Area Hospitals, Universities Collaborate on Clinical Research Review

CINCINNATI—A group of hospitals and research institutions across Cincinnati and Northern Kentucky has formed a collaborative Institutional Review Board (IRB) agreement that will allow any of the six participating sites to serve as the IRB of record for human subjects research conducted across multiple participating study sites.

The new collaborative agreement could increase study enrollment, speed the recruitment process for studies and expand access to clinical trials for people interested in participating.

Participants in the collaborative IRB agreement—all members of the Consortium of Greater Cincinnati IRBs (CGCI)—are Cincinnati Children's Hospital Medical Center, The Jewish Hospital - Mercy Health (serving as the IRB of record for Mercy Health), Northern Kentucky University, St. Elizabeth Healthcare, TriHealth Inc. and the University of Cincinnati (serving as the IRB of record for UC Health.)

IRBs, required for institutions conducting research involving human subjects, are the infrastructure used to protect research study participants. Until now, collaborations across participating institutions locally had required redundant review at each individual institution—a multi-step process that could impede multi-site studies essential to developing new treatments and therapies to improve human health.

The new collaborative agreement reduces redundancies in the review process and has already allowed UC’s IRB to rely on the IRB at TriHealth for approval of a minimal risk study on medical decision making.

UC’s Center for Clinical and Translational Science and Training (CCTST), which, along with the Greater Cincinnati Health Council helped to form CGCI, has experience developing multi-site IRB agreements. In 2012, CCTST leaders worked with partnering institutions in Ohio to develop a statewide process for IRB approval on multi-center trials. More than 25 studies have already passed through this statewide "reliant” IRB.

"It seemed only natural to us that, if we could work out a statewide agreement, we should certainly be able to develop something that will greatly benefit local researchers and patients,” says James Heubi, MD, UC professor of pediatrics, associate dean for clinical and translational research and co-director of CCTST. "This local agreement will reduce the burden on investigators trying to conduct research in multiple locations across Greater Cincinnati and Northern Kentucky, and will also open the door to researchers who may want to start a multi-site study but had been held back by the administrative hurdles.”

The formation of this six-institution collaborative agreement was spearheaded by Michael Linke, PhD, chairman of UC’s IRB and physical scientist at the Cincinnati Department of Veterans Affairs (VA) Medical Center. In summer 2013, Linke was awarded the Greater Cincinnati Health Council’s first-ever Servant Leadership Award for his leadership role with CGCI.

"This collaboration among local hospitals will bring so much benefit to the research community and our region’s patients,” says Craig Brammer, CEO of the Greater Cincinnati Health Council, the Health Collaborative and HealthBridge, and field service assistant professor in the family and community medicine department at UC. "We applaud Mike’s leadership in bringing together so many organizations with different processes and creating a shared vision for moving the collaborative IRB process forward.

"Our region is now truly ahead of the curve with regard to infrastructure for conducting clinical research.”

CGCI, formed in 2011, developed out of the Community-wide Institutional Review Board Workgroup, which was created in 2010 by the Greater Cincinnati Health Council and UC’s CCTST to address region-wide research issues. CGCI’s mission is to promote efficient and ethical review of human subjects research by IRBs in the Greater Cincinnati Region.

The University of Cincinnati’s CCTST serves as a research resource and "academic home” for clinical and translational scientists and programs. Working through support by the National Institutes of Health’s Clinical and Translational Science Awards program, CCTST serves to bring innovations from the laboratory bench to the bedside and to applications within the community. Institutional partners include Cincinnati Children’s, the Cincinnati VA Medical Center and UC Health.

The Greater Cincinnati Health Council is a widely recognized association that provides a unique forum where hospital and health care leaders connect to create a stronger health care community. For more than 50 years, the Council has served as a trusted voice on hospital and health care issues for the Tristate region.