Examples of central IRB models
IRBs could be working with any and all
Working with different central IRBs and using different models has created some confusion for local IRBs, experts say.
Each central IRB has its own model for working with local ethics boards, says James Riddle, MCSE, CIP, CPIA, assistant director of Fred Hutchinson Cancer Research Center in Seattle.
For instance, a research institution might be working with central IRBs that have one of these different models:
• Shared model. "Most institution-based IRBs don’t have the resources to provide all of the same resources as a commercial central IRB, so some of the responsibility is shared," Riddle says.
An example is the Central IRB (CIRB) Initiative formed by the National Cancer Institute. CIRB performs protocol review, amendments, and continuing review, but there also is work done by the local institutional IRB, including preparation of the final informed consent form, Riddle says.
Another shared IRB model, called IRBShare, is where one institution will provide the initial review of a research project. Then other institutions participating in the IRBShare project can rely on the first institution’s review of the protocol as their own, he explains.
"That model, essentially, is sharing the initial review responsibilities, but after the initial review, each institution then conducts local review of amendments, continuing review, reportable events, etc.," he adds.
• Optional lead IRB model. "When Fred Hutchinson serves as the central IRB, we use a model we call the lead IRB," Riddle says. "We use this model for various research networks where Fred Hutchinson is the network coordinating center."
It provides centralized IRB services on a voluntary basis to members of the network. The chief example of this model is the Cancer Immunotherapy Trials Network (CITN), which is located at Fred Hutchinson.
"We are the coordinating center, and all of the participating network sites are offered the opportunity to use the Fred Hutchinson IRB as the IRB of record, or they can use their own local, institutional IRB," Riddle explains. "It’s an optional, centralized IRB — not required."
About half of the CITN sites use Fred Hutchinson IRB as their central IRB, he adds.
With the lead IRB model, the central IRB does all of the IRB-related work, including initial review, modifications, and unanticipated problems reporting. The local IRB does its regular institutional activities, including handling conflicts of interest, Riddle says.
• Mandatory central IRB model. Some federal research grants have required the receiving institution to provide compulsory central IRB review. The compulsory use of central IRBs may become more prevalent as funding agencies require all participating sites to use the central IRB as a condition of the research grant, Riddle says.
"Those are just three examples of central IRB models," he says. "There probably are dozens more that have been springing up as NIH [National Institutes of Health] and other funding agencies have mandated the use of a centralized IRB system." n
