As IRBs begin to increase their reliance on central IRBs or form relationships as the IRB of record, the most important action they can take is to build close relationships and trust with research organizations and researchers, experts say.
“The key is close relationships with the people you’re working with and establishing a trusting relationship with your research staff,” says Cherie Bilbie, MS, CCRP, CIP, director of the human research protection program at Hartford HealthCare in Hartford, CT.
Having templates in place and being well-organized can help build trust, she notes.
“For instance, we have some local partners in Connecticut,” she says.
“We have a template agreement in place, and within that written agreement are steps built into who is responsible for what,” Bilbie says. “We have expectations on each side of the fence outlined so everyone knows their part.”
A large hospital system, Hartford has formed partnerships with a number of smaller healthcare institutions throughout Connecticut. The partnerships resulted in Hartford HealthCare taking on primary IRB review duties, bringing in the smaller hospitals’ IRB staff when possible, Bilbie says.
“Originally, there were four functioning IRBs within a health system,” she says. “But it made sense for us to transfer oversight and take over that function for them.”
The health system has a tertiary care teaching hospital, four community acute care hospitals, two regional behavioral health centers, a home care system, and other healthcare organizations. When hospitals were brought into the health system, the organization established a centralized IRB, applying one set of standard operating procedures and decreasing duplicative reviews.
One of the challenges involves electronic records and connecting other organizations to that record. This works well when a health system brings hospitals on board. For instance, the Hartford HealthCare IRB has access to all research records in which its institutions are involved, Bilbie notes.
“It works for us because it allows the project to enter our tracking system,” Bilbie says. “What our study teams do is rely on our electronic IRB system as a document repository, and it gives us access to all of the approved documents that we’re accepting, and it allows the study team to access those documents.”
The IRB can track financial conflicts of interest, training requirements, and other items to be monitored.
“We won’t accept the review until we check it to make sure everybody is up to date on their requirements,” Bilbie says. “Our internal system allows us to have a gatekeeper.”
Even when a health system’s IRB is relying on another institution, monitoring should still take place, she notes.
“You still have an element of responsibility for what’s going on in your shop, so even if the study team is not submitting progress reports to your office, you need to do your own post-approval monitoring,” Bilbie says. “We have one full-time person to do post-approval monitoring.”
Hartford HealthCare has set up a System Central IRB with its own federalwide assurance to serve as a central IRB for individual committees from three partner institutions. “We put in place an authorization agreement with each of these hospitals,” she says. “It has worked smoothly.”
The central IRB format has made the IRB work much more efficiently, eliminating about 100 duplicative reviews so far, Bilbie says.
“We had some learning curves because we were bringing on the electronic system at the same time,” she adds. “But we did a lot of volume assessment before we made the move, so we knew what we would be taking on if we needed to make adjustments.”
As IRBs begin to increase their reliance on central IRBs or form relationships as the IRB of record, the most important action they can take is to build close relationships and trust with research organizations and researchers, experts say.
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