In response to the issues posed in this scenario, the US Department of Agriculture- Animal and Plant Health Inspection Service (USDA-APHIS) and the National Institutes of Health-Office of Laboratory Animal Welfare (NIH-OLAW) provide the following clarifications:

In this scenario, two institutions are collaborating on research with deer mice under a Memorandum of Understanding (MOU). The MOU requires both Institutional Animal Care and Use Committees (IACUCs) to review and approve the protocol for the work. When a significant change is necessary, the IACUC where the work is conducted fails to inform the other institution’s IACUC of the change made using veterinary verification and consultation (VVC).

USDA response

The review and approval of significant changes is an IACUC function1,2. At least one IACUC that is party to the MOU must carryout the IACUC functions to meet the Animal Welfare Act regulatory requirements. Although USDA encourages research facilities that contract studies to determine and document which party is responsible for the functions of the IACUC, animal care and handling, and the reporting of animals on the Annual Report, there is no regulatory requirement that this occur. In the context of an animal welfare compliance inspection, USDA focuses on whether an IACUC carried out the necessary review and approval of the significant change as required by the regulations, not the division of responsibilities described in the MOU. With that said, the implementation of the significant change by one IACUC without informing the other was not consistent with the MOU.

OLAW response

As noted by other reviewers, review of a research project by more than one recognized IACUC is not a federal requirement3. However, failing to inform the MOU partner of the significant change to the protocol is not in keeping with the MOU. OLAW does not consider the failure to follow the agreement in the MOU a reportable incident. Concerning the use of VVC in this scenario, if the IACUC’s VVC policy allows changes in anesthetics which include inhalants and if the proper safety and training issues are considered, VVC is an acceptable option4.