National Children's Study tests shared IRB model
National Children's Study tests shared IRB model
Local sites choose degree of involvement
The first babies brought into the National Children's Study while they were still in utero are now about three years old. And they're not all that's grown.
The project itself — an ambitious long-term observational study that seeks to follow children through age 21 — has enrolled about 7,000 pregnant women at 40 locations across the country, with about 3,000 children enrolled after birth so far, says Steven Hirschfeld, MD, PhD, director of the study. The study, still in its early "vanguard" stage, eventually hopes to enroll 100,000 children, collecting information about environmental and health exposures and other factors that may affect childhood development.
The number of IRBs involved in the project has grown as well, leading to a complex network of institutions that must make decisions about the study and its dozens of amendments. In order to cope with this, the study is testing out a form of multisite review called a federated IRB model.
"We implemented it here in the National Children's Study so that first, we could learn about the model, and second, we could simplify our own human subjects oversight and approval process," Hirschfeld says.
A single study location may involve multiple IRBs. For example, The Children's Hospital of Philadelphia (CHOP) is carrying out the study in a multicounty region around the city. Within that area are at least 16 hospitals where babies are being delivered, and where researchers will go to carry out some of the study activities, such as ultrasounds and cord-blood collection, says Mark Schreiner, MD, chairman of the Committee for the Protection of Human Subjects at CHOP.
IRBs at each of those facilities may have different ideas about the degree to which they are willing to rely on the IRB of record for the study, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) IRB.
"We reviewed the study under expedited procedures," Schreiner says of CHOP. "It's a minimal risk study, it had been through extensive review, it qualified for expedited review."
At many of the hospitals in his region, IRBs insisted on reviewing the study themselves, despite the fact that the Office for Human Research Protections (OHRP) had issued a letter stating that these sites were not engaged in human subjects research.
"The CHOP study team went to those sites and performed all of the procedures," he says. "People at their sites are participating in research, but the research activities are being carried out by the investigators' sites.
"We had some sites that agreed that they were not engaged in research, some sites that allowed us to be their IRB of record, which minimized their burden, and some that insisted on their own review."
A tiered model
Schreiner says he participated in an IRB advisory committee to the National Children's Study once it was underway, and saw some of the effects of this varying IRB involvement.
"Some of these sites were taking all of these things to the full board and were editing the consent form every single time [there was an amendment]," he says. "The burden must have been huge.
"At one of the very first meetings, I said that I didn't think our IRB was adding any value and that we should be able to sign an agreement with the [NICHD] IRB to be the IRB of record. And there was enthusiasm for that idea among the members of that committee."
In response, the National Children's Study set up the federated model. Under this arrangement, IRBs can choose one of three tiers of review for the study:
-Tier 1 institutions agree to rely on the NICHD IRB as the IRB of record, handling all reviews, amendments and adverse event reporting. Thirty-seven percent of the study centers opted to join this tier.
-Tier 2 consists of facilitated review, a shared reliance between the NICHD IRB and local IRBs. Only 9% of study centers have signed up for this type of review.
-Tier 3 is for institutions who want their own IRB to be the IRB of record. More than half the study centers are maintaining local review of the study.
"All of this demonstrates the conservatism of a lot of IRBs," says Schreiner. "I think there is a tremendous reluctance to have cooperative review. People are burdened by this research — here's a minimal risk study with all these amendments and they still think they have something to add to protect subjects. I just find it bewildering."
For his part, Schreiner says CHOP would have joined Tier 1 immediately, but first had to work with the eight sites that were relying on its IRB to get them transitioned to the NICHD IRB as well.
Communication key
In addition to the varying levels of reliance, Hirschfeld says the federated model includes mechanisms for IRBs to communicate with one another, including an operations center where they can download documents and then can upload their own reviews.
"So all the other IRBs know what's going on," he says. "Our goal is to build a trusting community among these other IRBs who otherwise would not have a structured way to communicate."
During the study, an institution can switch from one tier to another, although Hirschfeld says there's been little movement within the federation to date.
He says results are expected later this year from a survey of institutions and researchers about their impressions of the federated model. But he says he's heard informally that the process seems to be working well.
One problem that's surfaced is that minor amendments tend to take longer to get through the system than researchers would like.
"For minor amendments, it takes three weeks, because of the structure and the paper trail that we engage in," Hirschfeld says. "For major amendments, it takes about the same time. But we've reduced by at least an order of magnitude the amount of paperwork and time needed to keep the protocol current. And we've improved the communication, we know that."
He says there are plans to apply this federated model to other projects, including studies within the National Institutes of Health's Clinical and Translational Science Awards.
"The model is adaptable and flexible and is going to be rolled out in other venues in the coming months," Hirschfeld says.
For his part, Schreiner would like to see future projects use models that more strongly encourage participating sites to use a central IRB.
"We've seen a number of NIH grants for research consortia that include a requirement that investigators applying for those grants get a letter from their IRB stating that they would agree to use a central IRB," he says. "That's the way you get people to do it. You have to limit the applications to people who are willing to do that.
"For these huge things, especially if it's a minimal risk study that's been approved by the NIH's IRB, what could we possibly be adding as a site?"
The first babies brought into the National Children's Study while they were still in utero are now about three years old. And they're not all that's grown.Subscribe Now for Access
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