It wasn’t easy for Dr. Marty Mayfield to secure a promise from a friend and colleague to send him a small number of mice that exhibited clinical disease when infected with the coronavirus causing COVID-19 disease1. The colleague, Dr. David Raush, had been a lab-mate of Mayfield’s while they were post-doctoral scholars at Great Eastern University, where Mayfield still worked. The biggest hurdle had been assuring the safe transport of the uninfected animals to Great Eastern because an escaped mouse, even if not carrying the virus, would be a public health threat. Although that problem was resolved, an equally significant problem faced Mayfield.

Mayfield proposed to perform his mouse experiments at the ABSL-3 level and keep the SARS-CoV-2 coronavirus under BSL-3 conditions. But although Mayfield had proper past experience working under BSL-3 and ABSL-3 conditions, Great Eastern did not have BSL-3 or ABSL-3 facilities. Mayfield was well aware of this problem and with the knowledge of the school’s IACUC and Institutional Biosafety Committee (IBC) chairpersons, he had submitted IACUC and IBC applications to a nearby contract research organization (CRO) that had the needed biocontainment facilities and would allow Mayfield to use those facilities. Both of those applications had been approved by the CRO and now, following Great Eastern policy, the same approved applications were submitted for concurrence by the IBC and IACUC of Great Eastern University. The IACUC voted to agree with the CRO’s approval, but the IBC did not, citing inadequate containment if a mouse were to escape from its cage while at the CRO. The result was a de facto halt to the planned experiments.

Mayfield was livid, and after an informational phone call to OLAW he argued with the IACUC chairman that only one IACUC was legally required to approve a protocol application, and he already had that approval from the CRO’s IACUC. There was no need for any additional concurrence by the Great Eastern IBC, said Mayfield, especially after the Great Eastern IACUC agreed with the CRO’s IACUC and the CRO’s IACUC was in agreement with the CRO’s biosafety committee. The chairman brought the issue to the Great Eastern IACUC. What are the pertinent regulatory requirements for the Great Eastern IACUC to follow and would you support Mayfield or the Great Eastern IACUC?