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By Melinda Young
The most important way to improve IRB meetings is through preparation. “It’s a moving target,” says Francis J. DiMario, Jr., MD, MA, CIP, professor of pediatrics and neurology at the University of Connecticut, and associate chair of academic affairs, department of pediatrics, and medical director, human research protection program, at Connecticut Children’s Medical Center. DiMario also is IRB chair at Connecticut Children’s Medical Center.
“The IRB chair has to have a sense of what’s coming up on the agenda, and anticipate an important discussion point,” DiMario says. “You don’t always have control over how the conversation evolves, so just have people put their thoughts on the table.”
DiMario makes these suggestions for improving IRB meetings:
• Reduce redundant debate. IRB chairs can guide people to state their positions succinctly, and without restating someone else’s opinion.
“I don’t want to cut off people too much, but it’s important to limit them in making their point,” he says. “If more people chime in with the same point of view, but say it in a slightly different way, then the chair can say, ‘Yes, we’ve heard this already,’ and move the conversation forward.”
When a discussion or point is not clear, DiMario asks people to reframe it: “I say, ‘Please help me understand what you’re saying.’”
If someone has taken five minutes to state their point, it usually could be reframed within seconds, he adds. “Rephrase it in a succinct statement, and they all agree that they understand what was just said,” DiMario says.
• Let people disagree. “People don’t have to always agree. You don’t need consensus on every point,” DiMario says. “It’s nice to get complete consensus, but we should move toward a consensus.”
Most of the time, IRB members will agree on a study approval, but sometimes a member will have a different point of view, he adds.
“They might want to stand by that point, and that’s OK,” he says. “It’s important that if they disagree with the general group decision that everyone understands why that is. It’s not appropriate for people to take a vote and not hear why.”
Any IRB members who disagree with the general group decision, particularly if they feel strongly, should explain their thoughts, he adds.
Chairs also should keep in mind that there could be multiple solutions to any minor problems with a study. “Trivial problems do not need optimal solutions,” DiMario says. “It doesn’t have to be perfect. The discussion should center around how the study meets or does not meet the criteria. Even if it’s not optimal, it’s still acceptable.”
Similarly, if board members argue over a point, the chair can insert a phrase to get them on the same plane.
“Say, a procedure is being done, and some people are uncomfortable with it, while others argue that it’s not the procedure, but the duration that it takes,” DiMario says. “The chair can ask, ‘What does or does not meet approval criteria?’”
If the disagreeing parties agree the study meets approval criteria, then that settles the dispute.
• Encourage board members to talk. “The folks we work with are pretty trusting of each other,” DiMario says. “I make a point to always ask their opinion on everything, even if they’re quiet.”
It is important to gain each board member’s insights. The more the IRB chair works to include everyone, the more often people will speak up, he says.
“If you don’t listen to them, they won’t say anything, but if you engage them, they’re more likely to speak up,” DiMario adds. “As chair, I try to speak last, letting everyone else have their input, and I don’t want to be the primary decision point.”
One way to engage members is to ask them direct, simple questions, such as:
- Do you agree with this?
- Does this make sense to you?
- Does this sound understandable to someone reading these descriptions?
- Do you do this in your job?
IRB chairs can quickly learn what to expect from board members. To keep people focused on the IRB’s review goals, the chair can remind people that their questions should address the approval criteria — not tangential issues.
“Is it a good-enough project, and is it meeting our approval criteria?” DiMario says. “Scientist board members get excited about making a better project, but that’s not what you have to determine; you have to make sure it’s safe and reasonable.”
The IRB can overlook the improvement part, unless it is an absolute necessity, DiMario says.
• Encourage diligence. Occasionally, IRB chairs deal with members who slack off a little in their summaries or reviews of submissions. One way the chair can encourage greater diligence and less slacking is through feedback during meetings. The chair can say, “Yes, that’s a good summary,” or “That was well put together,” when the reviewer does a good job, DiMario says.
When the summary is lacking, the chair could amplify what was not put together well. DiMario might comment that he was not clear about what the reviewer said, and ask the person to restate it.
“I would point out something that was not put together clearly, saying, ‘As I read through this, these are some points I thought were important to consider,’” he says.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.