Employee Health Services (EHS) team swabbing mouth of individuals while staying inside vehicle to test for COVID-19. Team securing sample in biohazard bags to transfer to testing laboratory for results. (Photo by Ricardo Carrasco III)

The Keck School of Medicine of USC has established a process to rapidly evaluate research related to COVID-19 and open opportunities for care to clinicians and patients, according to a memo distributed April 4.

The new process will prioritize human-subjects research within Keck Medicine of USC. The goal is to foster teamwork across research and clinical care at a time when there aren’t any proven therapies for COVID-19, according to Tom Buchanan, MD, vice dean for research at the Keck School.

“Right now, every treatment is experimental; clinical care and clinical research are one in the same,” Buchanan said. “The prioritization process will allow the Keck School and Keck Medicine to make efficient and informed decisions about treatments to pursue in clinical trials.”

According to the memo, investigators across USC who are looking to conduct research at sites governed by the USC Biomedical Institutional Review Board (IRB) and involving patients with, or are at risk for, COVID-19 or their biospecimens must submit their requests to the COVID Clinical Research Prioritization Committee (CCRPC) through the COVID-19 Proposal Submission Portal. Submission to the committee should occur before submission to the IRB. Protocols that use a central IRB must be submitted to the CCPRC as well, ideally before submission to the central IRB but ultimately before they can be considered for implementation.

The CCRPC will evaluate the research proposals for scientific merit, potential benefit to patients, operational feasibility (including funding) and competing studies. Each proposal will receive a letter from the CCRPC indicating whether it should be prioritized for further consideration. The IRB will only review protocols that the CCRPC recommends for prioritization. The IRB submission for those protocols must include the prioritization letter.

The memo was signed by Buchanan; April Armstrong, MD, MPH, associate dean for clinical research and co-chair of the COVID clinical research committee; Michael Bowdish, MD, chair of biomedical research IRB; and Darcy Spicer, MD, co-chair of the COVID clinical research committee.

“We realize that this is not business as usual, but these are unusual times,” the memo stated. “Our health systems are severely stressed. Our patients and our society desperately need organized, coordinated, high-quality research to identify treatments that can improve health outcomes for patients infected with the virus that causes COVID-19.”

— Melissa Masatani