IRB expert strategies for improving PIIRB relations
Best Practices Spotlight
Empathic responses build trust
IRBs should ask themselves: Are we gatekeepers? Or are we collaborators, navigators, and concierges?
Their answer partly depends on how investigators and research staff view the IRB’s role and actions. And it depends on trust.
"Those of us with a lot of experience trying to run day-to-day operations for IRBs might think of our IRBs as a bureaucratic part of the university, and some IRB staff might think of themselves as gatekeepers," says Suzanne M. Rivera, PhD, MSW, assistant professor of bioethics and associate vice president for research at Case Western Reserve University in Cleveland.
However, it could be a mistake for an IRB to let investigators and others in the research community define the IRB in this way, she notes.
The status quo creates a revolving door relationship between the IRB and researchers, and it results in distrust, creating campus lore about how slowly the IRB handles protocols, Rivera explains.
"One bad experience with the IRB breeds a lifetime of distrust," she says.
"If we’re interested in improving the way IRBs and investigators work together then it’s important to think about how we all want the same thing — to promote high quality, professional research," Rivera says.
IRBs can do this by having empathy for the challenges researchers face. One strategy is to offer investigators alternative routes to achieving their goals when their initial proposals have problems, she adds.
"This creates a chain of events where investigators experience staff as navigators," Rivera says. "Investigators begin to see IRB staff as trained professionals with regulatory knowledge and helpful problem-solving skills, and so they trust IRB staff."
When IRB offices work collaboratively with researchers, the research community begins to see the IRB as adding value to its work and contributing in a way that makes projects more efficient and the process smoother, she adds.
Rivera, who has given many national talks on this subject, advises IRB staff to see themselves as assistants and not an obstacle to research. And she tells principal investigators about the pressures IRBs are under.
"I try to address both sides of the equation," Rivera says. "I want investigators to see IRB staff as professionals with a wealth of knowledge to offer, and I want the IRB staff to see that they can play a really important role in helping research get done."
The goal is to improve the often adversarial relationship between IRBs and investigators.
Here are some of Rivera’s tips on how IRBs can improve their image in the research community:
• Remind folks they are on the same team. This strategy will help in one’s workplace, as well as one’s personal life, Rivera notes.
"If we’re having an argument or disagreement, it’s helpful to remind each other that we’re all on the same team," she says. "Reframe it; it’s not me against you. We all want the same thing, so reminding everyone of that can be very helpful."
IRBs can promote a team atmosphere by inviting investigators to talk with them about what works and doesn’t work in the IRB office, Rivera suggests.
"Create a sounding board and invite investigators to speak with the committee," she says.
"When an investigator is taking a particularly adversarial stand to the IRB, I approach him and ask if he’d consider being a member," she says. "Some of his animosity is coming from a lack of knowing."
Having former opponents serve on the IRB can turn staunch critics into passionate advocates once they have an opportunity to serve and see how everyone can work together, Rivera notes.
Occasionally a conflict between IRB staff and an investigator can escalate, and this is when research program leadership or an IRB chair might step in to bring about a resolution.
"By meeting with the investigator, listening actively and with an open mind, I’ve been able to offer a third-path solution that meets the investigator’s needs and doesn’t cause IRB staff to break rules or compromise a principle," Rivera says. "IRB staff is overworked and under-resourced, and sometimes there isn’t time to take a moment to think creatively about an alternative solution because people are trying to keep their heads above water."
• Don’t take it personally. "Don’t take it personally because if we take it personally whenever someone is getting difficult with us, it’s easy to get burned out on this job," Rivera says. "It could be you’re the fifth person they’ve called, so remind yourself that everything is not about you; the person could be having a bad day for a hundred different reasons."
Occasionally, someone will criticize, complain, or even yell at an IRB staff professional. It happens, and IRB staff should learn how to handle these conflicts without taking them personally.
"What is essential is to be professional; professionalism is mandatory at all times," Rivera says. "Use professional, accurate and timely goals for providing service."
If an IRB client is abusive, the office leadership should put an end to it.
"It’s not appropriate to be abused, so if anyone is screaming at the staff, using foul language, or threatening to have them fired, then it’s not okay," Rivera says.
