On October 15, 2020, PRIM&R hosted a webinar, IRB Operations During a Pandemic. During this webinar, Jeremy N. Block, PhD, MPP; Dorean J. Flores, BS, MPA, CIP; Hallie Kassan, MS, CIP; and Jon Newlin, CIP, focused on a number of critical areas of IRB operations during a pandemic. After the webinar, the presenters reflected on the session and attendee feedback; we’re pleased to share their follow-up with the readers of Ampersand.
Due to SARS-CoV-2 Pandemic, IRB administrators were thrown into an experience we had never encountered. It touched each and every one of us, regardless of type of institution, size of program, location, or type of research being conducted. It is important for us to come together to discuss issues encountered and solve the new challenges we encounter in our IRB operations together.
IRB Office Operations
The day-to-day operations of our office changed within hours. We were used to operating in an in-person environment and we had to be flexible and quickly shift to remote, ensuring that all staff were given access to computer systems and networks and able to function from home. While the landscape of our work environment was changing, it was more important than ever that we be functional and operating at 100%, due to the new virus. Even though everything about our work environment was changing, the most important thing needed to beat the pandemic was, and continues to be, research.
Keeping everyone connected and supported during this time was key to maintaining productivity. Strategies used included daily team video chats, use of Microsoft TEAMS for instant messaging and virtual happy hours to socialize.
Getting new SARS-CoV-2 studies started and maintaining the continued conduct of on-going studies were both priorities for the IRB office staff. For new studies related to the pandemic, our office established new expedient turnaround times that were transparent to researchers. This was possible to do since research not related to the pandemic was being put on hold. In addition, being transparent with turnaround times prevented constant calls and emails asking when a response would be received. For expedited studies, the IRB provided review within two business days. Studies requiring full-committee review were assigned to the next available agenda, which was never more than one week from the time the study was received by the office. In addition, our institution established some research oversight committees to determine which studies related to the pandemic moved forward versus which did not. IRB staff worked closely with these committees so we could prepare for the submissions we were receiving.
As vaccinations become more widespread and now that we understand ways to contain the virus, IRB offices will need to examine what the new work model looks like. Will you require staff to return full time? Can an office be sustained fully remote? Or might there be a hybrid model going forward, as most offices have probably found that there is not a great need for staff to be in an office setting.
IRB Protocol Review
Protocol review remains challenging in a quickly evolving scientific landscape with a still relatively new disease and new genetic variations now making large impacts across global populations. It sometimes feels impossible to keep up-to-date with even a fraction of the new science on the disease, and IRB’s will continue to adapt to making decisions without as much information as they might like. With science changing so rapidly and “standard of care” being updated accordingly with new evidence-based therapies, IRBs will have to continue to assess closely whether clinical equipoise exists between competing arms of treatment trials and if use of placebos is justified.
One particularly useful resource is CDC’s COVID-19 Science Updates, released every Tuesday and Friday.
Another useful resource, mixing science with a bit of humanity, has been the podcast series Osterholm Update: COVID-19, by the epidemiologist Michael Osterholm.
At our own IRB, we continue to use shortened renewal periods for COVID-19 treatment trials, increased data safety monitoring, and have seen a need to “hold the line” on equitability of subject selection, particularly around the inclusion of pregnant women. There is a temptation to ease up on the typical IRB operations during the pandemic, but IRBs should review protocols according to the Belmont Principles and regulatory criteria for approval just as they would pre-pandemic without cutting corners.
IRB Meeting Operations
We continue to utilize and be an advocate for the flex IRB model. Having one roster with all IRB members listed and scheduling frequent small meetings have allowed COVID-19 research to be reviewed quickly and without the need to schedule excessive ad hoc meetings. It also has allowed easy cross-pollination between IRB groups as the ebbs and flows of the pandemic have wreaked havoc on many clinicians’ schedules. Interestingly, our HRPP office was concerned about not having availability of infectious disease specialists during the pandemic, but that has not turned out to be the case. Though swamped, everyone recognizes the need to get more answers, and even the busiest of physicians and IRB members are taking time out of their schedules to complete effective reviews and participate in IRB meetings.
Recruitment and Consent
Recruitment into studies shifted from primarily in-person to remote with documentation of consent shifting from paper-based to electronic in an effort to control the spread of the infection while continuing research operations. IRBs were also challenged with streamlining source documents and providing various options for researchers to maintain regulatory compliance within an environment in which urgency was of vital importance.
It was imperative to have operating systems which were vetted and ready for use to e-consent to avoid the stopgaps in the research process and to provide the necessary support to advance research; however, even with this foresight, institutions across the United States, including our own, did experience one major hinderance—the availability of a Part 11 compliant e-consent system for use at the time of the pandemic. As a result, processes previously established to permit remote consent utilizing an altered process were executed to appropriately document research participation; and workarounds were developed to address various case scenarios unique to COVID-19 such as instances in which signatures could not be physically obtained in real-time from either the research participant and/or their legally authorized representative as a result of infection control procedures. This challenged IRBs to delve deeper into the regulations to identify areas of flexibility and utilize them to the fullest extent allowed by law with the overarching goal of being fluid to support operations while maintaining compliance.
Misconduct & Deviations – Identifying Misconduct, Handling Deviations
In the months and years ahead, we will discover misconduct that occurred during the pandemic. In the near term, institutions should be looking at threshold questions they can ask researchers as protocols restart to identify potential misconduct and differentiate it from errors and deviations. The research community will not look back at the pandemic without scandal. Expect it.
With vaccinations receiving Emergency Use Authorization, tens of thousands of participants were unblinded in placebo-controlled vaccination trials. These participants are now being crossed over and receiving the vaccine. Interestingly, some of them are getting the vaccine after they qualified for it based on where they live. This delayed access, under normal circumstances, is a deviation in studies that did not explicitly tell participants this may occur. Boldly, I think this should not be a UPIRTSO determination unless the delay is extreme and instead would strongly urge that IRBs evaluate this type of thing on a case-by-case basis.
As sovereignties move forward with their vaccination efforts, so too will we see restarting of research activities worldwide. This means reckoning with the plurality of studies that simply never were able to account for the pandemic. A regulocrat approach to this, assessing them all with deviations and UPIRTSOs, is a mistake. IRB’s are better served taking a capabilities and collaborative approach to restarting research by providing pre-defined perspectives on handling a large number of repeated issues the pandemic created; many of which we covered in the protocol amendment form designed to address pandemic-related changes. A similar restart process to the one we described for adapting studies during the pandemic will guide IRB’s and researchers in an orderly and ethically defensible process for reviewing and restarting research. Doing so will maintain the critical protections participants need in such uncertain circumstances.
None of this will be easy, and all of it is necessary.
PRIM&R thanks Jeremy N. Block, PhD, MPP; Dorean J. Flores, BS, MPA, CIP; Hallie Kassan, MS, CIP; and Jon Newlin, CIP, for sharing their expertise. The recording of this webinar (and recordings of other past PRIM&R webinars) is available for purchase in our Knowledge Center.