The Transgenic Mouse Production Facility (TMPF) at Great Eastern University was a specialized unit for producing genetically engineered mice. It had a comprehensive IACUC-approved protocol to produce animals for faculty researchers. The protocol focused on the technical aspects of the procedures to be done for investigators (surgery, aftercare, genotyping and all other appropriate information). Typically, an investigator with an approved IACUC protocol would provide the TMPF with the required genetic and other necessary materials, along with information about the background strain of the mice to be produced. The TMPF would take over from that point, develop the genetically modified founder animals, genotype them, allow those with the appropriate genotypes to undergo one breeding cycle and then transfer the mice to the investigator. The investigator would breed and subsequently use the animals under his or her own IACUC protocols.

There was one potential flaw in the system that did not reveal itself until Dr. Richard Peskin had the TMPF develop a transgenic mouse for his research. The technical process went fine. However, Peskin forgot to submit breeding and research protocols to the IACUC. When he went to the TMPF to get his animals, the TMPF staff asked him for his IACUC approval number so that they could inform the animal facility that an animal transfer was being made. Recognizing his oversight but wanting to have his animals, he quickly wrote an IACUC protocol which stated that the animals were to be housed only and that no research or breeding would be done. Eventually, he stated in the protocol, the mice would be transferred to IACUC-approved breeding and research protocols. Peskin's 'holding' protocol was approved by the designated member review process, the business at the TMPF continued as usual, and Peskin soon submitted breeding and research protocols to the IACUC.

The TMPF director was a member of the IACUC and related the story to the IACUC chairman. The chairman was not particularly concerned, because everything worked out well. But is everything well? Was this just a one-time error on the part of an investigator, or are there deeper problems? Even though the TMPF works under its own IACUC-approved protocol, should it be allowed to produce mice for an investigator before the IACUC approves that investigator's breeding or experimental protocols? What are the potential consequences—if any—of the actions that occurred in this scenario?

Response to Protocol Review Scenario: Experimental protocols are essential

Response to Protocol Review Scenario: Approval spot-check

Response to Protocol Review Scenario: Risky assumptions