By Melinda Young
There are natural conflicts between IRBs and principal investigators, but IRBs can take several steps to improve this crucial relationship.
For instance, IRBs should treat everything on a case-by-case basis, depending on the situation, the principal investigator (PI), and the IRB’s policies, says RoseAnn Fleming, CIP, interim director of the University of Southern California IRB.
If there is a policy disagreement or issue with an investigator, then the IRB director can quote the policy. IRBs that use internal standard operating procedures (SOPs) also can cite those in explaining decisions to PIs.
“Is the PI’s expectation reasonable? If not, then why?” Fleming says. “If it is reasonable, why hasn’t it been met?”
Fleming suggests IRBs use these methods to improve the IRB’s relationship with PIs:
• Keep communication door open. “Talk to staff and find out what their everyday work is like and what are the most common reasons for sending PIs back-up questions,” Fleming suggests.
When PIs contact Fleming, it usually is a sign that they are frustrated, upset, and did not get what they wanted, she says. “My goal is to see what’s reasonable. I try to accommodate them, but I also put the responsibility back on them.”
When a study goes through the IRB process several times, it is likely because there is miscommunication somewhere, Fleming says. “It’s my goal to find out where that miscommunication is,” she explains. “Oftentimes, it’s because PIs are told to do something they don’t want to do, and I have to tell them why they need to do it.”
The problem often can be resolved when IRB staff tell PIs why they made that decision. They can connect it to policies and regulations and explain how their job is to help facilitate the research process while protecting human subjects, Fleming says.
“When they understand why you’re doing it, they are more reasonable,” she adds.
• Use humor to break the ice. “Each analyst has their own way of dealing with different investigators, and I personally use humor because that breaks down the angry PI,” Fleming says.
Humor puts people at ease. “I usually tell an investigator that I’m not a scientist and I don’t play one on TV,” she says. “My other line I use is: ‘The answers I have to your questions are like adult diapers, everything depends on something else.’”
After that icebreaker, Fleming will launch into how a study can go from exemption to full board, based on details about drug use and whether identifiers are used. “The type of review you’re doing depends on what you’re doing in the study,” she adds.
• Invite PIs to be part of the process. Sometimes, Fleming invites investigators to become IRB members. Her theory is that if a principal investigator is concerned about how the IRB works, then the PI could join the board and help change procedures, she says.
“Most say, ‘No, thank you,’ but once in a while they’ll say, ‘Yes,’” Fleming says.
Once PIs begin to understand how the IRB office and process works, they can become advocates for this check and balance in human subjects research. “They might go out and tell their peers, ‘I hated the IRB at one point, but I understand them now,’” she says.
The investigators who accepted Fleming’s offer have become the best advocates for the IRB, she notes. “Their expectations for other researchers were higher than their expectations of themselves, at the beginning,” she adds.
Fleming’s approach is based partly on her experience of working in clinical trials. “I know what their frustrations are,” she says. “I once hated the IRB, too, but I know there are legitimate reasons why they’re asking these questions.”
• Instill policy of zero tolerance for bullying. “I will not tolerate abusive PIs to staff,” Fleming says. “Our institution has a policy, and I refer them to that policy.”
Fleming has met with PIs to let them know their behavior was unacceptable. Her conversation with them is along the lines of “We are all here to do our best and accommodate you, but you have to understand you can’t go around screaming at people,” she says.
If it were necessary, she would escalate the issue to human relations, but that rarely is the case, she adds.
• Create policies to ensure a fair turnaround timeline. “We have a queue that new applications go into,” Fleming says. “They’re pulled out in the order they’re received.”
If the IRB asks nonscientific questions, then that review will return to the PI to resolve the issues. In a few cases, PIs prefer their protocols are first reviewed by a member of the board rather than IRB staff. Those studies are sent to the vice chair, Fleming notes. “If questions come from a peer, they’re more accepting of it,” she says. But those studies might take longer to review because they do not go through the usual process.
Developing ways to form an amicable working relationship with PIs is a good way to improve human research protection goals. For instance, IRB members and staff who PIs trust can be advisors. With their guidance, studies will go through the review process more efficiently and quickly.
There are good submissions and some bad submissions among the 2,000 new applications the IRB sees each year, Fleming notes. “Our volume increases every year,” she says. “Our goal is to help those who submit not-so-good submissions improve their applications.”