Ceded review streamlines study approval

Agreement adds to workload but helps IRBs

IRB administrators who use the Harvard Catalyst's ceded review system say it performs as promised — providing a more efficient way for institutions that collaborate frequently to handle multisite studies.

They particularly praise the voluntary nature of the process — an individual institution can choose to cede review to another IRB or not for every protocol — as key to its success.

"What has worked well here is just the philosophy that we can choose to accept or deny a reliance agreement," says Susan Kornetsky, MPH, director of clinical research compliance at Children's Hospital in Boston. "In the end, we have ability to decide if we want to rely or not."

Kornetsky and Leigh Read, CIP, senior research programs administrator at the Joslin Diabetes Center in Boston, serve as gatekeepers for the ceded review requests that come to their respective institutions.

Kornetsky says she receives roughly three to five such requests a month; Read sees them less frequently, about once or twice each quarter.

Both say the requests they often receive are for minimal risk studies — perhaps involving transfers of data or recruiting subjects at one institution for a study being conducted at another.

In those cases, Read and Kornetsky say, they often make the decision of whether to cede themselves.

"It really depends on the type of patient contact," Read says. "If it's a complex study, and patients are being seen here, I may go to my [IRB] chair and to my institutional official and say, 'I've reviewed this, this is what's being done, I recommend we cede or I recommend we do not cede,' and they would make the final decision."

For one study, Kornetsky says, the decision of whether to cede review was actually referred to the IRB itself, because of the intricacies of the study. The board reviewed the proposal and decided to allow the ceded review, but to keep an eye on some aspects of the study internally.

"It was in a very unusual situation, but it worked well," she says.

Administrator burden

Barbara Bierer, MD, director of the regulatory knowledge and support program for the Catalyst, notes that because the IRB administrators must look at all of these ceded review requests to determine how to handle them, it does increase the burden on those administrators.

"One thing we didn't appreciate at first was the fact that you need somebody to take this on as part of their job," Bierer says. "On the other hand, for our IRBs, it's really been an improvement. For the system, it decreases work."

Kornetsky and Read confirm that they've contended with this issue in their own operations. They say the requests from investigators are not always complete or filled out correctly, and they sometimes must take time to track down details about the study before making a decision about how to handle a request.

Turn-around time is also a consideration, Read says.

"When I do get a request in for a ceded review, the investigator usually wants an answer as fast as possible," she says. "So if all of the information is not in the report and we need to ask the investigator questions, and go to the other IRB administrator and say, 'What do you think?' … for me, it does add some extra work. Sometimes I'll have to take the everyday stuff that I've been doing and put it to the side to address [the ceded review request]."

But both she and Kornetsky also agree that the Catalyst's reciprocal reliance agreement has improved efficiency overall in their IRB offices.

"If anything, it's increased my workload, but it certainly has decreased the IRB's workload, and that of the other administrators," Kornetsky says.

Read says the process has benefited investigators at Joslin, who often collaborate with colleagues at other institutions. Joslin is a specialized diabetes clinic; it may lack some equipment necessary for a particular study, so its investigators collaborate with someone at a larger hospital.

"For example, we do some studies here that involve an MRI procedure," Read says. "The only procedure that's going to be done at the larger hospital is the MRI. The majority of the time, the larger hospital will cede review to us for that."

Prior to the reciprocal agreement, she says, the investigator would have to submit the protocol to Joslin and the other hospital for review.

"Both IRBs would review it — we would probably recommend changes, they would probably recommend changes," Read says. "They'd have to submit their changes to us, and we'd have to submit our changes to them.

"It really did make the process of collaboration difficult."

Comfort level

Read and Kornetsky say that since the agreement has been in place, IRBs at all of the institutions have become more comfortable ceding to one another.

"I think in the beginning, people, including ourselves, would not think about this for an interventional trial, some type of drug trial, something done in the hospital," Kornetsky says. "I think people are getting a little more comfortable but are still very careful in deciding when it makes sense [to cede] and when they would rather review it."

She sees this type of arrangement as a good one for any institutions that collaborate frequently.

"If you know you're going to work together a lot and there's a lot of cross-institutional research with the same people, this works well, because you don't have to do an actual reliance form every time," Kornetsky says."

She says the Harvard Catalyst and other partnerships formed around the NIH's Clinical and Translational Science Awards (CTSA) are a natural place for these reciprocal agreements to start.

"Just by the nature of being organized in a CTSA agreement, you're going to be reviewing with the same people frequently," Kornetsky says. "So this would be a perfect solution."

Read says that organizations seeking to create a similar agreement need to make sure all of the pertinent details are nailed down before the process is in use.

"Make sure that you look at everything that may happen and get it into the agreement up front," she says. "Think about what this agreement is for, what it's going to do, and get everything in there, so that it's usable for your investigators, it's clear."

She says it's also important that all of the participating institutions feel that they've had input into the agreement. A process that seems to be driven by the needs of one particular institution won't be as successful.

"When the Catalyst did it, there was really no one institution, that took the lead," Read says. "Yes, there were times when one institution said, 'I want this in it,' but the right people talked it out and got to a point where everyone was comfortable.

"It really has to be a collaborative effort."