WIRB-Copernicus Group Releases Performance Report for the Optimization and Benchmarking of Institutional IRBs

Comprehensive benchmark report aggregates data from 105 U.S.-based hospitals and universities

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Dec 05, 2014, 08:12 ET

PRINCETON, N.J., Dec. 5, 2014 /PRNewswire/ -- WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services and software to support clinical research, today released topline data and recommendations from its "Institutional IRB Performance: 2014 Optimizing and Benchmarking Report."

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WCG Chairman and CEO Donald A. Deieso, PhD, commented, "At WCG, we are committed to continuous improvement, not only for ourselves, but for the industry. Our 2014 Benchmarking and Optimization Report provides hospitals and universities with objective performance data – coupled with optimization strategies from our experts – empowering them to drive a cycle of continuous improvement in the oversight and administration of research."

WCG operates five independent institutional review boards (IRBs) comprised of 14 review panels, each individually-accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). In addition, WCG is the only ethical and regulatory oversight provider to achieve Lean Six Sigma certification and International Organization for Standardization (ISO) 9001:2008 certification, in recognition of its exceptional standards of quality and efficiency.

WCG's Benchmark and Optimization Report aggregates data from 105 U.S.-based institutional IRBs, all of which are members of the WCG Global Research Network (44 universities and 61 hospitals), and rely on the IRBNet platform to support their compliance and research activities. This analysis involved more than 25,000 human research protocols, led or coordinated by about 44,000 investigators and other study team members.

The report authors – IRBNet Executive Vice President Andrew M. Olmsted, MBA; WCG Vice President of Global Consulting Jeffrey A. Cooper, MD, MMM; and WCG President of Institutions and Institutional Services Stuart Horowitz, PhD, MBA – noted that many IRB efficiencies could be gained from improvements in staffing and communication. Their recommendations included ensuring the appropriate headcount of IRB staff (identified at a ratio of approximately one analytical IRB staff person per 300 protocols), with increased focus on their training and mentorship, as well as improving the quality and frequency of communication between IRB staff and investigators.

The data showed that appropriately-trained and empowered IRBs operate both efficiently and effectively. They demonstrate a clear understanding of the regulations and of their mandated duty. The highest performing IRBs avoided unproductive behaviors, such as accepting responsibilities outside of their purview (for example, non-IRB functions such as managing investigator conflict-of-interest, budget and contract review), and creating or following operating procedures not rooted in the regulations (which do not provide additional subject protection).

Drs. Jeffrey A. Cooper and Stuart Horowitz will present additional data from this study at the Public Responsibility in Medicine and Research (PRIM&R) 2014 Advancing Ethical Research Conference in Baltimore, MD on Dec. 7. Their session, entitled, "Institutional IRB Performance: Benchmarking and Optimization," will be held from 9:30-10:45 a.m. ET.

For more information on the PRIM&R 2014 AER Conference, please visit http://www.primr.org/aer14.

About WIRB-Copernicus Group
WIRB-Copernicus Group (WCG) is the world's largest provider of regulatory and ethical solutions for clinical research. The company provides Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) reviews, and Human Research Protection (HRP), Good Clinical Practice (GCP) and Biosafety consulting services. Its technology offerings include IRB workflow management solutions (IRBNet), clinical trial management software for sponsors and contract research organizations (ePharmaSolutions), and Part-11 compliant online learning solutions for research professionals (WCG Academy).

The pioneer of independent ethical oversight, WCG continues to drive progress in the clinical research space. WCG empowers clients to accelerate life-saving advancements, while ensuring that the risks of progress never outweigh the value of human life.

For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.

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