Effectiveness of Human Research Protection Program Performance Measurements

• Published in: Journal of empirical research on human research ethics Vol. 12; no. 4; pp. 217 - 228
• Main Authors: Tsan, Min-Fu, Nguyen, Yen
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA Sage Publications, Ltd 01.10.2017; SAGE Publications; Sage Publications Ltd
• Subjects: Adult; Business metrics; Child; Ethics Committees, Research; Ethics, Research; Guideline Adherence; Human Experimentation - ethics; Human subjects; Humans; Incidence; Informed Consent; Insurance, Health; IRBs, RECs and Animal Research Ethics Committees/IACUCs; Laboratories; Noncompliance; Performance evaluation; Program Evaluation - methods; Program Evaluation - standards; Quality control; Quality Improvement; Research centers; United States; United States Department of Veterans Affairs; United States > US; human subjects protections; and quality improvement; performance metrics; human research protection program; institutional review board; performance measurement
• ISSN: 1556-2646; 1556-2654; 1556-2654
• DOI: 10.1177/1556264617720387

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.