Dr. Herb Birnbaum, working for a small biotechnology company, was studying the expression of the gene Brca1 in mice that had malignant ovarian tumors, mammary tumors or both tumors implanted subcutaneously. The goal of the study was to maintain the animals in good health as long as possible and to determine whether Brca1 was overexpressed in animals that had both tumors, as compared with animals that had only one or the other. Birnbaum contracted with Great Eastern University for animal housing, care and procedural space. Birnbaum's own technicians carried out the experimental procedures. His protocol had been reviewed and approved by the Great Eastern IACUC.

About halfway through Birnbaum's study, Dr. John Brown, the Attending Veterinarian at the university, was approached by a new investigator and asked about the appropriate dosage of cisplatin (a chemotherapeutic drug) for rats. Brown was aware of other rat studies that had used cisplatin, and he quickly provided the investigator with the dose that had been used on those studies. He also reminded the investigator to have the drug's use approved by the IACUC and the Chemical Safety Committee before using it in any ongoing study. The investigator was surprised that he had to do this because Herb Birnbaum was using the drug in his Brca1 study with only the approval of his own company's Safety Committee. Brown was shocked to hear this, but Birnbaum soon confirmed that it was true. Birnbaum did not think he had done anything wrong. In fact, as he pointed out, he clearly wrote in his protocol that his mice would be given standard care for their tumors. To Birnbaum, 'standard care' meant the use of cisplatin, which is often used in human patients with ovarian cancer. To Brown and the Great Eastern IACUC, 'standard care' meant observing the tumors for ulcerations, placing food on the cage floor if necessary and other similar non-medical interventions. To complicate matters, Birnbaum reminded Brown that he had sat through an hour-long lecture on rules and regulations, in which Brown often commented on the importance of 'performance standards' that provide flexibility based on the needs of the animal and the study, rather than more rigid engineering standards. Brown had also spoken of 'practice standards', which included the use of procedures considered by professional judgment to benefit the animal. Birnbaum claimed that cisplatin was used to help the animals in his study to remain healthy.

There was an obvious breakdown of communication between Birnbaum and the IACUC. What immediate steps should the IACUC take in this case, and what should the IACUC do to prevent problems such as this one from recurring?

Response to Protocol Review Scenario: Revise protocol form

Response to Protocol Review Scenario: A word from OLAW

Response to Protocol Review Scenario: Specify all medications

Response to Protocol Review Scenario: Describe in detail