The More ≠ the merrier

In this scenario, both institutions must have a properly constituted IACUC in order to approve research activities in accordance with the Animal Welfare Act and Regulations¹ and the Public Health Service Policy on Humane Care and Use of Laboratory Animals². We assumed that both institutions were registered with USDA APHIS and that both had Assurances with OLAW.

OLAW states that inter-institutional collaborations “have the potential to create ambiguities. Therefore it is imperative that institutions define their respective responsibilities³.” The Guide for the Care and Use of Laboratory Animals recommends that “the participating institutions… have a formal written understanding (e.g., a contract, memorandum of understanding, or agreement) that addresses the responsibility for offsite animal care and use, animal ownership, and IACUC review and oversight⁴.” The formal written understanding between the two institutions in this scenario was a memorandum of understanding (MOU).

When Little Eastern College modified the protocol using the veterinary verification and consultation (VVC) process, it overstepped its authority with respect to the MOU. This is because, according to OLAW guidance, VVC is a review process for significant changes, though they are specific and may be handled administratively, with the veterinarian serving as a subject matter expert⁵, and the MOU stated that both schools were responsible for reviewing and approving the protocol for the work to be performed at Little Eastern College. However, “OLAW and APHIS agree that review of a research project or evaluation of a program or facility by more than one recognized IACUC is not a federal requirement³.” Therefore, while Little Eastern College was incongruent with the MOU it established with Great Eastern University, no federal requirements or laws were violated.

The institutions may have been able to avoid this situation if the terms of their MOU had been different. “If both the awardee institution and the performance site institution have Domestic Assurances, they may exercise discretion in determining which IACUC reviews animal activities and under which institutional program the research will be performed. There is no requirement for dual review; IACUCs may choose which IACUC will review protocols for the animal activities being conducted,” according to OLAW guidance on inter-institutional collaboration³. Furthermore, “it is recommended that if an IACUC defers protocol review to another IACUC, documentation of the review should be maintained by both committees. Additionally, the IACUC conducting the review should notify the other IACUC of significant questions or issues raised during a semiannual program inspection of a facility housing a research activity for which that IACUC bears some oversight responsibility³.”

We would advise both institutions to modify their MOU to delegate Little Eastern College as the IACUC responsible for reviewing protocols and animal activities at that institution, with the stipulation that Great Eastern University be provided a copy of all protocol documentation. Doing so would reduce regulatory burden as well as resolve such ambiguities as were observed by the USDA site inspector.