It is important to note that the policy on which this issue is based is a university-established regulation at Great Eastern, not a specific federal mandate. While it is the responsibility of the research facility to ensure that all are qualified to perform their duties and that personnel conducting procedures on the research animals are appropriately qualified and trained in those procedures, there is no federal requirement that only a university employee can be a PI on an approved IACUC protocol. Thus, the former arrangement was compliant with federal standards as long as Schope is familiar with the research and qualified to function as the PI. However, because the PI is responsible for all aspects of animal care and use described in the protocol, it would be best for that person to be intimately associated with the experiments described in the protocol. In this particular situation, this is clearly not Schope. The key issue, therefore, is whether a balance can be achieved between appropriate animal oversight and compliance with university policies.

Another important point to consider is that IACUC policies need to be consistent in order to be credible. Reversal of long-standing policies simply because a new chairman deems them no longer acceptable sends a confusing message to the investigators and may prevent valuable research from moving forward. Nevertheless, the new IACUC Chair does have a valid concern in that the PI may not be appropriately familiar with the proposed research, and is listed as PI mainly to comply with a Great Eastern-established policy. One possible remedy that would enable the work to move forward while allowing for someone more familiar with the research to be responsible for the day-to-day monitoring and care of the animals is for the Great Eastern IACUC to consider the idea of co-PIs. Schope could serve as the university representative, along with a non-Great Eastern individual from the contracting company who is actually doing the work. Both would share in the responsibilities of monitoring animal welfare and, in this way, provide adequate surveillance of the animals, while still adhering to the Great Eastern policy.