IRBs ease conflicts with investigators
Survey shows policies are only part of the equation
Most IRB directors or chairs can recount stories about their tensions with investigators. All boards must balance the institution's need to protect subjects with investigators' concerns about unduly hampering their research.
But not every IRB goes about that balancing act the same way. A recent qualitative survey of IRB chairs, directors and members showed a variety of approaches to dealing with conflicts with investigators.
Some of those approaches involved formal structures, such as open-door policies and invitations to investigators to attend IRB meetings. Others involved more of a matter of tone, says Robert Klitzman, MD, an associate professor of clinical psychiatry and director of the masters in bioethics program at Columbia University in New York City.
"Many of the IRB chairs and members said, 'We realize that researchers don't like us,' and a lot of them tried to respond to that," Klitzman says. "I was struck again and again by the number of IRB chairs who said, 'Therefore, I try to be charming, I try to engage them. It's not just what you say to researchers, but how you say it.'"
Klitzman says his survey originally set out to ask IRBs about issues of research integrity, but he quickly found that as chairs and directors talked about their roles, they continually brought up the problems involved in working with investigators.
Results from the survey of 46 IRB chairs, members and staff were published in a recent issue of the journal BioMed Central Research Notes.1 Klitzman says that while many surveys have looked at the complaints that investigators have about their interactions with IRBs, there's been little research into how IRBs manage these relationships.
He says the conflicts between IRBs and investigators are invariably about power.
"When I've interviewed researchers, they say IRBs have tremendous power," Klitzman says. "IRBs tend to say, 'No, we don't have power, we're just following the regulations,' but there's a perception that IRBs have power. And I think that's at the root of a lot of the tension."
Open doors and board rooms
He says many IRBs are actively fighting the perception that they are a "faceless bureaucracy," by taking steps toward transparency.
"The more there can be a sense of open doors and transparency and the notion that we're not the enemy and the notion to explain the reasons for what the IRB is doing, I think that can help both IRBs and researchers," he says. "It can help improve relationships and hopefully improve compliance and research integrity."
Some of those Klitzman surveyed were attempting to do this in both formal and informal ways. Formal structures such as having "open door" policies and inviting investigators to meetings were not universally employed, he says.
"I was surprised at the range," Klitzman says. "Some IRB chairs or administrators would say, 'I try to have an open door. I tell researchers whenever you want, just come by, email me, call me.'
"Others would say 'No, we don't allow researchers to contact individual IRB staff.' Investigators send emails to 'IRBinfo@(institution name). Generic. There's no name, there's no person; it's just a bureaucracy."
Similarly, some IRBs would invite investigators to meetings to hear the discussion about their protocols, while others didn't want them there. Some IRBs would allow the reviewing member to talk directly to the investigator, while others discouraged such interactions.
Klitzman noted that there are legitimate concerns about an investigator knowing who's reviewing his protocol.
"Should reviewers be anonymous? That's a worthwhile discussion," he says, noting one example where a reviewer was advised not to seek out the investigator to discuss problems with a protocol because the reviewer had a relatively low position in the investigator's department and could face difficulties because of it.
"There are issues that aren't easily corrected, but I think we need to realize that some flexibility is important."
Klitzman says he was surprised by the number of IRB chairs and directors who brought up the tone of their communications with investigators, rather than just the content of a yes-or-no decision about a protocol.
"They talked about charm and tone and style and saying no with a smile," he says. "They said, 'I have staff who are really good at this, and some staff who frankly aren't that good at it, at having the right charm and style.'"
Often, he says, the survey respondents who most often leaned in the direction of transparency and using a pleasant tone were women.
Klitzman acknowledges that some of the methods used by IRBs to promote a sense of openness can take their toll on staff. But he says they probably require fewer resources than a chair or IRB administrator might think.
"Having an open door, meaning people are welcome to come by — not that many people actually come by," he says. "A lot these are symbolic gestures. You don't want to be saying, 'Call me in the middle of the night at home.' But between 'faceless bureaucracy' and 'call me at home at night,' there's a wide spectrum of things you can do."
And he notes that many of these steps don't just improve the perception of the IRB; they also improve the quality of review. For example, when one IRB chair surveyed encountered a new research methodology, he invited the investigator to come explain it to the board. The IRB chair noted that this gesture helped from a public relations standpoint: "Investigators feel we're willing to be taught, and to reach out."
But in the process, the board also learns more about a new methodology.
"Some IRBs said we do a lot of PR work, and I think yes, that's PR work, but there's also substance there," Klitzman says.
Another important factor in gaining investigator buy-in is explaining the ethical reasoning behind the IRB's decisions, Klitzman says.
"It gets back to the issue of power," he says. "Studies of power show that people resent authority and power when they perceive that it's illegitimate. The more legitimate and transparent it is, if there's an explanation of the underlying reason for the power, people accept it, rather than thinking it's just being arbitrary or abusive."
Klitzman says he hopes that IRBs are willing to look at these ideas to help bridge the gaps that can occur with investigators.
"A lot of these things are easy to do," he says. "I would hope that this opens up a dialogue. I think people can at least think about these issues and see if there are things they can do to improve the tone and style of their interactions."
Reference
- Klitzman R. From Anonymity to Open Doors: IRB Responses to Tensions with Researchers. BMC Res Notes 2012 Jul 3;5(1):347.
Here's a sample Ochsner IRB meeting minute template It's used for new study reviews The Ochsner Institutional Review Board of Ochsner Health Systems in New Orleans has created templates for use in writing minutes at the IRB's meetings. These help the IRB keep documentation of meeting discussions consistent and accurate. Here are some of the items included in the IRB's new study meeting minutes template:
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Most IRB directors or chairs can recount stories about their tensions with investigators. All boards must balance the institution's need to protect subjects with investigators' concerns about unduly hampering their research.
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