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 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 interested patients.
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 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 already has 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 already have 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,” said James Heubi, M.D., 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, Ph.D., chairman of UC’s IRB and physical scientist at the Cincinnati Department of Veterans Affairs (VA) Medical Center.
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 subject research by IRBs in the Greater Cincinnati Region.
The University of Cincinnati’s CCTST is a research resource and “academic home” for clinical and translational scientists and programs. Working through support by the NIH’s Clinical and Translational Science Awards program, CCTST works 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.