Expectations and communication issues are the two biggest challenges between principal investigators and the IRB community.
“There’s often not a recognition that expectations and communication define the nature of their relationship,” says Julie Slayton, JD, PhD, director of the office for the protection of research subjects and professor of clinical education at the Rossier School of Education at the University of Southern California.
IRBs set expectations through their websites and response letters, but they might not have articulated those expectations to themselves and investigators. “No one says, ‘What are our clear expectations? What do we expect them to do?’” Slayton explains. “If you haven’t articulated clear expectations, then it’s difficult to impart it in a clear way to the research community.”
From the principal investigator (PI) perspective, researchers might not fully appreciate that IRBs can be advocates and not merely a clearing house or impediment to putting research in the field, she adds.
“When I did my PhD, I wasn’t clear about what IRBs did until I worked for the IRB,” Slayton explains. “Having those two hats on at the same time gave me a clear perspective of what each part of the conversation sounded like and what each member is asking for.”
Without clear and understandable expectations, communication problems and distrust can grow. To prevent these issues, IRBs should name their expectations, first internally, and then through intentional messaging. “Find ways to communicate your expectations in clear ways,” she explains. “Both sides have pressure, so having empathy for both sides makes it easier.”
IRBs also can improve communication with PIs by giving them context and helping them understand IRB requests and decisions. “Think about the context of conversation, what needs to be said, and why it needs to be said,” Slayton says. “Those things are important — inside the IRB as well.”
IRB staff and members should work toward building more productive, transparent relationships with the research community. The IRB’s goal should be to advocate for researchers, and the research community to advocate for the IRB, she says.
“When we have things like COVID-19 and a shutdown, and it goes from five weeks to 11 weeks for an application to be approved, we want people to say, ‘I have an understanding and appreciation for the work asked of IRBs,’” Slayton says. “When there is better clarity of expectations, it’s more likely members of the research community will help us get the work done.”
As the pandemic continues, IRBs have an opportunity to set new expectations about how disruptions and changes will be handled. “One thing we did was construct a FAQ response to the COVID ramp-down and ramp-up,” Slayton says. “We set up a web page to be responsive to ramping up studies, telling investigators exactly what to expect and where to get resources to complete the actions they needed, including giving them better information and transparency.”
IRBs should direct researchers to their websites, encouraging them to see the website as a resource. “When you look at our website, there is COVID-19 information,” Slayton says. “The website explains what we want to focus on and who does what.”
The website also tells researchers what they need to do before submitting to the IRB. “All those things are explicit on the page,” she adds. “Here’s what we need for you to be successful in our partnership.”
Focus on Intentional Messaging
Another important step is intentional messaging. IRBs can improve their intentional messaging by following these examples:
• Read from the PI’s perspective. “Go back to your website and ask yourself, ‘If I am a researcher and read this, what is it I understand?’” Slayton says. “Who are we messaging? What is the content to it?”
Many websites are difficult to navigate and find the necessary links and information. IRBs should revisit these and make improvements, she adds.
• Prepare for discussions. “Today, we have two discussion with different faculty members, and we have a pre-meeting where the team and I will discuss what we want to communicate at those meetings,” Slayton says. “We talk about what’s extraneous, what will interfere, and who will lead. We talk through all of those things so we’re not just getting into a room and starting a conversation [cold].”
If a difficult meeting is not going well and emotions are frayed, Slayton will handle it discreetly. “Last week, as I listened to someone in a meeting, the person’s emotion was getting the best of him. I sent him a private text, saying, ‘Take a deep breath,’ and that worked,” she explains.
• Let it go and adapt. “Be willing to let go of things,” Slayton says. “We’ve done newsletters that are terrible, just flooding people’s inboxes and not doing anything [useful].”
It is better to stop sending weekly or monthly newsletters and instead send researchers bulletins when there is something new and important to communicate.
When something affects the study submission workflow, the IRB can send an email bulletin. “We reserve that for an email that someone will recognize as very important,” Slayton says.
When there is something important to tell an investigator, the IRB can hold a video or teleconference.
“I have two meetings with different investigators today to talk about challenges with their applications. We do that over Zoom, face to face,” Slayton says. “The phone is OK, but it doesn’t allow for visual cues.”
• Use social media. “We have a Twitter account that went from no users to 100 users to people retweeting to their universe,” Slayton says. “When something goes live on our website or in a bulletin, it gets retweeted.”
• Respond comprehensively. It is important that an IRB’s communication with investigators is consistent and comprehensive. “The way analysts write to researchers should have a tone that is thoughtful, rather than just, ‘We need to tell you something,’” Slayton explains. “It’s a combination of finding ways to communicate that are meeting our stakeholders where our stakeholders are. We’re reassessing the quality and type of communication.”
For example, an IRB analyst could write, “Your application is being returned because you didn’t do A, B, C,” she says. “This is stark and in your face, and might come across as confrontational.”
Instead, the analyst could write, “We appreciation your application, and we would like to give you the context for why we’re returning this to you,” she adds. This reframes the rejection, using language that is less likely to trigger a negative emotional response.
Another way to reframe this kind of response is to recognize trigger words like “but”: “Your application was good at B and C, but did not do F and G,” can be improved this way: “Here are the things we need you to do to complete the review of your application, for example,” Slayton says. “I’m a professor and think a lot about the writing. Things are usually vetted with me.”
Slayton has worked with IRB staff to improve their empathic writing skills. “We developed a number of templates, usually particular to a specific challenge or situation,” she says. “If we have something we’ll be writing about a lot, then we’ll correct it, and I will be one of the people who reads it.”
If there is an especially contentious letter that the IRB needs to send an investigator, Slayton and the associate director will review it for tone and grammar, she adds.