I think a baseball analogy perfectly describes the clear lack of responsibility on the part of the principal investigator (PI) Linder. The IACUC, as reported, gave her three chances to respond to notices that her protocol was nearing expiration. As PI, Linder is solely responsible for making sure that she is compliant with all regulations. Unfortunately for IACUC Chair Covelli, the 'pain' does not end here.

Because Linder did not respond promptly to the IACUC notification, her protocol is no longer approved. If her research is federally funded, then her non-compliance must be reported to the Office of Laboratory Animal Welfare (OLAW) in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (section IV.F.3)1. In addition, Covelli is incorrect in calling the protocol a holding protocol with the IACUC as PI. This is not an acceptable interim solution. An individual (possibly the facility director or veterinarian) can submit a new protocol to maintain the animals until a decision can be made about Linder's animals, in the hope of salvaging the mice as part of the research study.

Covelli acted ethically but not swiftly enough. He should have brought the issue to the IACUC immediately after the protocol expired to address the non-response by the PI and the possible reassignment of the mice to another individual PI. I also think that Covelli should be in contact with the Institutional Official (IO), as Great Eastern now needs to contact OLAW and the funding agency. Linder has shown disregard for the IACUC, the institution and the animals themselves. She was given ample opportunity to submit a revised protocol; by ignoring the IACUC, she has created a completely unnecessary and avoidable situation. The IO should be concerned about Linder's commitment to ethical research, compliance training and responsibility to the university and granting agency. The probable euthanasia of the mice (loss of precious research resource) should be a large motivator for Linder; she, Covelli and the IO should meet to discuss a solution.

Research is a collaborative process that includes the PI, the IACUC, the animals and all the staff caring for them. All participants, especially the PI in this case, must accept responsibility and act ethically, or the process may break down. One could argue that IACUC did not do enough to notify the PI (possibly a phone call was warranted in addition to the three notices, warning Linder of the consequences of her inaction), but PIs must be held responsible for their obligations. Maybe for the future, Covelli, the IACUC and the IO could include training for PIs to inform them that non-compliance can have negative consequences for the animals, the university and the people involved.

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