Major Ohio research institutions create nation's first CTSA IRB collaboration

Collaboration could enhance biotech growth in state

Three large Ohio academic Clinical and Translational Science Award (CTSA) institutions recently formed an IRB collaboration to allow a central IRB review during multisite studies. This was the first time CTSAs collaborated in this way, and it could serve as a best practice for other research institutions and CTSAs, experts say.

Case Western Reserve University in Cleveland, the Ohio State University in Columbus, and the University of Cincinnati agreed to allow one institution's IRB to conduct human subjects research reviews for other institutions during some multisite studies.

"We wanted to create a clinical research powerhouse so companies or the National Institutes of Health or research organizations could come in and assess how many patients were available for a study, and we could rapidly get things up and running on the IRB," says Pamela B. Davis, MD, PHD, dean and vice president for medical affairs and Arline and Curtis Garvin research professor at Case Western Reserve University School of Medicine.

The IRB review collaboration could pave the way to far bigger research gains across Ohio by providing greater speed and efficiency in multisite study reviews, says Charles Lockwood, MD, dean of the Ohio State University College of Medicine.

"By lowering the barriers of entry, it might generate significantly greater numbers of grants," Lockwood says. "It will be a very powerful tool for obtaining external funding and generating more internal funding, as well."

Ohio research institutions and state leaders have worked to increase the volume of research to enhance its already robust clinical trial and grant economic stimulus, he adds.

"The number of people employed due to clinical trials in the state is around 80,000, a substantial number," Lockwood says. "We have $850 million a year in funding for clinical trials in the state, and there are an estimated 4,000 current clinical trials statewide."

Research is becoming an economic engine for Ohio, which traditionally has been an agricultural and manufacturing state.

"It's also generating knowledge and creating the ability to ensure that critical masses of investigators are present in various state facilities, and with that comes the additional abilities to recruit additional people and create more research potential," Lockwood says. "This allows the state to generate biotech as a significant source of growth and then develop our own biotech companies."

The three Ohio institutions do the majority of research in the state. Their CTSAs expect them to network, and the collaboration is a good example of their working well together, says Thomas Boat, MD, vice president for health affairs and dean of the University of Cincinnati College of Medicine.

"This is probably a really good example of how institutions can work together to facilitate clinical research," Boat says. "You need a big patient population for clinical research, so getting multiple institutions involved is important and mandatory for certain kinds of studies."

Another benefit is that the collaborative agreement could serve as a model for CTSAs in other states, and the action could result in high marks when each of the three CTSAs comes up for renewal, Boat suggests.

"This opens up our investigators to access at clinical trials in other institutions, and vice versa," he adds. "We could develop a broader array of clinical research activities at our institution."

The idea of a collaborative agreement was initiated more than a year ago, Davis notes.

One key to its success was the investment in an electronic hub that expedites the IRB review process by making it easier to transfer large documents, she says.

"When we first developed a facilitated review, we discovered part of the delay was in sending documents because they are so big and when they're downloaded they can get into a clogged system," she explains.

With the hub, the documents are more easily downloaded in the right format, and IRBs can work more quickly to process the information.

"It incrementally speeded it up," Davis says.

"We went to the state and were challenged by the governor to leverage the power of CTSAs across the state, and this seemed an obvious opportunity," she says. "At a meeting with the governor in August 2011, the CTSAs spoke up and said, 'We have a great infrastructure, and we think we could work together,' and the governor said, 'Come back to me and show me how you can do it,' and so we did."

"We started doing facilitated reviews across the state and then thought, 'Why stop at facilitated?'" Davis recalls.

The Endocrine Society of Chevy Chase, MD, heralded the Ohio CTSA collaboration, saying it fit in well with the society's 2011 position statement on the use of central IRBs (CIRBs).

"In an effort to streamline the IRB approval process for endocrine-related studies and others, improve consistency, and assure accountability, the use of central IRBs has been suggested for multicenter clinical research studies," the Endocrine Society's position paper of June 2011 states.

"The Society strongly encourages the utilization of CIRBs for multicenter clinical studies in order to advance clinical research and improve patient care while maintaining the highest patient safety standards," the position statement says.

The Office for Human Research Protection (OHRP) also endorsed the idea of using a single central IRB for multicenter research in a letter written to Carolinas Medical Center of Charlotte, NC, on April 30, 2010: "I want to assure you that the Office for Human Research Protections fully agrees with FDA's position on the benefits of relying on a single central IRB for multicenter research," writes Jerry Menikoff, MD, JD, director of OHRP.

Collaborations that produce a central IRB for review of multisite studies also fit in with accreditation goals, says Boat, who is a past president of the board of the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

As a member of AAHRPP's board, Boat has worked to find ways to enhance research without throwing up obstacles. The collaboration fits that philosophy, he says.

"What's clear is that at research-intensive institutions, IRBs have a huge load put on them," Boat says. "This will reduce the work, create better efficiencies, and probably allow one institution to more thoughtfully look at all dimensions of a study and share the outcome of that process with other institutions."

The collaboration was embraced by each institution's IRB, researchers, and others, Boat, Lockwood, and Davis say.

"Everybody locally and across the state I have talked to has been uniformly enthusiastic and laudatory about this," Boat says.

Small hospitals in Ohio already have contacted Case Western Reserve about joining the collaboration, Davis says.

"The first requirement is that all the IRBs be accredited by AAHRPP, which elevates the IRB to the level of meeting certain standards," she adds. "I'm very enthusiastic about the potential; this is one example of the potential of CTSAs to change how we do clinical and translational research, and the public should know the academic community is working hard to bring new drugs, new therapies, and new strategies to them as quickly as possible and without sacrificing protection."

While each institution will retain the right to have a local IRB review whenever it finds a study to be particularly complex or for other reasons, there likely will be a great deal of shared study review, according to the three university deans.

Since this more efficient IRB review process will free time in each of the universities' IRB offices, there is the potential for taking on more research reviews and work, they say.

"We anticipate more business," Lockwood says. "I see this kind of arrangement as being critical to going forward."

The three Ohio CTSAs have taken a good step toward reducing the energy barriers to doing multicenter studies, he says.

"If we really want there to be greater collaboration from Cleveland to Cincinnati and including Columbus, Dayton, and Toledo, and other schools, then we need to do more and do more together," Lockwood says.

IRBs work hard and often put up with backlogs. The collaboration will help them clear their agendas and become more efficient in reviewing protocols and reducing study delays, Davis says.

"Having a uniform set of expectations and guidelines puts the state in the right direction and allowed Ohio to put together this IRB," Boat says. "This will enhance the overall number of studies done, but hopefully it also will allow us to do more studies without spending a lot more money or wasting IRB members' time."