IRBs Must Review Study Protocols Rapidly and Ethically During Public Health Emergency
September 1, 2022 3 minutes read
In 2014, when U.S. nationals were repatriated for treatment of Ebola virus, some IRBs took a hard look at their existing processes. “We recognized that typical IRB review could impose delays on the provision of investigational drugs to these ill patients,” recalls Bruce Gordon, MD, assistant vice-chancellor for regulatory affairs and executive chairman of IRBs at University of Nebraska Medical Center.
It was apparent the time-consuming IRB review process could slow researchers, to the point where the window for conducting meaningful research on an emerging infectious disease closes. “There were a lot of calls for processes, but there wasn’t anything out there. We saw that problem, and needed to find a solution for it,” says Abigail E. Lowe, MA, director of ethics and public health preparedness at University of Nebraska Medical Center. At that point, there was not a strong consensus on the need to find a way to speed IRB review during a public health emergency. “We almost had to explain why we had to do it, and convince people that it was important,” Lowe says.
Ultimately, the University of Nebraska developed a single IRB with the goal of serving as a resource for rapid, ethical review of clinical research on emerging pathogens. Recently, Gordon, Lowe, and colleagues conducted a series of preparedness exercises to develop and test this model.1 The overarching goal was to see if the single IRB review of multisite research could be conducted in 72 hours. “We were able to get [a study on] remdesivir through IRB approval within 72 hours,” Lowe reports.
The entire process hinges on excellent communication among everyone involved. “The loop between research coordinator, IRB administrator, and researcher becomes so much more important when you are trying to accomplish something quickly,” Lowe explains.
For this to work, IRB review must be efficient yet thorough. The group found ways to prevent delays. For example, when IRBs ask for a modification to the study protocol, it typically sits in someone’s inbox for a period before anyone acts. “Maybe we can have the researcher on standby to answer questions,” Lowe suggests. “Or administrators can be more involved to make sure that we are catching things that are not clear in protocols.”
For instance, IRBs may just want to know at what point researchers are going to obtain informed consent. The back-and-forth it takes to receive an answer delays the process. Ensuring details like that are included in the study protocol prevents this time-wasting.
Conducting clinical research during an infectious disease outbreak takes careful planning and coordination, not just for researchers and study teams but also for IRBs. “If it works, it doesn’t just happen. It’s because you planned for it,” Lowe says.
How communication happens among everyone involved and who is responsible for all portions of the process must be settled in advance. “A lot of times, the research coordinator is responsible for corralling the principal investigator and getting back to the IRB,” Lowe says.
To speed that process, research coordinators are more proactive. Knowing exactly who to talk to at the various research sites about a requested modification stops delays caused by emails sent to the incorrect contact. “You want to avoid getting into a holding pattern,” Lowe says.
It also is important to find out about anything at the various sites that can cause delays. “We asked, ‘If we had a study drug to evaluate right away, what would the steps be at your institution? What are the ancillary reviews that happen at your site that might hold back the study?’” Lowe recalls.
In one case, the site required the study to go through pharmacy and therapeutics (P&T) review. The problem was the committee met only once a month. Thus, the team created a new process. If the Rapid Response IRB was initiated, the P&T committee also convened quickly with a review. That way, the study would not be delayed for weeks waiting for the next scheduled meeting.
“Coordinating with the single IRB is only one part of the program,” Lowe says. “It’s not just: ‘Is your IRB review done?’ but also whether the really crucial reviews are done that will allow you to release the study.”
REFERENCE
1. Lowe AE, Kraft C, Kortepeter MG, et al. Developing a rapid response single IRB model for conducting research during a public health emergency. Health Secur 2022;20:S60-S70.
Conducting clinical research during an infectious disease outbreak takes careful planning and coordination. The entire process hinges on excellent communication among everyone involved.
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