Both institutions have acted in good faith, but there is clearly confusion regarding the responsibility and authority of each institution in this scenario. They would do well to consider the following statement from the Guide for the Care and Use of Laboratory Animals (the Guide)1:

“Interinstitutional collaboration has the potential to create ambiguities about responsibility for animal care and use. In cases of such collaboration involving animal use (beyond animal transport), the participating institutions should 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 oversight. In addition, IACUCs from the institutions may choose to review protocols for the work being conducted.”

In our opinion, this situation does constitute noncompliance. As outlined in the scenario, the New Antigen IACUC approved rats to be housed at Great Eastern until transported to New Antigen for euthanasia. There is also a protocol approved by the Great Eastern IACUC for New Antigen mice to be housed at Great Eastern and for all procedures to be conducted there, with no provision for transport to New Antigen for euthanasia. The fact that New Antigen's IACUC subsequently approved its own protocol allowing mice to be transported to New Antigen for euthanasia does not alter the Great Eastern protocol. Therefore, it appears that transporting and euthanizing mice at New Antigen was not in accordance with the Great Eastern–approved protocol.

The criteria established for reporting incidents of noncompliance in the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy)2 include any serious or continuing noncompliance with the PHS Policy, any serious deviation from the provisions of the Guide and any suspension of an activity by the IACUC. OLAW has also released examples of items that are considered reportable3, and this list includes conduct of animal-related activities without appropriate IACUC review and approval and failure to adhere to IACUC-approved protocols. Although the situation does not meet the criteria outlined by the PHS Policy, we feel the institutions should plan to report the incident to OLAW.

In our opinion, the responsibility to report lies with Great Eastern University as it was there that the noncompliant procedures (transport of animals) were initiated. However, if Great Eastern's Assurance with OLAW states that only incidents associated with NIH-funded research will be reported, then the university will need to determine whether these mice were used on an NIH-funded study. If Great Eastern University is accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC), International, then it should report the incident to this organization also. Because the incident involved mice, there is no need to report to the USDA.

To prevent future occurrences of miscommunication and noncompliance, we recommend that Great Eastern University and New Antigen Inc. develop a formal written understanding that addresses their relationship, including protocol review.

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