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As IRB workloads shift to summer schedules, it’s a good time to assess whether boards are staying on mission focus, an IRB chair suggests.
“IRBs are charged to evaluate studies under federal regulations; that’s our obligation,” says Jonathan Green, MD, professor of medicine, pathology and immunology, and associate dean for human studies at Washington University and Washington University School of Medicine in St. Louis. Green also is the executive chair of the Washington University IRB.
“It doesn’t mean that IRBs can’t do more, but they have to at least do that,” he adds. “Sometimes through what some call ‘mission creep,’ they do not fully fulfill their obligations.”
Green has one short answer for how IRBs can make sure they stay mission-focused: Review and emphasize the 45CFR 46.111 “Criteria for IRB approval of research.”
“I believe the criteria for approval are necessary and efficient for a study to be reviewed ethically,” Green says.
“IRBs in evaluating studies for approval are evaluating whether those principles are met,” he says. “If a study meets all criteria for approval, then an IRB can be confident it’s an ethical study.”
The reverse also is true, he notes. “With all of the ethical disasters, you can look back and see which criteria they didn’t meet.”
IRB training and continuing education programs should begin with the criteria for review approval, Green suggests.
“This is not intrinsic knowledge that we’re all born with,” he adds.
A first step is to show IRB members how the criteria for approval relate back to core principles.
“We have people go through two-hour training sessions before they can join the committee, and before that they have an online training program,” Green says.
After training, new IRB members observe a meeting and are paired with an experienced reviewer for their first IRB reviews, he adds. “We have an IRB buddy system.”
For each review, IRB members are given a reviewer sheet that explicitly asks them to answer “yes” or “no” for each question in the criteria, Green says.
“Our process is electronic, but you can fit the sheet on one page,” he notes.
The Washington University IRB relies on strong chairs who keep discussions from going off on tangents by asking each time a concern is stated how that concern specifically relates to the criteria for approval, Green explains.
“If it can’t be related to the criteria for approval, then it’s off the table,” he says. “You have to be tactful, saying, ‘That’s a great point; which criteria for approval are you concerned about?’”
One of the causes for mission creep is that people have vague discomfort with certain aspects of a study. But those feelings are not necessarily based on the criteria.
Another step is to reinforce education at each meeting, such as having brief PowerPoint presentations, Green suggests.
The presentation will discuss what the criteria mean and how to review a study based on the criteria. Structuring an IRB meeting around the criteria for review can save time, Green adds.