IRB Advisor: What have been the most challenging changes your IRB made because of the COVID-19 pandemic? How did you handle them?
Moore: We have faced multiple challenges during the COVID-19 pandemic; some have been with the conduct of IRB activities, while others have been assisting study teams and investigators with transitioning their study activities to new study methods due to physical distancing requirements. Virtual IRB meetings through video and teleconference have been used consistently. This technology was used already for unaffiliated members, but was used more widely to achieve and obtain quorum during restricted and alternative work hours.
Doksum: We conduct mostly social-behavioral research. One of the first changes we made was to develop guidance for studies that involved face-to-face data collection (e.g., interviews, focus groups) — indicating they should switch to virtual modes (e.g., phone or web-based) or voluntarily pause. Most of our studies already were collecting data virtually, so only a subset of active studies were affected by the pandemic. The challenge was that the pandemic quickly evolved, so our guidance had to change with it. After a few weeks, we updated our guidance to require an exception request for face-to-face data collection. Fortunately, we were in frequent communication with peer IRBs to ensure our guidance was staying current with best practices.
Anding: Our office has been working hard to stay one step ahead of the changing landscape because of COVID. I’ve been involved from the IRB staff and members’ perspective. Another colleague, Catherine Rogers, has done a significant amount of work with researchers and various institutional groups monitoring clinical research initiatives surrounding COVID.
Cholka: One of the biggest challenges our IRB faced was communicating to our researchers the difference between changes to research that reduce immediate hazards to participants and changes to research related to COVID-19 that require an amendment prior to implementation. To communicate with our researchers, we partnered with other components of our HRPP [human research protection program] to ensure we informed as many researchers as possible. These additional communication paths will be used after the crisis is over, because these paths strengthen our communication efforts.
Reuter: BRANY IRB meetings have been occurring via teleconference for several years, so our committee members made a seamless transition in response to physical distancing requirements. Several members of our IRB staff also had experience with telecommuting on occasion, and were equipped with laptops and the proper software to work remotely. Our biggest challenge was to transition a few IRB staff who had worked predominantly in the office up until that point to a remote working environment. We worked swiftly to provide them with the equipment and support they needed to work from home. A new strategy we employed was the use of a software application that allows for instant messaging, screen-sharing, and conferencing to facilitate communication outside of email, and we created several different groups based on certain projects or themes to keep communication flowing. This has been useful, and may be a useful tool even after the crisis is over and we return to the office.
Williams: Like all IRBs, the Salem State IRB shifted to online meetings to accommodate the pandemic. I anticipate we will continue to offer that as an option in the fall. Because faculty were asked to alter their course delivery online so quickly while also managing multiple personal priorities, the university issued a hold harmless statement for continuing scholarship. For some faculty, the social distancing order has given them the opportunity to increase their research, but for others, it has created significant stress to find the time around their teaching responsibilities. We also have had multiple faculty submit COVID-19 social-behavioral research projects, with an intense urgency for approval as the situation constantly changes.
Rogers: The most immediate challenge that comes to mind is the pace of information and how quickly that information can change, even from hour to hour (although that is slowing a bit now — until we gear up for re-entry, at which point this will start again).
Newlin: For COVID-19 treatment trials, applying the criteria for approval, and figuring out appropriate renewal periods, in an environment where the science is changing on a daily — sometimes hourly — basis has been an interesting challenge. For instance, our IRB was assessing an investigator-initiated treatment trial at the exact time when it was expected that the Food and Drug Administration (FDA) would issue the emergency use authorization (EUA) for remdesivir. Remdesivir was not yet the new standard of care, but it could be at any moment, or the EUA could have never come through. I was refreshing the FDA news and Gilead website every minute while IRB deliberations were taking place. When juggling assessments of clinical equipoise in that environment, all you can do is hold a lot of IRB meetings, have very tight data safety monitoring schedules built into the protocol, and pay a lot of attention to the news.
Since our institution was at the epicenter in New York, new studies came quickly, and in volume. An institutional challenge was to create an infrastructure to sort through which studies should move forward, which investigators should team up (if they had similar ideas), and which should wait for further down the road. Since all research goes through the HRPP, many researchers came to believe that we controlled this sorting process, when it was actually an administrative process outside of our office. But when the HRPP says “We can’t review this because it needs approval from X group beforehand,” the research community mistakenly thinks of the IRB as the delay. Spending time trying to explain that over and over has been a challenge.
Rigtrup: At the University of Utah, we are fortunate in these challenging times to have a director who holds a PhD in public health. Our IRB anticipated some of the actions we would need to take in preparation for social distancing, shutdowns, and the need for rapid study application turnaround times. We swiftly prepared and enacted several changes over the course of just a few days as we kept a close eye on global events and discussions from our institutional leadership.
DiMario: We created a set of guidelines for researchers and widely distributed them prior to implementation. We halted non-therapeutic or non-safety-related, in-person interactions with participants. As a corollary, we advised that if possible, principal investigators implement virtual study visits and submit planned study deviations, as opposed to a long-term study amendment to the IRB. This impacted study sample collection for non-safety-related collections, as well. If the PI wishes to continue this procedure long-term, then they will inform the IRB with a subsequent amendment.
