Mark Brantly, MD ’79, and his team of 11 physicians, study coordinators and lab staff are working day and night at the UF College of Medicine to evaluate a treatment for the novel coronavirus that might block the deadly inflammatory response caused by the disease that curtails the lungs’ ability to function.
nder normal circumstances, it can be a slow process, with thousands of other studies in line in what is a first-come, first-serve undertaking. In some cases, it can take a couple of months for approval.
Brantly’s approval came in five days.
The University of Florida Institutional Review Board, a committee consisting of 21 physicians, nurses, pharmacists, researchers and community members, approves all clinical trial protocols. This ensures federal, state and local rules and guidelines meant to protect patients’ rights and safety are followed.
“It was really done in record time,” said Brantly, a professor in the division of pulmonary, critical care and sleep medicine and the department of molecular genetics and microbiology. “That is the fastest I’ve seen it done in my career.”
This wasn’t happenstance. It’s by design. Amid the worst public health emergency in a lifetime, university leaders have taken steps to speed novel coronavirus research, recognizing the desperate need to provide answers and options to the communities they serve. Two key components of this effort: IRB retooling its approval process for coronavirus trials and the UF Clinical and Translational Science Institute, or CTSI, setting up a $2 million pilot research fund available to scientists with translational projects that can be rapidly mobilized.
“UF Health researchers, like Dr. Brantly, are working tirelessly on innovative approaches to combating the novel coronavirus,” said David R. Nelson, MD, senior vice president for health affairs at UF and president of UF Health.
“We need to better understand the virus, search for new treatments and bring them from the bench to the bedside as rapidly and safely as possible,” he added. “To that end, we want to provide all the support we can to our scientists and staff to promote a rapid response to a health emergency unrivaled in modern times.”
The Institutional Review Board’s response to a pandemic
At any one time, hundreds of study protocols might be in the pipeline for IRB review. So, the board is streamlining the approval process by pushing coronavirus research to the front of the line, without sacrificing proper regulatory review or patient safety.
“It’s like when you go to Disney World,” said Peter Iafrate, PharmD, who has served as chair of the IRB for the UF Health academic health center since 1996. “If you stand in line, you can be there for two hours. If you have the right pass, you get right on. No matter how long you wait, the ride you get is the same. Once the IRB reviews the study, no shortcuts are taken.”
The full IRB is now meeting weekly via Zoom, rather than following its traditional biweekly schedule, Iafrate said. He is now spending up to 80% of his time reviewing COVID-19 projects.