The key is to prevent unnecessary conflict by being respectful and making sure that whatever the IRB is requiring is logical and makes sense, she notes.
An IRB that reviews its website and looks for ways to make its requirements clear and easy to navigate can help reduce unnecessary acrimony and frustration among researchers and other clients, she adds.
"You should have a very clear and easy-to-navigate website that includes all of the steps for an IRB application," Rivera says. "And hold office hours once a week where principal investigators can bring in draft protocols and get assistance with them before entering them in the online review system."
• Choose your words carefully. IRB staff need to maintain a calm, dispassionate demeanor when explaining an IRB’s actions, Rivera says.
"Avoid a power struggle and don’t be hostile," she says. "Don’t let your own emotions escalate."
Also, IRB professionals delivering bad news should reframe the news in terms of what is possible, she suggests.
Instead of sending out a quick email saying the request is denied, IRBs should speak with investigators face-to-face and offer suggestions for what might work, Rivera says.
"Be constructive and helpful rather than [just] sending an email," she says.
This approach especially applies to emails and any communication that is not face-to-face, she adds. (See tips on writing professional emails, page 115.)
"A lot of IRBs do their work by email, and it’s a tricky medium," Rivera says. "People use it more informally than a business letter."
Rivera suggests IRB staff treat an email as they would a typewritten letter by always using a salutation, making sure it’s accurate, and by avoiding sarcasm or humor, which can be misunderstood too easily.
• Be clear about expectations. IRBs can facilitate positive behavior by setting clear, logical rules prospectively, Rivera says.
"How can people know your expectations unless you’ve laid them out?" she says. "So avoid taking capricious actions or using what seems like a good idea at the time approach."
Investigators need to have a confident sense of who the IRB is and how it would respond to a particular modification or request, she notes.
So IRBs should avoid inconsistency, which results in investigators thinking that one time they brought the IRB a modification that was approved, and then the next time a similar situation was denied.
"Maybe there’s a good reason for the different answers, but the way to head off these concerns is to set clear, logical rules up front and be transparent about them by having them on the website," Rivera says.
"Anticipate and minimize obstacles to compliance," she suggests.
For example, if an IRB knows its clients work between 9 a.m. and 5 p.m., then it would be helpful to make the IRB deadline between 5:30 p.m. and 6 p.m., giving them a little time to make it to the IRB office to drop off anything, she says.
"Or in case they are kicked off the online review system, have a drop box available," Rivera adds. "Maybe you could send a courier over to the satellite office so they don’t have to come to the main campus to drop off materials."
The key is to anticipate obstacles and minimize them.
"This reduces criticism that you are throwing up obstacles, and you are showing that you are making it easy as possible to color within the lines," Rivera explains. "Researchers will feel invested in the process, and it will make more sense to them."
Emails are OK, except when written casually
Take a professional approach
IRB staff should learn how to write professional emails, which mirror hard copy letters of previous generations, an expert advises.
"I've actually put together a cheat sheet for my staff about email principles," says Suzanne M. Rivera, PhD, MSW, assistant professor of bioethics and associate vice president for research at Case Western Reserve University in Cleveland.
Rivera counsels her IRB staff to use emails sparingly when communicating with researchers. For instance, if a face-to-face meeting or phone call would be a better way to resolve a problem, then take the time for these.
"Emails can be a good thing, but if it takes three or four times back and forth to be understood then you really should get out of the chair and go see the person," she says.
Here are Rivera's email tips:
- Never send an email when you are angry. Save as a draft and look again in a few hours (or the next day).
- Treat your emails like a postcard — assume anyone might read them.
- Avoid sarcasm and humor when conveying important information. Email is not a good medium for joking.
- Put yourself in the other person's shoes.
- When in doubt, remember the "Golden Rule."
- Also, here is a list of email errors to avoid:
- lack of a proper salutation;
- lack of a "kiss" [keep it simple stupid] introduction sentence;
- imprecise use of language/confusing prose;
- incorrect grammar, punctuation;
- overly familiar tone;
- "yelling" your message (ALL CAPS);
- sloppy forwards;
- disrespectful use of quotation marks;
- lack of a "kiss" concluding sentence;
- spelling errors;
- sloppy copies;
- unhelpful subject lines;
- using email when face-to-face or phone contact would be better.
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