Table 1.
IRB Metrics structure-process-outcome model used at FTM-EC.
Table 2.
Evaluation of Structure – IRB composition and qualifications.
Figure 1.
Evaluation of Structure – IRB workload & number of protocols/documents reviewed, 2010–2013.
Figure 2.
Evaluation of Structure – IRB workload & different types of new non-exempt protocol reviews, 2010–2013.
Table 3.
Evaluation of Process – Timeliness of protocol review, 2010–2013.
Figure 3.
Evaluation of Outcome - Decision on new non-exempt and continuing/amended protocols reviewed by FTM-EC, 2010–2013.
Note: Excludes 7 studies that are pending decision outcome at data cutoff, and 13 studies withdrawn by PI (for various reasons) or by EC (due to long non-response period).
Table 4.
Evaluation of Outcomes - Ethical issues notified to researcher.
Table 5.
Effects of issues reviewed and notified for revision on “above target duration” in total time from submission to final approval (>60 days).
Table 6.
Benchmarking FTM-EC performance with selected indicators from AAHRPP-accredited institutes, 2012.