2) quantify its scientific productivity since 2005.
Methods:
A national Administrative and Resource Center is based in Alabama; regional and specialty nodes are based in Alabama, Florida, Illinois, Minnesota, Oregon, New York, and Texas. A Network Coordinating Center is based in Oregon. Studies are funded via investigator-initiated grants. Scientific productivity is assessed using specific metrics, including the Relative Citation Ratio.
Results:
To date, 58 studies have been completed or are in data collection or development. These studies have investigated a broad range of topics using a wide variety of study designs. Of the studies that have completed enrollment, 70,665 patients were enrolled, as were 19,827 practitioners (some participated in multiple studies), plus electronic records for 790,493 patients in two data-only studies. To date, these studies have led to 193 peer-reviewed scientific publications in 62 different journals. The mean (1.40) Relative Citation Ratio of Network publications connotes a greater-than-average influence in their fields.
Conclusions:
These metrics demonstrate that the PBRN research context can successfully engage practitioners and patients from diverse settings nationally with a high and sustained level of scientific productivity. This infrastructure has enabled clinical scientists in oral health and nonoral health topics and provided additional recruitment venues outside of the typical academic health center research context.
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