Implications to IRB Operations Due to the COVID-19 Pandemic
What is the impacts of human subject protections and IRB operations during a time of crisis such as the COVID-19 pandemic? This has been a question at the top of the minds of anyone conducting clinical and translational research over the past three months. What can and should be done?
Nearly a month ago, we joined a Society for Research Administrators International (SRAI) “virtual happy hour” to discuss with colleagues the implications of the COVID-19 pandemic on Institutional Review Board (IRB) operations. We not only wanted to help and offer advice, but also wanted to learn and hear from others what they were going through during this time.
The discussion began around questions regarding the transition to remote follow-up visits for existing research protocols, and if this required submission of protocol modifications to the IRB. We indicated that there was purposely some flexibility in the regulations for situations like this. The regulations allow for changes to the protocol to be taken without prior IRB review in order to eliminate an apparent immediate hazard to a subject. If a change for this reason would occur, the IRB would want to be informed that the change happened. Investigators should also review protocols, and if in the original protocol it does not specify where visits should take place (i.e. specify in person study visits), then there can be flexibility in terms of switching to virtual visits without a protocol modification. Clinical follow-up visits should be shifted to virtual visits when possible. Therefore, utilize regulatory and protocol flexibility when possible for clinical research visits. Next we discussed potential associated consent changes. We concluded that a revised consent is only required when the original fundamental consent of a participant is impacted by changes. Minor changes in study visits, like changing to remote visits, would not likely rise to that level and can be communicated to participants without the need to re-consent or submit a consent modification.
IRBs experienced significant increases in modifications or amendments to existing research protocols to add COVID-19 related data collections for research purposes. These were instances whereby these data were not originally contemplated in protocols, but now changes to the protocols were necessary in order to gather data during this unique, transient period of time during the pandemic. This was the main cause for additional work and temporarily delays in IRB operations, as more protocol changes were submitted for review. We recommended transparency related to temporary slowdowns in operations were necessary. Thus, let investigators know that IRBs were experiencing higher review volumes and provide estimated turnaround times.
We found that not as many new protocols were being submitted, at least during this first six weeks of the shift in operations to virtual IRBs, and that there was not a rush on reliance agreements or collaborative protocols, yet. However, we speculated that the latter might still be coming as we heard that at one institution there were 22 collaborative COVID-19 protocols planned for submission for extramural funding agencies. Full board IRB meetings went virtually, and in general, without complications. Actually, in some instances, IRB attendance and participation increased during the virtual IRB meetings.
Most IRBs had added the following support services: 1) More educational sessions for investigators and research teams on how and what to submit to the IRB; 2) More virtual office hours for IRB assistance to investigators and their teams; and 3) An increase in email news updates. Not all investigators liked the increased email communications. Feedback to IRBs was to increase quality of communication over the quantity for investigators.
|Philip A. Cola, PhD, Associate Professor of Management
Case Western Reserve University
|Madeleine Williams, MA, Senior Director
Huron Consulting Group