After 32 years as an IRB member and 20 years as chair, one IRB expert says the key to IRB meeting success could be boiled down to one word: Respect.
“Be respectful,” says Peter Iafrate, PharmD, chair of the University of Florida IRB in Gainesville. Iafrate spoke about IRB chair meeting management at PRIM&R’s 2016 Advancing Ethical Research Conference, held Nov. 13-16, 2016, in Anaheim, CA.
“It works both ways,” he says. “We expect investigators to respect the process of human subjects review, and board members need to respect that these people are trying to do good research.”
Iafrate should know. He estimates he has chaired around 750 board meetings. Also, for the first 2.5 decades that he was on an IRB, he also was the institutional director of pharmacy. In more recent years, he has been an IRB chair as a full-time job.
“I do more than run the board meetings,” Iafrate says. “I help oversee the office.”
Iafrate has the following best practice suggestions for running a better IRB meeting:
• Know thyself. “If you are going to run an IRB, then you have to know first who is your IRB, what is the membership?” Iafrate says. “Ideally, you have both new members and veteran members because it’s important to get different perspectives.”
The board also needs regulatory and institutional knowledge.
“For example, our board of 22 members has only four people who have been on the board for more than 15 years,” Iafrate says. “About 60% of the members have been on the board for less than two years.”
But having even a handful of experienced members is important. It’s also important to have professional diversity. The University of Florida IRB has members from the colleges of medicine, dentistry, pharmacy, nursing, allied health, and other areas, he says.
“Make sure your members represent the types of protocols you typically see,” Iafrate says.
• Share the workload. “Most IRBs have a designated reviewer system,” he says. “We have a designated reviewer system with a lead reviewer and two secondary reviewers.”
All board members receive information electronically, and the designated reviewers also bring up particular issues.
• Give advance warning. IRB members shouldn’t go to a board meeting without knowing in advance which issues might be controversial, Iafrate says.
The chair can look through the agenda for something that might require longer discussion. Then the chair could give board members a heads-up on the item.
For example, Iafrate might tell the board that a particular study plans to enroll wards of the state, which is a major issue related to enrolling a vulnerable population.
“The other thing I would do is if I have a controversial issue that might require some kind of outside help, like legal services or a privacy office, I’ll make sure someone from that office is there for that discussion,” he says.
• Provide comfortable space. When IRBs meet for hours at a time, it’s important to have a comfortable meeting space. There might be a kitchen area near the conference room. Chairs should be comfortable. Perhaps there are microphones at each seat. If the meeting is early morning, then breakfast could be provided. Likewise, if the meeting stretches past noon, there could be lunch.
“Members should feel free to move around, to step out of the room,” Iafrate notes.
• Open meetings. While some institutions do not permit researchers and research staff to attend the IRB meetings, they are welcome to the University of Florida IRB’s meetings, Iafrate says.
For one thing, the IRB has no choice since it’s located in a state with a sunshine law that requires any state meeting to be open to the public. This rule applies to university meetings as they are public institutions, he explains.
But the IRB also encourages researcher attendance because it can help streamline the review process. “If the principal investigator is there to answer questions, the likelihood of the study getting tabled goes down significantly,” Iafrate says. “So for us, it’s helpful.”
This doesn’t mean the IRB allows the investigator to dominate the meeting, however.
“As chair, you have to run the meeting,” Iafrate says.
• Control air traffic. “One thing you have to do as a board chair is a little bit like air traffic control,” Iafrate says. “There are a lot of things going on that you have to pay attention to: your time, who is in the room, whether you can sense someone getting agitated.”
Chairs must pay close attention to the room’s atmosphere, review the long list of items on the agenda, and always think about what’s coming up next, he suggests.
When a board member is filibustering, talking for well past their allotted time, it’s a good idea to keep the discussion going with a well-timed interjection. “I think the best way to do it is to inject some humor into it,” Iafrate says.
“So if I have a member going on and on about a particular protocol, I could say something like, ‘Chuck, you know they served lunch a half hour ago, and I think everyone is getting hungry,’” he says.
