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Conflict resolution tips for CT staff and IRBs
Anticipate questions before they're asked
Conflicts and problems will always arise when clinical trial investigators and coordinators interact with IRB staff and members. But these can be more easily and happily resolved if CT professionals learn how to meet their own goals without creating ill will in their communication with the IRB.
So several experts on research and IRB conflict resolution and anger management offer these suggestions:
1. Understand how the IRB has multiple responsibilities.
"Researchers need to understand that the IRB has three masters," says Hannah R. Rothstein, PhD, professor of management and IRB chair at Baruch College, Zicklin School of Business in New York, NY.
"First, they're responsible for protecting human subjects, and that's why they were created," Rothstein says. "They need to take the role of subjects who can't be there."
Secondly, they are protecting researchers, whose research would suffer if they make a human subjects protection mistake, she adds.
"Researchers could lose their ability to get future grants; their research would suffer, and studies would be closed down," Rothstein explains. "So even though it looks like the IRB is slowing them down, it is looking after them, as well."
And, third, the IRB is tasked with protecting the institution, Rothstein says.
"Nobody wants to be on the wrong side of the Department of Health and Human Services or the National Institutes of Health (NIH) or be the person who got research shut down for the whole university," she says.
For example, at Baruch College, which has more than two dozen campuses, one rogue investigator's mistake could impact 27 different campuses, Rothstein notes.
When there's a dispute between a PI and IRB, Rothstein will mediate and try to get both sides to listen to the other, putting themselves in the person's shoes, she says.
"This goes a long way to resolving a particular conflict," Rothstein says.
2. Anticipate the IRB's questions and address them early.
"If you know you work in a particularly complicated field, or if you have a study coming up and think the IRB may have some problems with it, then set up time with the IRB director or someone in the office and say, 'This is my study, please just send me in the right direction one some of these issues because I think the board might have concerns with it,'" Edvalson suggests. "You can say, 'I just want your advice on the best way to address these issues.'"
Anything a PI can do to anticipate the IRB's questions helps to expedite the process.
For example, Edvalson works with protocols involving pregnant women and children. So when she submits an application to the IRB, she states how the CT site will address regulations particular to this population.
"The regulations say that a pregnant woman may be involved in research if all conditions above are met, so I address the list of regulations and might explain that there is no risk to the fetus, and risk to the woman is minimal," Edvalson explains.
Likewise, if the study involves an investigational drug, Edvalson will reference literature on that drug, showing the IRB that the PI and CR staff have given this some thought.
"It's right there, spelled out for them so they don't have to look to see if we've addressed it," she explains. "I think that builds trust between our sites and the multiple IRBs."
The key is to address all potential regulatory questions to reduce the amount of time spent going back and forth with the IRB, Edvalson adds.
Often PIs will wait like college students cramming for a test to complete the IRB application the night before it's due, she notes.
"Their application will seem like an afterthought, and from the board's perspective, there should be a lot of thought that goes into it," Edvalson says.
While it's difficult to anticipate all of an IRB's questions, PIs and CT coordinators can do much better at this if they put more time into the application process.
"Surround yourself with people who do know the regulations, so you'll understand what it is the PI needs to address," Edvalson suggests.
3. If the IRB reaches out, then take the offered hand.
Many IRBs embrace the role of helping PIs and CT staff with preparing protocols according to the IRB's requirements.
"We tell the PI that we're here to help," Johnson says. "And if there's a redundant requirement that the PI doesn't think is necessary, then we're here to tell them why it's necessary and what their options are in fulfilling that requirement."
The University of Utah IRB also will help CR staff plan their research protocol before it's sent to the IRB, so they'll be well aware of what the IRB will require, Johnson says.
"That way when the protocol is sent here it doesn't get stuck here," she adds.
"We have an open door policy for PIs before they submit research to the IRB," Johnson says.
Both board members and IRB staff are open to talking with PIs before the review, as well, she notes.
"We encourage reviewers to give PIs a call to try to get as many issues as possible taken care of before they have the board meeting," Johnson says.
The IRB staff might ask CR staff what the particular research project will entail, and staff members will offer suggestions for meeting requirements related to that project, she adds.
"We might say, 'Here's what we think would work best for recruitment,' and the PI could say, 'This may not be the best thing, what about this?'" Johnson explains.
"We can help them clarify issues in their application or protocol so others who read their studies down the line don't have the same confusion," she adds.