Three Ohio universities join together to streamline statewide research efforts

A Case Western Reserve initiative to streamline research approvals across the region now extends beyond Northeast Ohio to include the entire state. The effort, which grew from the collaboration the university forged in 2007 to secure a $64 million Clinical and Translational Science Award (CTSA), carries great potential to accelerate medical discoveries and spur economic growth.

“This model is about collaboration for the benefit of patients and society,” said School of Medicine Dean Pamela B. Davis, the principal investigator of the CTSA and the university’s vice president for medical affairs. “Our success in forging an alliance in this area carries great promise for additional cooperative agreements going forward.”

The focus of this first foray into a statewide system involves Institutional Review Boards (IRBs), groups within organizations charged under federal law to evaluate research proposals with regard to such factors as ethical considerations, participant safety and the protection of human subjects in research. While IRBs often require common information, researchers operating at more than one institution traditionally had to complete a separate process for each affiliated review board. The approach significantly hampered the process of multicenter research because scientists had to spend extensive time filling out required documents and responding to questions, and in turn wait for each organization to issue its final decision.

The three hosts of CTSA institutions in Ohio—Case Western Reserve University, University of Cincinnati and The Ohio State University—and their partnering institutions established a statewide agreement allowing one organization’s IRB to assume IRB responsibilities on behalf of multiple institutions when conducting multicenter studies. This is the first reciprocal agreement among multiple CTSA organizations and encompasses eight legally separate institutions in Ohio.

Nearly five years ago the leaders of Case Western Reserve’s collaborative quickly identified the duplicative IRB process as a major hurdle for researchers at every institution. Led by Philip Cola, the vice president for research and technology at University Hospitals, the Northeast Ohio institutions came together to build a process that turned waits that used to stretch weeks or months into ones that take just days. Among the projects that benefited from the model are two studies involving heart failure: one that assesses the potential benefits of a particular enzyme and the other that seeks to identify genetic markers that may presage certain cardiac events. Other projects include one designed to reduce obesity and high blood pressure among Cleveland children and another targeting a rare disease responsible for kidney failure.

Awareness of these successes and existing obstacles persuaded the other two CTSA leaders to sign onto an Ohio-wide model. As The Columbus Dispatch noted recently, a researcher at Ohio State University already saved eight to 10 weeks on his project.

“When a loved one faces a life-threatening illness, time takes on new meaning,” Davis said. “The more we can do to allow researchers to focus on finding answers, the better off we all will be.”

The new cross-state IRB agreement expedites research by allowing all Ohio CTSA researchers to work from the identical trial protocol documentation. Ultimately, it will foster collaborative efforts among investigators, increase efficiency and reduce regulatory burden on researchers.

“This new agreement has already facilitated research planning across Ohio,” said Thomas Boat, M.D., vice president for health affairs and dean of the University of Cincinnati College of Medicine, referring to a partnership between investigators at University of Cincinnati and Case Western Reserve made possible by the new cross-CTSA IRB. Researchers involved will soon begin recruiting patients for a trial on hepatitis A and B vaccine responsiveness in patients with HIV, hepatitis C, or both. “This research partnership is a testament to the speed with which we can get things accomplished—and ultimately benefit patients—with the right processes in place.”

CTSAs were established by the National Institutes of Health to accelerate the process of conducting clinical research and translating it into therapies that benefit human health. Since 2007, Ohio’s three CTSAs have brought in more than $185 million in federal funding to the state.

The participating institutions are Case Western Reserve, the Cleveland Clinic, the Louis Stokes VA Medical Center, MetroHealth, University Hospitals Case Medical Center, the Ohio State University, the University of Cincinnati, Cincinnati Children’s Hospital Medical Center and Nationwide Children’s Hospital.

“By combining the efforts of these research powerhouses, along with the support of the CTSAs, we will make Ohio a premier place for biomedical research and discovery,” said Charles Lockwood, dean of The Ohio State University College of Medicine.