Wisconsin’s consortium serves as role model for IRB collaboration

Developing trust is challenge

As more research institutions develop collaborations to share IRB reviews, they may find that developing trust is one of the most important and most challenging first steps.

That was part of the wisdom some experts gained from the experience of developing an IRB consortium of different research entities.

“It took time for the institutions and IRBs to get to know each other as individuals and to learn how each operates and what their orientation is,” 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. Two of the institutions have Clinical Translational & Science Award (CTSA) programs. The Wisconsin IRB Consortium (WIC) was launched in January 2009 to allow a central IRB to review multisite research. With several years of work and outcomes available, WIC is a good model for future IRB and CTSA collaborations. The more recently announced CTSA collaboration in Ohio includes major research institutions in Cincinnati, Columbus, and Cleveland, making it potentially a bigger collaboration than WIC, although it is still in its infancy.

“Once we got to know one another we had a greater comfort level,” Cobb says. “We could say, ‘Yes, they take research protection as seriously as we do and are as knowledgeable, so even if we disagree on some things, we can accept that what you are doing is what you think is right.’”

Building this trust is work. The Wisconsin IRB Consortium built trust through monthly telephone calls, face-to-face meetings, and other discussions between institutions.

“Every time we talk about WIC we say you have to put in face time,” says Carol Pech, PhD, associate director of the health sciences IRB office at the University of Wisconsin–Madison.

“You can’t just [build trust] by email or a couple of phone calls,” Pech adds. “Having meetings is really helpful just to get to know each other and how operations work.”

It’s also necessary to be transparent about processes and concerns.

“Every institution has things that are particularly important or peculiar to their institution, and that makes them hesitant to cede oversight to another IRB,” Pech explains. “So having those conversations in person over a period of time is necessary.”

Another strategy for building trust involves taking time to learn how each IRB conducts its reviews.

“We did a policy review for each IRB, divided by topics,” Pech says. “We looked at the policies involving children, going down the line to see if there were major gaps we needed to address or things to work around, and that took some time to do that kind of review and gap analysis.”

Compromises are necessary. Institutional officials who are starting an IRB consortium could begin with what Pech calls the lowest common denominator approach, as a first big compromise.

For instance, rather than ask each IRB signing the agreement to have a shared conflicts of interest policy, the consortium could leave those guidelines to each institution, she explains.

“We can tweak things as we go and build out the process as we go along,” Pech says. “We’re all committed to having a single agreement and just need to know what those basic pieces were.”

The key is to start the agreement at a point where all parties feel comfortable, she adds.

The WIC also expects its member institutions to be accredited or, at least, have the policies and procedures in place that could result in accreditation, Cobb notes.

While the fact that an institution was accredited wasn’t enough to engender total trust, it is one step an IRB could take to demonstrate that it follows stringent guidelines and is worthy of trust.

One member of WIC is not accredited, but the research staff thinks highly of the institution’s research skills.

“It takes some time for institutions to become accredited,” Cobb says. “We went through all of the institution’s processes and standard operating procedures.”

As future research institutions join the WIC, it’s likely they will need to be accredited, she adds.

“We have gotten to the point where we would expect anyone joining it to be accredited,” Cobb says. “It takes some time for institutions to do that.”

One of the chief benefits of the consortium from the research institution’s perspective is how it provides access to a more diverse patient population, 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. Sorkness also is a researcher and has used the WIC for some studies.

“From my perspective, whenever you’re trying to get universities, organizations, and health care systems to collaborate where they really didn’t before, they should remember that it’s all about the health care delivery system and its ability to attract patients,” Sorkness explains.

The consortium has helped expand multisite research, encouraging investigators to broaden their scope, Pech says.

“I’ve had researchers come in and say, ‘I want to do this study with one of the WIC sites,’ and I say, ‘Do you know these other institutions are part of this consortium, too?’” Pech says. “And it turns out they didn’t know and so then they are willing to expand to another site or two.”

Collaboration is good for health care and research business, and it can be done in the context of respect for the culture and history of individual IRBs and institutions, she adds.

Since WIC was founded four years ago, there have been more than 100 studies that have gone through the central IRB process.

“As time went on, each study review got a little bit easier,” Sorkness says.