By Melinda Young

As human research protection programs (HRPPs) and IRBs enter the next leg of the COVID-19 pandemic, they can draw on experience to find the best balance between safety and efficiency.

Each institution and IRB will face its own challenges — just as they did in March 2020, when most studies were paused because of the pandemic. But one of the more common challenges as the United States copes with more than eight months of the crisis is pandemic fatigue and burnout.

“We’ve seen a lot of burnout among healthcare workers,” said Allecia A. Harley, MPH, CRA, chief executive officer and chief strategy officer with Lake Shore Strategy in Chicago. Harley spoke about IRBs and the pandemic at a PRIM&R virtual conference, titled, “Research Ethics and COVID-19: Lessons Learned and Future Considerations,” held Aug. 18.

“We have to be creative, especially with IRBs that are a mix of clinicians and administrators,” Harley explained. “We have to make sure we’re being kind to ourselves and setting appropriate boundaries.”

As IRB staff continue to work partially or fully remotely, they need to differentiate between work hours and non-work hours. “Many of us are letting work hours bleed into our personal lives in a way that is challenging for everybody,” Harley explains. “We should put parameters or boundaries around work time, which is critical for an individual.”

IRB directors should emphasize the importance of being kind to colleagues. Everyone is experiencing stress and issues.

“We should try to communicate that we should always keep in mind that everybody is going through something right now,” Harley said. “There’s not a single one of us who doesn’t have a challenge or extra stress that we’re dealing with.”

Give Colleagues Space

As IRB staff and members communicate and hop on a call, there might be background noise of dogs barking, or their children could be climbing on their laps, or family members who need attention.

“Sometimes, we just need to give staff space to vent a little bit, so put in extra time at the beginning of a call or meeting to acknowledge them and the struggle they’re going through,” Harley suggested. “When people are curt or abrupt with us, it’s not necessarily personal; everyone is going through something, so just give them a little space to be where they are in that moment.”

Adjust Reopening Plans

As the pandemic’s first year draws to a close, IRBs should consider how to adjust plans for reopening and starting studies while keeping everyone safe. They also must prepare for a second surge of COVID-19 and pausing more studies.

“What we’ve done at Yale is there are a number of groups that are evaluating the safety, not just from a human subjects protection perspective, but also looking at the safety of staff, researchers, and everyone on our campus,” said Linda Coleman, JD, CIP, CHC, director of the HRPP at Yale University. Coleman also spoke at the Aug. 18 PRIM&R virtual conference.

Groups focused on the pandemic response began meeting in March. The institution established a hotline and evaluation of which types of studies needed to be paused and which could continue. “As we moved along, over time, we evaluated a phased-reopening plan with the understanding that if there is a surge in our area, then we might also have to ramp down again,” Coleman explained. “At that point, we had a phase 0, where the only type of studies that could remain open were those that were essentially therapeutic with potential for direct benefit, and even those were limited.”

Next was phase 1, which reopened a few more studies. The institution moved to a phase 2 and then phase 3, where more — but not all — studies are underway. “The key to phase 3 is you want to minimize contact among staff and research participants,” Coleman said. “We’re telling researchers that we’re in a phase 3, and they can use social distancing.”

The goal is for investigators to find different ways of conducting their studies by using telehealth visits and changing how they consent participants. They also can develop safer ways to conduct laboratory tests. “The key is always to minimize contact,” Coleman said.

The decision to change a phase is based partly on what the pandemic looks like in the area and the availability of personal protective equipment, she added. Phasing also is related to what the university campus is doing regarding in-person work and classes.

“Certain undergraduate students are allowed to come on campus, and some semester-long visitors are allowed on campus,” Coleman says. “Even though some expansion of on-campus activities is permitted in phase 3, other safety measures are in effect.”

Stay Connected

One of the more challenging changes during the pandemic is for IRB staff to stay connected. “It’s really important that IRB staff and IRB members check in on each other to make sure they’re OK,” Harley said. “IRBs are encouraging people to use emails and other tools to check in with each other and make sure people are communicating.”

As the pandemic continues, and especially if it resurges in an area, forcing institutions to put studies on pause again, IRBs should be aware of pandemic fatigue.

Every IRB member and employee will have a personal story about the pandemic’s emotional impact on them. For those in need of the emotional support of coming into the office and chatting with colleagues, the pandemic has been particularly difficult, Coleman notes.

Also, some employees are caring for small children or older family members at home during the pandemic. Balancing their home family life with work-at-home life is challenging. “The university has done a good job of addressing all those situations and giving employees flexibility,” Coleman explained. “If they have a sick parent at home and want to adjust their hours in the day, then as long as people know what’s going on, we can all be flexible.”

Remote workers tend to work longer hours. “Before, we would go across the street for a cup of coffee and would have to walk across the campus for a meeting,” Coleman said. “Now, we have to remind people to take a break before a meeting.”

Once IRB offices reopen with full, in-person staff, leaders should keep in mind there could be celebrations and excitement — but there also could be some shocking surprises, Harley says.

“Be prepared for how much people may have changed since they were last in-person,” Harley says. “Some might have gained a significant amount of weight; some might have lost weight; some might have aged.”

IRB co-workers also might have lost family members to the pandemic and are less cheerful and energetic than they were before offices closed. “We’ll have to be sensitive to any range of emotions that may come up when people start getting together again,” Harley said. “We need to allow people to come back without any shock, surprise, or judgment. Everyone is going through something, so they may look different and speak differently, and their perspective may be different.”

The IRB office and research organization also might look different. Some places will have new Plexiglas barriers and other infectious disease safety features, Harley said.

The organization can prepare workers by showing them videos before they return to work and sharing information about new rules regarding bringing in lunch and how conference room meetings might work, she added.