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Learn how IRB works and what board members want
Walk in each other's shoes
Clinical research investigators and coordinators could save time and aggravation during the IRB review process if they spent some time learning how their particular IRB works and what it wants.
"I work with several IRBs, and at any given time I have 200 applications out there that I'm watching from approval to amendments and renewals," says Tonya Edvalson, BS, CIP, research compliance manager at the University of Utah in the department of obstetrics and gynecology in Salt Lake City, UT. Edvalson spoke about anger management at the PRIM&R 2008 Advancing Ethical Research Conference, held Nov. 17-29, 2008, in Orlando, FL.
"So I have to know everybody's culture and what this board likes and what that board likes," Edvalson says. "Understanding what the IRB's role is makes this job easier for me, so I can figure out a way to make them happy."
Edvalson worked for an IRB for seven years, and her experience left her with valuable insight into the IRB's world.
For instance, it's a good idea to observe an IRB meeting, if the IRB is open to this, Edvalson suggests.
"This way they can see their peers, see the interaction between IRB members and the thought process that goes into a protocol review," she adds.
Sometimes an IRB's requests for additional information can be confusing or misinterpreted. This might lead to a protocol approval being postponed through two or more IRB meetings. When this happens, it might be essential for a PI to meet with the board to ask them about the issues holding up the protocol, Edvalson says.
"Sometimes it's the board preference and not a board requirement that you do something differently, and you need to find out why the IRB is asking you for this," Edvalson says.
In this case, there might be a way to resolve the issue without redesigning the protocol or making time-consuming changes, she adds.
When Edvalson discussed the CR site-IRB relationship at the PRIM&R conference, she asked investigators to tell what their work pressures were. And she asked IRB members to talk about their pressures on a day-to-day basis.
"The lists were very, very similar," Edvalson says. "We have the same pressures and expectations, and seeing how similar they are was very fun."
Both PIs and IRBs have research participants' best interests at heart, but they're just looking at it from different angles, says Ann Johnson, MPH, IRB administrator at the University of Utah in Salt Lake City, UT.
"PIs need to know that IRBs are doing what they can to not burden them, but they want to keep participants safe and well-informed," Johnson says. "And if IRBs are willing to talk things out before a conflict escalates and plan together with CR sites, then they'll build a positive relationship and everything will run smoothly."
CR coordinators or PIs also might take time to find out what an IRB's policies and procedures are, Edvalson suggests.
When Edvalson worked in an IRB office, new investigators would sometimes ask to sit in the office for a day to see how things worked.
"They had a putting-yourself-in-our-shoes kind of perspective," Edvalson says.
This approach takes time upfront, but it can work, especially if an investigator begins to think about human subjects protection in the same way as IRB members.
Clinical research professionals need to retrain themselves to think of IRB members as being smart people who are reviewing the study to improve its protection of subjects, Edvalson says.
If the IRB sends a protocol back with requests for changes that seem unreasonable, then the principal investigator should call the IRB chair or reviewer and ask why the changes were requested and whether there was some part of the protocol that upset the board, she suggests.
"Take the time to gather information," Edvalson says.
In some cases the IRB's questions might be too vague, and it would be useful to ask for a clarification before attempting to answer them, she adds.
"If you haphazardly answer it or answer curtly and don't address the question, it will come back to you," Edvalson explains. "Maybe the IRB reviewer has had a hard day and doesn't appreciate that you said, 'If you had just read page 3…'"
Or maybe the question isn't exactly as big an issue as the PI thinks it is.
"So really sit back and think about what they're asking," Edvalson suggests. "If this is a recurring problem or something that really is a thorn in your side, then address it with them."
Occasionally, there will be a personality conflict with a particular IRB reviewer, and maybe the only way to handle it is to try to make the nitpicking changes the reviewer has requested, or to ask the IRB chair to address this problem internally.
"You have to understand that some of the things the board asks you to do is because these are regulations and there's nothing anybody can do about it," Edvalson notes. "If it's a regulatory issue, then you have to figure out how to make it work; if there's a possible compromise, then work with them, talk with them, and try to learn something from it."
Also, it's important to show the IRB your appreciation for their work on your behalf, Edvalson advises.
"Be there with the IRB and show your face, calling and saying, 'Thank-you,'" Edvalson says.
"That goes a long way to facilitate relationships," she adds. "At the end of the day, everyone wants to put together a good protocol and do good research ethically and responsibly."