Enabling IRB Compliance: Culture, Training, and Alignment

If you’ve ever felt like the Institutional Review Board (IRB) process is a maze of regulations, training modules, and endless questions and paperwork, you’re not alone. That’s why we recently hosted a webinar on navigating IRB compliance at higher education and healthcare institutions.  

To help us untangle IRB compliance requests, training, and alignment, we reached out to two incredible experts to participate in a panel discussion: Priya Desai, an IRB Analyst at Driscoll Children’s Hospital, and Maureen Wawsczyk, a Research Integrity and Compliance Officer at Ferris State University. 

Together, they shared their real-world strategies for turning compliance from an administrative hurdle into a truly collaborative partnership.

Let’s dive into their best tips for building a proactive, positive culture around IRB compliance, along with some of the most common challenges researchers face today.

Clearing up confusion: is it actually research?

One of the biggest hurdles compliance offices face is getting everyone on the same page about what requires a review. In many cases, a PI might consider an IRB review for their project because they don’t believe it applies.

Our experts noted that most researchers aren’t trying to break the rules; they just want to make sure they are doing the right thing. They raised several possible scenarios where this kind of confusion can arise:

“My project is exempt, so I don’t need to apply.” 

This is a myth. Even if a study involves minimal risk (like certain surveys or existing data analysis) and qualifies for federal exemption, investigators still must submit it to the IRB. The IRB, not the researcher, is responsible for officially determining that exempt status.

“It’s just quality improvement, not research.” 

Priya mentioned that investigators are often surprised to learn that a project they thought was merely quality improvement actually meets the threshold for IRB review.

“Expedited means a faster review.”

Another common point of confusion is the term “expedited.” Expedited refers to a specific category of research involving no more than minimal risk, not necessarily the speed at which the committee will review it.

Pro tip: Both Priya and Maureen highly recommend encouraging researchers to contact the IRB office early, before they even start the application. A quick conversation can prevent massive delays later on.

Making training stick

We all know that training is essential, but it can quickly become a pain point for both new and veteran staff. Keeping track of who needs what course, and when it expires, can be an administrative headache.

During their presentation, Priya and Maureen shared three key strategies for ensuring that faculty remain aware of, and engaged with, required training.

Make it part of onboarding

At Driscoll Children’s Hospital, CITI training is baked right into the onboarding process for new staff and residents. By providing clear instructions on what courses are needed and how to access them before the research even begins, expectations are set from day one.

Tailor the training 

Not everyone needs the same level of education. Researchers need training on how to design and conduct ethical research, while IRB committee members require much more intensive training to understand federal regulations, assess risks, and navigate the review system. Communication around training requirements should appropriately communicate these differences and ensure that staff understand what training is, and is not, required for their role.

Manage expiration dates

Expiration dates can vary by individual. For example, Maureen noted that at Ferris State, Conflict of Interest training expires every two years, Institutional Biosafety Committee (IBC) training expires every three years, and IRB projects have a five-year expiration. Transparent expiration date tracking and automated notification systems can help make sure everyone renews their training before it lapses.

Fostering a true culture of compliance

Building a culture where people want to comply takes time, transparency, and a lot of teamwork. It shouldn’t just be the IRB office sending out reminder emails; staff members should understand why training is necessary and feel empowered to proactively maintain their training certifications.

Our experts summarized three easy-to-implement practices for establishing and maintaining a culture of compliance at any organizaton.

Communicate that compliance is a shared responsibility

It takes leadership support, IRB guidance, and responsible investigators to make the system work. Keep leadership regularly informed about compliance trends and areas where researchers might be struggling so they can provide the right resources.

Use peer advocacy

Maureen found that having faculty members serve on the IRB committee was incredibly helpful. These faculty members acted as “boots on the ground,” helping to explain process changes to their peers in a more relatable way.

Celebrate the wins

When Ferris State rolled out new training requirements, Maureen wanted to ensure the transition felt positive and rewarding for everyone. She started sending out public emails to congratulate staff university-wide upon completing their CITI training. Earning that public recognition from their department heads and deans made the extra work feel valued.

Ready to Streamline Your IRB Process?

Building a strong culture of compliance doesn’t happen overnight. It takes ongoing education, transparent communication, and a true partnership between research teams and administration. Perhaps most importantly, better compliance requires the right systems in place to make doing the right thing as frictionless as possible. 

For more advice, check out our blog on 3 audit trail essentials to look out for to learn more about establishing audit-ready compliance practices at your institution.