Ped researchers, IRBs building networks
Network tracks PIs' protocol submissions
When a research network sets out to conduct multisite trials, IRBs can sometimes be seen as an obstacle that must be overcome. But the Pediatric Emergency Care Applied Research Network (PECARN) took a different approach, setting up performance goals for investigators and encouraging them to develop ties with their IRBs.
The result has been a significant improvement in the network's operations, says Rachel Stanley, MD, assistant professor of emergency medicine at the University of Michigan in Ann Arbor and formerly chairwoman of PECARN's quality assurance subcommittee.1
Stanley says the cooperative relationship with IRBs was particularly important as PECARN navigated its first uses of the emergency exception from informed consent (EFIC) within the network.
"I think we've had some really positive interactions with IRBs and seen that local communication is really important," she says. "We felt that we managed to work really well with the IRBs just because of the local conversation that goes on and because of our performance measures."
PECARN is made up of 22 emergency department sites across the country and a data coordinating center. The sites are organized into four nodes; Stanley is currently the principal investigator for one of those nodes.
PECARN conducts multicenter trials into the prevention and management of acute illnesses and injuries in children. Stanley says investigators across the network actually help develop protocols and vote on which ones would be feasible for PECARN to undertake; studies can take a year or longer to be developed.
When the network began nearly a decade ago, many of the sites involved hadn't done a lot of research before, Stanley says.
"There were varying levels of expertise with research both at the site investigator level and at the IRB level for reviewing projects," she says.
As a result, even when protocols were sent to every site at the same time, some would get IRB approval within weeks, while others could take months.
"We heard lots of different reasons about why that was, and none of them were, 'I didn't submit it on time,'" Stanley says.
Tracking performance of the sites
Stanley says her group was interested in tracking the performance of different sites, in order to identify those who needed extra help. So PECARN began tracking the time it took from release of the protocol to all the various sites until the investigator submitted it to his or her IRB.
"When we made site investigators responsible for submitting an application to the IRB within a 21-day time frame, we found that the issues on the site investigator end went away," she says.
The network also maintains an online steering committee records center, which keeps copies of applications, renewals, amendments, and IRB approval letters.
"You can go back on a study-by-study basis and see on a site-by-site basis how long this one took or how long that one took," she says.
While tracking performance, PECARN also encouraged its investigators to establish close ties with IRBs, particularly the panel chairs.
"Most of the site investigators are fairly well respected members of either that emergency department or that site," Stanley says. "It was the site investigators who were presenting information to the IRB, so that made a difference, approaching IRBs at the local level."
If problems with slow approvals arose, investigators would talk to the IRBs to iron them out, she says. "We would say to [the IRB], 'We're measured by our performance and your performance is part of our performance,'" Stanley says. "We'd let them know that, and they were very responsive to that in a good way."
Dealing with EFIC
At first, she says, some IRBs would want to make changes to protocols, but PECARN's leaders were determined to keep protocols consistent from site to site.
"If a site can't follow that protocol, then they might not be able to be part of that particular study," she says.
However, Stanley says there is leeway in tailoring informed consent to individual sites.
"Obviously, each IRB has individual language they want in their consent form," she says. "For one thing, age of assent is different at different sites. But the basic elements need to be there."
One factor in emergency pediatric research that IRBs and investigators must contend with is the exception from informed consent (EFIC), which provides a way for investigators to conduct studies in emergency settings where obtaining traditional informed consent may be impractical.
Community consultation is a required element of EFIC, and Stanley says she had several face-to-face talks with her IRB at the University of Michigan regarding how best to carry out that consultation.
"They really helped us, and we helped them understand the whole process," she says.
In fact, the University of Michigan IRB created a separate advisory committee to work with the study team on the issue. Michael Geisser, PhD, a member of the IRB who chaired the advisory committee, says his group offered suggestions about how to get the word out.
Both he and Stanley say that traditional focus groups were not successful in garnering much interest. Instead, Stanley says, her team took information to mothers groups and other local organizations in Ann Arbor. Geisser says his committee also suggested using the city's community television service.
"Our role initially [in dealing with community consultation] is just advisory and then the IRB says yea or nay," Geisser says. "But we try to smooth that process by having IRB representation on the consultative committee."
He says PECARN's collaborative work with that committee and with the IRB in general was a real advantage in helping the IRB understand studies and review them efficiently.
"It helps the IRB to understand what's going on in the research and to understand the protocol rationale much better than we normally would just get an application in through the system."
Reference
- Stanley R, Lillis KA, Zuspan SJ, et al. Development and implementation of a performance measure tool in an academic pediatric research network. Contemp Clin Trials 2010 May 15 Epub.
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