McGee: We basically followed directives on social distancing. The university paused research that cannot comply with the directives. The exception is some research that could provide important information about treatment and prevention of COVID-19 and some research that provides direct benefit to participants or that would be a risk to suspend. We still process applications, modifications, etc. We all work from home and hold IRB meetings via Zoom.
Smith: Fewer of my studies have been impacted than most IRBs. A lot of survey/interview studies had to find ways to continue, but we had vanishingly few treatment studies that still were recruiting or treating participants. Most of them had wound down or had yet to begin those stages. So far, the biggest challenge has been getting investigators to think through the alternative logistics of doing their entire or remaining portions online.
IRB Advisor: Were there any new tactics or workflow processes that your IRB developed because of physical distancing challenges? Are you considering keeping these changes after the crisis is over?
Newlin: We were fortunate to be already set up, very well, to work remotely. Our IRB switched to a flex model, all over Zoom, in 2014, and we have a very good and reliable electronic system that is available online. I expect we’ll allow for more remote work in the future. We had been one or two days per week for experienced managers, but at this point, we are going to have to get used to long-term remote working. That will likely be available even if we do head back to the office at some point. One of the immediate challenges, even though we are well set up for remote work, is that no one expected to be working remotely 100% of the time, with all their family members at home. We have team members working on ironing boards as standing desks, kitchen tables, wherever they can find a quiet space.
Figuring out how to get everyone set up with everything they need at home is our immediate ongoing challenge, and it will probably be a part of the job for the long-term future. Team members may come to a physical office, but they will need a parallel, equally functional work space at home. Many of us don’t have that dedicated office at home, so we need to find a way to create one.
DiMario: We have maintained daily virtual meetings and continued to work remotely. The positive result has been a more efficient virtual conversation as we practiced over time. The real negative impact with a return of normal operations will be the added family stress placed on those with school-aged children who may be continuing to attend virtual school at home. We may simply continue virtual meetings and more remote work activities.
Rigtrup: The most urgent thing we addressed was the need for transitional instructions for our research community as remote working requirements were implemented. We quickly issued a public statement that included guidance for investigators about how to prepare their existing research for COVID-19. (The guidance is available at: https://irb.utah.edu/about/news/2020/irb-covid19-communications.php.) The guidance included assurances the IRB would be fully operational throughout the crisis, and instructions for incorporating remote consent processes and virtual study visits into their approved protocols wherever prudent.
At the same time, we prepared our staff at every level for transitioning to remote working, which included quickly ordering supplies and any videoconferencing equipment our staff and board members might need for their home workstations while shipping speeds were still operating as expected.
We also developed and issued evolving guidance, procedures, and policies as needed for conducting virtual convened board meetings, a topic we had already been researching before the health crisis began. We plan to continue to use this format for some of our meetings in the future.
Moore: Our researchers and study teams are hardworking and diligent when it comes to the safety of study participants. However, many were unfamiliar with acceptable alternative methods of obtaining consent and conducting study visits. A significant amount of education has taken place for research to continue. Many investigators can continue their research from a remote setting, and have indicated they will continue these methods even after the physical distancing restrictions are lifted.
Rogers: In the early stages, frequently asked questions that were posted almost immediately needed revision as the landscape changed, or new ones were drafted as new questions arose. The quick pace also has meant things that under normal circumstances may take months are now happening in a matter of days. For example, developing a complicated workflow to obtain plasma from convalescent COVID patients, which involved collaboration between at least four different entities on campus, came together in a matter of a few weeks. This also fostered an environment of consistent and productive communication between groups that I hope will last beyond the pandemic. Additionally, the pandemic has highlighted the need for the university to have adequate software to obtain e-signatures, something that is not just applicable to the current pandemic. The immediacy of the current need, though, means that this is being fast-tracked in a way that it might not have otherwise.
Reuter: BRANY assisted numerous sites as they grappled with changes to their research. Most institutions issued guidelines that affected the research team’s ability to carry out their study procedures or visits as per protocol. This resulted in many protocol deviations, and the need for protocol amendments. Sites also were receiving correspondence from sponsors regarding accommodations for protocols, such as remote study visits and shipping study drugs directly to the subjects’ homes. Coordinators were uncertain about whether this correspondence needed to be submitted to the IRB, or if the deviations needed to be immediately reported. BRANY swiftly issued guidance on how to deal with these rapidly developing changes, and clarified what changes qualified as “necessary to eliminate apparent immediate hazards to the subject,” consistent with FDA guidance. Changes were quickly made to our electronic submission forms and processes to accommodate new types of submissions. Most importantly, BRANY staff was immediately available to answer questions and guide sites through the process.
Doksum: The only new workflow process was creation of a special review committee for requests for an exception to our policy of pausing face-to-face data collection. This special committee includes representatives to provide input on staff safety, which is an important priority for our company. We have yet to meet because all studies paused face-to-face data collection due to local restrictions. However, now that some parts of the globe are lifting restrictions, we are preparing to review studies that want to unpause or start new in-person data collection.
Williams: We have asked researchers to switch their data collection methods to videoconferencing rather than in person. We also have issued many pending approvals for students in clinical studies, such as social work and occupational therapy, who were unable to secure clinical research collaborations due to the pandemic. We do not anticipate that these practices will continue, but also understand that the pandemic is new to all of us and we must be flexible in our practices and institutional procedures.