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Abstract

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 <1.0%, ranging from 0% to 0.98%. The initial noncompliance/incidence rates of the 21 performance metrics that showed improvement ranged from 0.05% to 60%. However, of the 21 performance metrics that showed improvement, 10 had initial noncompliance/incidence rates of <1.0%, suggesting that improvement could be achieved even with a very low initial noncompliance/incidence rate. We conclude that performance measurement is an effective tool in improving the performance of human research protection programs.

Keywords

human subjects protections human research protection program performance measurement performance metrics institutional review board and quality improvement

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Effectiveness of Human Research Protection Program Performance Measurements

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