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Performance measurement leads to quality improvement, because performance measurement can identify areas of vulnerability to guide quality improvement activities. Recommendations from empirical institutional review board (IRB) performance measurement data on research approval criteria, expedited review protocols, exempt protocols, and IRB continuing review requirements published over the past 10 years are reviewed here to improve the quality and efficiency of IRBs. Implementation of these recommendations should result in improvements that can be evaluated by follow-up performance measurements.

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

In 2007, Taylor proposed to move beyond compliance to develop measures for assessing the ethical quality of institutional review board (IRB) reviews. To date, no such tool has been developed. In 2018, Lynch et al. proposed to move beyond quality to advance effective research ethics oversight. Instead of providing a set of measures, they proposed to define and specify ways to measure the effectiveness of IRBs in protecting human subjects. They further claimed that any attempts to measure the quality and performance of IRBs without using such measures, to be developed by them in the unforeseeable future, were not helpful. The realities are that nearly 50 years after its establishment, there has been no systematic assessment of the quality and performance of IRBs, and that nearly two decades after the deaths of Jesse Gelsinger and Ellen Roche and the implementation of reform processes to improve our system of protecting human subjects, there is still plenty of room for improvement. The challenges today are for Taylor to come up with a tool to measure the ethical quality of IRB reviews, for Lynch et al. to develop measures for assessing the effectiveness of IRBs in protecting human subjects, and for the IRB community to decide whether to continue to wait for Taylor and Lynch et al. to develop their promised tools or to start taking advantage of performance measurements to improve the quality and performance of IRBs by using existing IRB performance metrics or to improve those existing performance metrics.

We analyzed human research protection program performance metric data of all Department of Veterans Affairs research facilities obtained from 2010 to 2016. Among a total of 25 performance metrics, 21 (84%) showed improvement, four (16%) remained unchanged, and none deteriorated during the study period. The overall improvement from these 21 performance metrics was 81.1% ± 18.7% (mean ± SD), with a range of 30% to 100%. The four performance metrics that did not show improvement all had initial noncompliance/incidence rates of

Despite the importance of institutional review boards (IRBs) in protecting human subjects participating in research and the well-known benefits of performance measurements, there has been no systematic assessment of the quality and performance of IRBs. The IRB community has frequently cited the lack of credible metrics for measuring human subject protections and the quality of IRB ethics reviews as reasons for not measuring the quality and performance of IRBs. However, the IRB, with its well-defined missions, functions, structure, and procedures, should be readily amendable to performance measurements. In this brief commentary, I analyzed potential barriers for measuring the quality of IRBs and proposed ways to overcome these barriers.

We compared the human research Protection Program (HRPP) quality indicator data of the Department of Veterans Affairs (VA) facilities using their own VA institutional review boards (IRBs) with those using affiliated university IRBs. From a total of 25 performance metrics, 13 did not demonstrate statistically significant differences, while 12 reached statistically significance differences. Among the 12 with statistically significant differences, facilities using their own VA IRBs performed better on four of the metrics, while facilities using affiliate IRBs performed better on eight. However, the absolute difference was small (0.2–2.7%) in all instances, suggesting that they were of no practical significance. We conclude that it is acceptable for facilities to use their own VA IRBs or affiliated university IRBs as their IRBs of record.