Avoid mission creep, blurred boundaries for IRB
Avoid mission creep, blurred boundaries for IRB
Worry less about liability
An IRB expert makes the case that an IRB can improve its quality by working smartly with data safety monitoring boards (DSMBs), rather than sliding into their jurisdiction.
"There's been a tremendous amount of mission creep between both boards," says Stephanie J. Zafonte, MSN, RN, CCRP, CQA, RAC, director of operations at George Washington University, biostatistic center, in Rockville, MD.
"IRBs are concerned that they need to see every event that happens if it might impact a study," Zafonte says. "However, when they're looking at events individually they don't get the context of what it means for the overall study."
Zafonte produced a poster abstract that was submitted to national human subjects research conferences last year. It was about how DSMB plans can alleviate IRB burden. She also has worked as senior extramural regulatory analyst for the office of clinical research at the National Heart, Lung and Blood Institute of the National Institutes of Health in Bethesda, MD.
DSMBs also have experienced the mission creep of being expected to review feasibility and performance metrics that really start to push the boundaries of what they should be reviewing, she adds.
"So you have the overlapping gray area of everybody wanting to see more information data," Zafonte says.
Every protocol has a data safety monitoring plan, so what the industry should do is strengthen those plans and delineate the responsibilities of the DSMB and the IRB, she suggests.
"Then we build trust between the groups and cut down on mission creep," Zafonte adds. "The IRBs have a mission of looking at the big picture, and they don't have time to look at every serious adverse event (SAE) that comes along for a protocol."
The DSMB has the context of looking at trends in a study's SAEs, so the IRB would be smart to listen to what the DSMB has to say about unexpected events rather than making their own decision based on limited data, she says.
"Everybody thinks they're liable, and so they need to look at every aspect of the trial," Zafonte says. "So we're becoming counterproductive, and the approval processes become so overburdened, and IRBs are overworked."
What should be happening is the DSMB should be assigned the role of looking at unanticipated events, and the research organization should develop a plan of what should be reported, she adds.
"We need to stop with the mentality of 'If I don't know what to do then I'll report it,'" Zafonte says.
"We have the mentality that over-reporting is better than under-reporting, and what has happened is that it's almost impossible for IRBs to distinguish the important events among all the noise they're getting," Zafonte says.
IRBs should say they don't need to see every SAE that comes along, but that they want to see the DSMB's assessment of the impact of those events, Zafonte says.
Put the burden on the DSMB instead of the IRB.
Likewise, the DSMB should accept from the start that the protocol is scientifically strong and was adequately reviewed by the IRB from a human subjects protection perspective, Zafonte says.
And the research organization should focus on strong data safety monitoring plans, strengthening the process whenever possible, she adds.
"I recently did a review of several hundred protocols coming through the review cycle at NIH," she says. "I found it very upsetting that those DSMB plans were very short or brief or nonexistent."
Having a strong data safety monitoring plan helps to make the system stronger and less burdened, Zafonte says.
An IRB expert makes the case that an IRB can improve its quality by working smartly with data safety monitoring boards (DSMBs), rather than sliding into their jurisdiction.Subscribe Now for Access
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