Systems approach to assessing and improving local human research Institutional Review Board performance. Issue 2 (8th August 2018)

• Record Type: Journal Article
• Authors: Fontanesi, John; Magit, Anthony; Ford, Jennifer J.; Nguyen, Han; Firestein, Gary S.
• Is Part Of: Journal of clinical and translational science. Volume 2:Issue 2(2018)
• Page Start: 103
• Page End: 109
• Publication Date: 2018-08-08
• Subjects: Common metrics, -- Institutional Review Board, -- best practices, -- clinical trials, -- quality improvement; Clinical medicine -- Research -- Periodicals; Medicine, Experimental -- Periodicals; Human experimentation in medicine -- Periodicals; 616.027
• DOI: 10.1017/cts.2018.24
• Languages: English
• ISSNs: 2059-8661

Abstract

Abstract : Objective: To quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations. Methods: Over 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies. Results: Staffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process. Conclusions: Understanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics.