In August 2011, Governor John Kasich and JobsOhio head Mark Kvamme convened a meeting in Columbus that included Medical School Deans Pamela Davis, MD, (CWRU), Steven Gabbe, MD, (The Ohio State University), Thomas Boat, MD, (University of Cincinnati) along with senior representatives from University Hospitals Case Medical Center, Cleveland Clinic, University of Cincinnati Hospitals, Cincinnati Children's Hospital and Nationwide Children's Hospital. The general agenda was to develop programs that capitalize on the healthcare and medical strengths in the State to catalyze industry interest in the state and to create jobs.

Among other proposals, the Governor is interested in engaging the three CTSA institutions to develop Ohio as an attractive site for clinical research. It is believed such collaboration would attract pharmaceutical and device industries on a larger scale than currently exists to conduct clinical trials and generate additional research funding to the CTSA institutions. The Deans and Hospital Administrators who were present at the meeting strongly endorsed this plan. Dean Davis was asked to organize this activity.

The next step was to coordinate the research regulatory activities statewide and Dean Davis invited myself, as Director of the Regulatory Core of the Cleveland CTSC, to organize the regulatory parties at these institutions to create the underlying infrastructure necessary to build a statewide clinical research network among these institutions. The initial step was to gauge the interest of the other participants in the state toward an IRB facilitated review model through the use of an electronic document storage hub that was created among the Cleveland CTSC institutions. The IRBs that are part of the CTSC at Case Western Reserve University all have bilateral inter-institutional agreements to reduce the regulatory burden on each individual site for IRB review. An electronic IRB hub, supported by the CTSC, can route a protocol approved by one of the IRBs to any other IRB as desired. The potential for this mechanism to provide appropriate yet rapid IRB review and approval of collaborative research projects is powerful.

The concept of both a clinical trial collaboration throughout the state and a statewide facilitated electronic IRB review system received strong support from the Ohio CTSA organizations. The uniqueness of this program is its novel approach to multi-center IRB review. This is the first effort that we know of that centrally stores information in a cost-effective manner for IRB review. In addition, i it creates additional venues for investigator collaboration, improves access to clinical trials for patients, and reduces regulatory burden. It would be particularly advantageous to connect various like centers and research programs together among the Ohio institutions.

This prompted the creation of an "IRB Facilitation" team within the overall Governor's Charge with the following goals:

1) Provide underlying infrastructure for Human Subjects Protections across the three CTSA sites in the State of Ohio.
2) Enable and enhance collaboration among investigators at each of the CTSA sites
3) Ensure efficiency and reduction of real or perceived regulatory burden for investigators submitting IRB protocols
4) Pilot the electronic facilitated/reliant review hub to determine applicability in broader CTSA consortium venues.

The group met in Columbus in October of this year and to date has accomplished a number of items toward facilitated IRB review among all institutions (read about IRB Facilitation Team accomplishments)

It is believed that the economic impact of this regulatory initiative will have a positive impact on the initiation of more clinical research studies at each institution, that the studies will be initiated faster and therefore more participants enrolled which generates more grant revenues per study, that more patients will travel to Ohio for access to innovative trials not available elsewhere; increase hospital volumes due to increased clinical trial activity; increase opportunities for research coordinator, study nurse and other allied research professional job creation in the state; and finally, increased statewide collaboration that provides additional incentives when recruiting physician investigators to Ohio based institutions.

The CTSC would like to wish Administrative Manager Karen Toil a very happy retirement. Toil began her secretarial career at University Circle in the Geology Department at Case Western Reserve University in 1979, and has since worked at various institutions, including Pediatric Pulmonology at University Hospitals under Dr. Pamela Davis. Toil also worked for 12 years at the Cleveland Clinic's Lerner Research Institute and was an Editorial Assistant for the Journal of Interferon and Cytokine Research for 6 years while serving as Department Coordinator in Immunology at the Clinic. She spent the last 3 years in Administration at the CTSC. An avid dog lover, she will devote volunteer time at the Cleveland Animal Protective League and looks forward to spending time with her 3 grandchildren.

With Karen's departure, the CTSC welcomes Shannon Swiatkowski as the new Administrative Manager (shannon@case.edu). Swiatkowski spent the last 6 years at the Center for Proteomics and Bioinformatics under Dr. Mark Chance. Within the University, Swiatkowski is active in "Case for Community Day", "Introduce a Girl to Science Day", and the activities of the Staff Advisory Council, of which she currently serves as Vice Chair. She received her B.S. in Biology from John Carroll University and M.S. in Pharmacology from CWRU, School of Medicine. She resides in Euclid, OH with her husband, David, daughter Lily (5), and son Adam (4).

Please stop by to bid farewell to Karen and welcome Shannon to the CTSC.