With 37 relying sites and nine active studies, all within 1.5 years since inception, the University of Miami’s new central IRB was a success.
Its mean turnaround time for initial submissions is 34.3 days, and it takes 12 days on average for follow-up submissions.1 A survey of stakeholders showed positive reception.
As the new Common Rule requires IRBs to rely on central IRBs or become a central IRB for multisite studies, some research programs might think it is easier to cede the responsibility. But if they would prefer to build a central IRB, at least one research office director says it is not as challenging as they might think.
“The review part for a central IRB is the same as for a single IRB,” says Evelyne Bital, MA, CIP, associate director of privacy and regulatory affairs for the human subject research office at the University of Miami.
“The challenging part was being able to customize the process to fit the system we had before,” Bital says.
“We have four IRBs and added a central IRB that is dedicated for review of multisite studies,” she adds. “We call it UM Central IRB.”
Bital outlines how the organization created a central IRB from scratch:
• Investigator buy-in. At the University of Miami, investigators came up with the idea of the central IRB.
“They were interested in using a single IRB to serve the research consortia that we were involved in,” Bital says. “At the same time, we were anticipating the change in NIH award policy to do multisite research.”
Taking the investigators’ request into consideration, they began to look into what it would take to become an IRB of record. It seemed to be a good fit when a couple of investigators that were part of research consortia that used multiple IRBs to review its studies decided they needed a single IRB, she explains.
“They approached us and we considered,” Bital says. “After that, we saw that NIH was looking at changing their policy.”
So in 2016, the IRB decided to become the central IRB for one multisite study.
• Hire staff and create a new board. “We had limited ability to hire, so we assigned experienced staff members to do this work,” Bital says.
The next question was: “Do we have a separate IRB doing it, or do we incorporate the team we already have?” The answer was to create a separate board for the central IRB work, she says.
“It started with one experienced staff member in the office, dedicated for that purpose,” Bital says. “It was me, and I was overseeing the program and had one regulatory staff person running the board — someone who was already in the office and was experienced in doing work we’ve done here.”
• Use a coordinating center. The study reviewed by the new central IRB had a coordinating center, because it was part of the big consortia, Bital notes.
“We work with that coordinating center to put everything together, and that’s one of the criteria we have: We require that each study has a coordinating center to communicate with the different sites,” she says.
Without a coordinating center, a study with 200 sites would not be feasible, Bital adds.
“For that first study with almost 200 sites across the United States, we work closely with the coordinating center to put everything together,” she says.
• Create institutional authorization agreements. Selecting the exact language of these agreements takes time.
“There’s a lot of back and forth to come up with the language that they would agree with,” Bital says. “The first agreement took months to finalize, but now I can say it takes a week to do an agreement because we can take language from the different sites and come up with an institutional authorization agreement that everyone agrees with. They might want to add something, but it’s easier now.”
It also helps to use the free SMART IRB platform, she says. It supports single IRB review and helps organizations with the NIH’s single IRB review policy. SMART IRB also has templates, checklists, standard operating procedures, and the online reliance system that makes it possible for institutions to request, track, and document reliance agreements for each study, she says.
• Customize all processes. “Say your system is designed for research at one site, and you’re sending letters to one site,” Bital says.
Then the IRB is a central IRB that has 20 sites — all of which will need letters and have documents to approve and upload. “It becomes difficult when your system was not built for that,” she explains.
“We had to customize a lot of the work we normally do in the system,” Bital says. “We had to speak to our research IT department and work very closely with them.”
This involved uploading letters, compressing documents to save space, and working with the electronic system vendor to tailor a process to multisite research.
• Split determination. “Another issue we found was split determination, which is different from the regular IRB review for one study,” Bital says.
This occurred because the central IRB took on the role of IRB of record after each research site’s IRB already approved the protocol. The new central IRB reviewed these protocols separately, but the central IRB could not approve all of the protocols because some lacked important information, and this resulted in a split determination, Bital explains.
“We had the split determination during the meeting, so the letters sent out to each site were different,” she says. “In the future, everyone will follow the main site’s protocol.”
• Handle requests. “The authorization agreement says who does what and how communication is going to flow, so it’s clear to everyone,” Bital says.
Sometimes, one site will want to do things one way and another site will want to do things another way, and these differences are discussed at the central IRB’s meeting, which will provide its determination, she says.
• Finding staff and board members. “We started with someone who was experienced in our office and we knew was capable of reviewing this type of study,” Bital says. “He started with the IRB and then we onboarded two more people within a few months.”
Board members for the central IRB were members of the other IRBs, as well as a few new board members. Everyone has IRB experience.
Meetings can last five hours, discussing only two items on the budget, but each item takes a very long time because the board will look at every research site, she says.
• Consider different state laws. One of the time-consuming aspects of multisite protocol reviews is local context. This often includes state laws that go above and beyond federal human research protection. One state might adhere precisely to federal law on handling research involving children, for example. Another state will ask that particular rules be followed beyond what the federal requirements are. When a central IRB reviews a multisite, multistate study, it must consider the individual state laws for each site.
“You have to see if the language the research institution wants in its informed consent conforms with each state’s law,” Bital says.
“That’s why we have a form when we start the process of review with a state, and we provide the site with a local context form where they can give us all of their local context information and what they want to see on their consent form,” she explains. “When we review the study, we see all of these documents and we ensure this information is in the consent form and that it is reviewed by the board.”