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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 costprohibitive 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 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.
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.