WIC experts on forming an IRB consortium

Know your mission

It’s probably a good idea to expect more obstacles and delays than imagined when initiating a collaboration for conducting central IRB reviews across a region.

Bringing diverse research institutions to the round table also means bringing their cultures and legal offices along, and these add to the challenges of making a true consortium work, experts say.

Here are some of the ways the Wisconsin IRB Consortium succeeded in developing and implementing a central review process:

Decide on a mission or purpose for the consortium: “The Wisconsin IRB Consortium focuses on the most difficult research — investigator-initiated research,” says Nichelle Cobb, PhD, director of the health sciences institutional review boards office at the University of Wisconsin–Madison, which is part of a research consortium that includes Aurora Health Care, Marshfield Clinic, and the Medical College of Wisconsin.

“The consortium came about because the University of Wisconsin wanted to bring mutual research throughout the state to improve the health of Wisconsin residents, and they were trying to groom researchers to do this research,” Cobb explains.

A central IRB model for a regional consortium of medical research organizations can encourage multicenter research that expands its reach across disciplines and across populations, says Chris Sorkness, PharmD, senior associate executive director for the Institute for Clinical and Translational Research (ICTR), a member of the health sciences IRB, and a professor at the University School of Pharmacy and the School of Medicine and Public Health at the University of Wisconsin–Madison.

“Each site has something unique to answer the question best,” Sorkness says. “There’s a value in doing research not simply at the University of Wisconsin, but reaching out to other populations and other clinicians, as well.”

Research consortiums with a central IRB also provide each institution some efficiency benefits, but the bigger picture is how the collaborative effort can benefit an entire state, Sorkness explains.

“The boundaries of the universities are the boundaries of the state,” she says. “What the university does should benefit the entire state, and if you believe in that philosophy then it means that we’re going to try with our CTSA to get more collaboration across our state.”

Better research will result from breaking down institutional barriers, she adds.

Conduct broader research: Having a consortium for multisite research could expand the reach of research, such as asthma studies, Sorkness notes.

“The asthma populations we could reach in Madison are not as broadly represented as we would like them to be,” she says. “With asthma having a greater prevalence and severity in the African-American community, it became obvious to us that we should develop a satellite site in Milwaukee.”

The Milwaukee site could use the same central IRB and the same informed consent forms. Having the two sites, and possibly others, as well, also could enrich the research, Sorkness says.

Investigators could look at environmental influences of asthma in urban versus rural versus suburban communities, she adds.

“The issue of resurgent issues that take populations and investigators from Madison, Milwaukee, and Marshfield to answer questions together enriches research and brings together researchers who might not have worked together before,” Sorkness says.

With the University of Wisconsin CTSA there is a network of researchers that uses the Wisconsin IRB Consortium. Called the Wisconsin Network for Health Research, the network encourages cross-institutional collaboration through funding studies with merit, she says.

“This is important for investigator-initiated research, and it’s at a grassroots level,” Sorkness says.

Focus on training investigators to improve IRB submissions and protocols: Early on, researchers demonstrated a lack of experience in going through the central IRB review process, and their applications were bogged down with problems, Cobb recalls.

“Researchers of the investigator-initiated studies didn’t have the skills set to work with the IRB, and they didn’t know how to write protocols, and there was no existing infrastructure to support them,” Cobb explains.

For instance, investigators would describe the study population and situation at one institution but overlook how the multisite study could have differences at other institutions. Their application and protocol would be incomplete, and the IRB would request the additional information, which slowed down the process, she adds.

“We revised our multisite research page in reaction to that, saying, ‘This is what you have to have in your protocol,’” Cobb says. “There was not enough guidance in writing protocols for multisite studies, so we put guidance on the multisite webpage, including the required elements, what our expectations are, how they can describe activities in the study, and recruiting subjects at each site.”

Researchers who are new to multisite studies still make some mistakes in their IRB review applications, but now they can be emailed guidelines or referred to the website for more information, says Carol Pech, PhD, associate director of the health sciences IRB office at the University of Wisconsin–Madison.

“It’s not uncommon to get a protocol that describes the overall research, but doesn’t describe what is happening at each site,” Pech says. “Those are the nitty-gritty things each IRB wants to know before they decide whether to defer review to the central IRB.”

“Those are the kinds of things we educate study teams about,” she adds. “Researchers who have used WIC before usually have learned what we’re looking for.”

It also was important to train investigators on how to describe different study populations for each site of a multisite study.

Previously, investigators might list their study population as African-American, which would be accurate for one site. But at a second site the population might be Hmong, and this was not disclosed to the central IRB, although it was important information.

“There could be literacy issues with Hmong elderly who were enrolling, and we needed to have someone in place to interview Hmong participants or to be culturally sensitive to it,” Cobb says.

Central coordinators are needed: Investigators are expected to outline how they’ll communicate between research sites, and they must identify a central coordinator at each site.

The Wisconsin Network for Health Research program hired a director to provide coordination and guidance to investigators, Cobb notes.

“They hired a study coordinator for a centralized coordinating center, and they started vetting protocols and sending them through their review to make sure they were adequate,” Cobb explains. “Then they provide feedback on them and do site initiation visits so each site would know how to execute the protocol.”

Each institution in WIC has a designated point-of-contact person. Pech serves as the designated point of contact for the University of Wisconsin. She coordinates group activities and handles all requests that come through her IRB office. She also was involved more heavily with WIC when the consortium was being developed.

“Multisite studies and questions take up a good chunk of my time,” Pech says. “Some weeks it might be over half of my time, but with WIC we also have periods when we don’t have a lot of studies and I’ll just handle inquiries. So it varies.”

Research institutions involved in forming an IRB consortium should be aware that it may require additional staffing or at least some shifts in staff responsibilities.

“I talk to people in other IRB offices and say that it takes time to do this work,” Pech says. “No one has a dedicated person just to do WIC, and that’s one of the challenges we have as a consortium; we could do lots of things but it takes time and effort, and right now we’re all carving this out of our existing positions.”