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'Shared frustration': Tensions arise in high stress world of clinical trials
Try honey vs. vinegar approach
Principal investigators (PIs) and clinical trial site staff increasingly work in a high stress environment with budget and deadline pressures that raise levels of stress and burnout.
Given these pressures, it's understandable that tempers sometimes flair and conflicts arise between CT professionals and the IRB.
"There's a general climate with the regulations that not only frustrates investigators, but also frustrates many human protection professionals across the nation," says Ann Johnson, MPH, IRB administrator at the University of Utah in Salt Lake City, UT.
"There's a shared frustration with IRBs and PIs when regulations are vague," she adds. "There's a lot of guidance that is lacking and needs to be built on."
Clinical trial investigators and coordinators sometimes make incorrect assumptions about the IRB's motivations, and this can lead to a flare-up when there's a mistake or crucial delay.
"If you're submitting something to the IRB, I think you should not automatically assume that this application is an exercise in bureaucracy," says Hannah R. Rothstein, PhD, professor of management and IRB chair at Baruch College, Zicklin School of Business in New York, NY.
"My main goal is to get everybody to reframe things," Rothstein says. "We need to make sure we're on the same side and find out what common interest is holding up the approval."
When investigators and trial coordinators fail to control their anger and frustration, the end result is negative, and the opportunity to improve the CT process is thwarted.
"If you make someone at the IRB mad and then they might put you at the bottom of the pile; the problem keeps reinventing itself," notes Tonya Edvalson, BS, CIP, research compliance manager at the University of Utah in the department of obstetrics and gynecology.
Consider the other person's view
Edvalson is in the unique position of having both worked for over a decade in clinical trial research and in having worked for seven years with an IRB. She's tried to smooth tempers on both sides and knows first-hand the pressures both CT sites and IRBs encounter.
The key is to try to look at the situation from the other person's perspective and to use language that doesn't assign blame, Edvalson suggests.
"You might ask, 'What is it we can do to make this work better for both of us because for me this is not working,'" she says.
Each IRB has its own stories about notorious investigators who yell at IRB staff and dislike the IRB, always seeing it as a negative interaction, Johnson notes.
Edvalson has experienced this from the IRB's perspective: "There was one instance when I was an IRB administrator supervising a lot of staff, and I could hear someone yelling at our receptionist, and I couldn't get off the phone call quick enough," she recalls.
"I walked outside and said, 'Hi, I'm Tonya. Do we have a problem and is there something I can help you with?'" Edvalson says. "And he pounded his fists on the table and said, 'This is a tragedy!'"
Edvalson invited the investigator back into her office and talked with him about the study. It turned out that the IRB office had lost something he'd submitted, so she helped him resolve the issue without further emotional outbursts.
"Everything was fine, and two days later he came back with candy bars and an apology," she says. "He said, 'I appreciate you guys for taking care of me.'"
The investigator was willing to come into the IRB office and speak with them and never had another problem again, she adds.
While candy gifts to IRB staff are a very rare occurrence, the outbursts are not.
"We have people who are just so rude to the IRB administrator," Edvalson says. "Fortunately, the IRB administrator is great and doesn't take them very seriously."
When Edvalson acted as a mediator between irate PIs and distressed IRB staff, she'd tell investigators that yelling and throwing things is unacceptable behavior and they should just sit down and take a deep breath.
Taking a positive approach
Principal investigators should try a positive approach first, Edvalson says.
"I say, 'Instead of yelling at her the next time, why don't you bring her a box of chocolates — you'll catch more flies with honey than with vinegar,'" she adds.
Also, while it's tempting for CR professionals to think the IRB is being unreasonable in extra requests regarding the informed consent process, it's likely that the IRB is looking at the situation from a perspective the investigator had not considered.
"I ask investigators to think about how they'd feel if it was their sister who was going to be a subject in a study," Edvalson says. "How would you want to have her treated and how would you like her to hear about the study?"
Each subject on each study should be treated with compassion, ethics, and understanding throughout a study, she adds.
Sometimes, even the most experienced and calm CR professional will encounter an IRB that seems difficult to work with.
"One time we had three board reviews, and it wasn't until that third board review that we were invited to come to the IRB meeting, and we finally understood what the IRB wanted," Edvalson recalls.
"The IRB would write what it wanted, but it wasn't connecting with us," she adds.
In these cases, open communication between the CR site and IRB would help.
Sometimes IRBs get caught up in mission creep, and board members need to hear the CR staff's perspective, Rothstein says.
"One way to handle this is for the PI and IRB to have a conversation," Rothstein says. "If the IRB invites the investigator in then they can explain why they handled it this way, and people can brainstorm for alternatives that meet both the IRB's concerns and the investigator's concerns."
Of course, to have a positive conversation between IRBs and PIs means that IRBs need to be open to hearing the other side too.
"I want IRBs to be better at asking why they're asking for a change and not just telling PIs that they want this particular sentence in the informed consent," Edvalson says.
"I had one instance where I was working with an IRB that was taking an unreasonable amount of time getting approval letters back, so I spent a lot of time tracking things," Edvalson recalls. "And even when I did everything in my power to get it in on time, they didn't review it."
Edvalson documented her actions, keeping a spreadsheet of submissions and tracking the time from study submission to approval.
"I could have called and said, 'How come you let my study expire in January? There was no reason in the world why it should have expired,'" Edvalson says. "The situation was very frustrating, but turning to a defensive mechanism would have reflected poorly on me, so I had to step back and not play that card."
Instead, she collected facts and showed them to the IRB staff.
"I said, 'This is what I see from this side, and I need you to help me understand,'" she says. "I told them: 'I have a job to do too, and when I'm meeting your deadlines and doing what you ask I have expectations that you'll do what you're supposed to do too. I hope your administration will recognize the work that you are doing and give you more resources."
The key is to respond in a way that puts the situation in a more positive direction for everyone involved, Edvalson says.