WIRB-Copernicus Group Reveals Results from 2015 Institutional Review Board (IRB) Performance Report
Comprehensive report analyzes data from 131 U.S.-based hospital and university IRBs
PRINCETON, N.J., Dec. 23, 2015 – WIRB-Copernicus Group® (WCG™), the world’s largest provider of regulatory and ethical review services and software to support clinical research, today announced the release of top-level findings from its “Institutional IRB Performance: 2015 Optimizing and Benchmarking Report.”
“As government grants for clinical research continue to decline, institutions are looking to industry to provide the funding necessary to support their clinical research programs,” commented WCG Chairman and Chief Executive Officer Donald A. Deieso, Ph.D. “Institutions recognize that optimizing their performance is critical to becoming a better partner to industry. We are proud to support our institutional clients by providing objective, reliable IRB benchmarks and expert guidance to assist them in their journey of continuous improvement.”
“There are many administrative processes that surround IRB review; if they are inefficient or improperly managed, they can often add significant delays in clinical trials, which ultimately impact the time it takes to deliver new therapies to patients,” added Stuart Horowitz, PhD, MBA, WCG President of Institutions and Institutional Services and one of the report’s authors. “Institutions that are actively working to grow their clinical trial portfolios – and better serve their investigators – are focused on driving measurable and sustainable improvements in the performance of their research oversight function.”
This year’s report features data from 131 institutions (81 hospitals and 50 universities). These institutions are all US-based members of the WCG Global Research Network, and use the IRBNet research compliance platform to support their IRBs and human research protection programs (HRPPs).
The institutions represented in this analysis oversee nearly 32,000 human research protocols led or coordinated by approximately 61,600 investigators and other study team members.
The composition of the research conducted at the hospitals in this report was 83 percent biomedical (23 percent oncology, 60 percent non-oncology) and 17 percent social/behavioral. In contrast, research in the university setting was 77 percent social/behavioral and only 23 percent biomedical (three percent oncology, 20 percent non-oncology).
This report was authored by Dr. Horowitz, a former institutional research official and experienced institutional research consultant; Andrew M. Olmsted, MBA, Executive Vice President of IRBNet and co-founder of the Alliance for Clinical Research Excellence and Safety (ACRES); and Jeffrey A. Cooper, MD, MMM, WCG’s Vice President for Process and Strategic Improvement and a founding member of the Association for Accreditation of Human Research Protection Programs Inc. (AAHRPP).
The experts observe that many institutions have adopted several IRB operating procedures that are not required by the regulations and do not provide additional protections for subjects. They do, however, negatively impact the research program’s performance and create unnecessary delays. Examples include requiring the IRB chair to sign approval documents and requiring a convened IRB to “ratify” review decisions made using the expedited procedure. They also cite lengthy application forms that repeat information already contained within the protocol, and the requirement for an investigator to be present (either in person or via teleconference) at the convened IRB meetings, as additional causes of delay.
The experts encourage institutional research administrators to focus on staffing, training and communication as key areas for improvement. With appropriately trained and mentored staff, the most efficient and effective staffing ratio is considered to be one analytical IRB employee per 300 protocols reviewed. The experts also recommend clearly defining the roles of HRPP employees, because in small institutions, they have a tendency to absorb other non-IRB related tasks, which can distract them and cause IRB delays.
WCG operates five independent IRBs comprised of 14 review panels each individually AAHRPP-accredited. In addition, its Western IRB and Copernicus Group IRB are the only two IRBs to achieve International Organization for Standardization (ISO) 9001:2008 certification, in recognition of their high standards of quality and efficiency. Copernicus Group IRB is also Lean Six Sigma certified.
For additional findings, the 2015 Benchmark Report is available for download at http://www.wcgclinical.com/insights/white-papers/.
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 Protections (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.