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Tight ship: CAPTN enlists IRB oversight
Early and frequent collaboration key
When they set out to create a research network to conduct clinical trials in the psychiatric care of children and adolescents, researchers at Duke University's Clinical Research Institute (DCRI) knew IRB issues would play a major role.
Many of the solo-practice psychiatrists recruited to be investigators in the network would have no IRB affiliation. And because of the funding level, working with a large central IRB wasn't possible, says Mark Shapiro, MA, a management consultant specializing in clinical research and drug development who served on the DCRI research team.
"Ultimately, it boiled down to just being cost-prohibitive for the research network," Shapiro says. "The budget for them to review the network probably would have been equal to the entire budget for the network."
So Duke University Health System's IRB agreed to serve as the IRB of record for investigators who needed one, through the use of unaffiliated investigator agreements. Thanks to the IRB's willingness to take on the project, Shapiro says the Child and Adolescent Psychiatry Trials Network (CAPTN) has successfully undertaken multicenter studies of antidepressant safety in pediatric patients, a comparison study of ADHD treatments and other projects.1
Shapiro says one key to the success of the venture was the ability of those creating the network to have multiple face-to-face meetings with IRB officials to work out details. Shapiro says his team probably had about 10 meetings with those officials in the nine months before they got final approval.
"The biggest thing they did to be helpful was that we got face time with the head of the IRB and a couple of his peers," he says. "To basically get a commitment from them that they believed in this research and they would help us work through the kinks in the system. Just getting that support meant a lot."
The structure of the network created some complexities. Duke determined that the individual practice sites would not be added to Duke's Federalwide Assurance (FWA), so the CAPTN project team helped each site file its own FWA. In addition to serving as the IRB of record for the sites, Duke's IRB also was the IRB for the researchers at the CAPTN coordinating center.
"The structures weren't necessarily in place at the time to manage both things independently and you need to treat the coordinating center differently than you'd treat the sites who were participating," Shapiro says. "Each site needs to be looked at as an individual site — is that facility adequate, have they met the requirements from a clinical and clinical research perspective? And for us at the coordinating center, we had different requirements altogether.
"At the time we were doing this, six years ago, these things were very new, the whole concept of doing research networks," he says.
Research ethics training (including human subjects protection training) modules created by Duke's Trent Center for Bioethics, Humanities and the History of Medicine was made freely available to investigators, many of whom had no previous experience with clinical trials. This was provided in addition to NCI training or to training offered by local IRBs, if an investigator was affiliated with an institution that had one.
The nature of the research provides its own challenges. Because the subjects are children and adolescents, studies developed for the network required Subpart D review, a process Shapiro says the Duke IRB has been helpful in facilitating. "They had some clear policies, we made our case, and they eventually did give at least one of our studies a minimal risk designation," he says.
Shapiro says IRBs contemplating such an arrangement should sit down first with those creating a network and discuss its purposes and scope.
"Really the first step is to have a high-level discussion on the aims of the project — what is the clinical setting going to be? What is the funding? What is the network governance going to be like? You want to see credible people running it.
"In that first interaction, the IRB needs to get a sense of whether it's a worthwhile undertaking," he says. "(At Duke), there had to be willingness to do it, to see it as a worthwhile undertaking. Because clearly from their perspective, that's a lot of additional reviews."
He says that now that the network is in place, the time and effort needed from both investigators and the IRB is much less. And while he says every network is different, he thinks the process of creating new networks may be easier now.
"Once we sort of knocked down those doors at Duke, it was probably easier for other folks who came on with other sorts of research networks in other therapeutic areas to create them," Shapiro says.