The other strategy is to appeal to the length of the meeting: “Look at the clock and say, ‘We’ve got 30 more things. Is there any way you could summarize where you’re at with this?’” Iafrate says.
• Give occasional overviews. After several people have spoken on a topic, it’s a good idea to provide the board with an overview of the discussion.
“I’ll be busy jotting down notes, and then sometimes I’ll cut off the discussion by saying, ‘Okay, what we have so far is this, this, this, and this. Is there anything new that anybody has?’” Iafrate says. “Or I can say, ‘It seems like we’re circling the airport at this point. Does anybody have anything additional they want to say?’”
It’s a fine line between allowing people to talk freely and cutting them off prematurely, he says.
• Work with PIs. Investigators attending the meeting might receive a handout that explains what is happening. Guests, including principal investigators, sit in chairs off to the side of the U-shaped board table. The board discusses the study first and, when it’s appropriate, Iafrate will call on the study’s representative.
“Sometimes they want to jump into the conversation right away, and I’ll say nicely, ‘I’ll tell you what, let the members get all of the issues out, and then I’ll let you talk,’” Iafrate says.
It’s the chair’s role to manage those kinds of details, such as when the study representatives speak, how the board is perceived by guests, and how the interaction goes.
“We’re all in it for the same purpose, but sometimes the board can sound a little harsh and I have to pay attention to that and try to soften the discussion without softening the issue,” he explains.
“When the discussion is over, I’ll ask the study staff to leave the room and I’ll say something like, ‘If we could get you to step out for a few minutes, we’ll come out and let you know the board’s decision,’” Iafrate says. “Then I’ll thank the visitor for helping us inform the board’s discussions.”
• Tone down attitude. Occasionally, there is a board member whose tone sounds harsh and overly critical. The IRB might receive complaints from meeting visitors. When that happens, Iafrate might have a meeting with the board member to discuss how she or he is coming across.
“I want to make sure they are aware they’re coming off a little too aggressive or harsh,” he says. “But at some point that might just be who they are, and if they don’t want to change, I’ll dismiss them from the board.”
• Deliver gentle reproach. IRBs often receive submissions that are poorly prepared or are lacking in necessary information. When this happens, the board will need to let a researcher know that the submission needs work, but this can be done diplomatically.
Iafrate offers the following examples of the wrong way and the right way to deliver criticism:
- Wrong way: “You obviously did not think through this protocol before you submitted it.”
- Right way: “There are a lot of issues you didn’t address. Would you like someone to contact you about helping with this submission?”
• Predict pet peeves. With experience, IRB chairs can predict each board member’s pet peeve. “It might be someone who is always looking at the benefit section of a consent form to make sure it’s fairly described,” Iafrate says.
• Make voting confidential. “One thing that has changed for our board is we used to vote by raising your hand, and now we have a simple system that uses an electronic vote,” Iafrate says. “There’s a dynamic to voting by hand: Everyone knows how you voted.”
This can lead to people voting with the majority out of peer pressure, not because they truly feel that way about the study.
The new electronic system has a keypad for each board member. They can type in the number one for “yes,” the number two for “no,” and the number three for “abstain.”
When the chair calls for a vote, the projection screen shows the tally, and when it’s done confidentially through the electronic system, the vote almost never is unanimous. People feel more at liberty to vote as they like, rather than voting one way out of peer pressure.
• Provide follow-up. Once the meeting is over, the chair’s job is not done. Now the chair has to make sure that the board’s decisions are communicated to all stakeholders, Iafrate says.
“I know that at the end of the meeting I’m going to hear from certain investigators, and I’ll prepare for that,” he says.
“Also, I make notes during the meeting about the issues we’ll need to follow up on,” Iafrate says. “It might be to tweak this rule or get this issue out to the research community because a lot of people are doing this wrong.”
After 32 years as an IRB member and 20 years as chair, one IRB expert says the key to IRB meeting success could be boiled down to one word: Respect.
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