The explosive growth in the use of genetically engineered mice (GEM) was nothing new to Great Eastern University. For several years, researchers at Great Eastern had been using transgenic, knockout, and other mice. As might be expected, the IACUC had previously discussed the use of tribromoethanol (TBE, Avertin), an anesthetic agent often used with GEM. Although there were reports in the literature of possible adverse side effects related to the use of this drug, there were other studies with contradictory findings. After having discussed the issue with the University's veterinarians, the IACUC decided to allow the use of the drug.

For years there were no further questions about TBE. The IACUC, as it did with other anesthetic agents, asked questions about the dosage, route of administration, and volume used, but nothing more. However, this attitude changed when Sylvia Stern, the chairwoman of the IACUC, was examining the policies of the USDA, which help to explain the intent of the Animal Welfare Act (AWA) regulations. She noticed that Policy # 3, “Veterinary Care”, stated that investigators are expected to use pharmaceutical-grade medications whenever they are available, unless the IACUC approves a non-pharmaceutical-grade product for reasons of scientific necessity. Stern knew, of course, that laboratory mice did not fall under the regulations of the AWA, but the Great Eastern IACUC had long ago agreed to follow USDA regulations for all species. She decided to raise the issue at the next IACUC meeting.

At the meeting, it became evident that most of the researchers formulated the TBE using the appropriate alcohol and distilled water (obtained directly from the building's distilled water supply), and then placed the resulting solution in a clean but not sterile vial. Most did not filter-sterilize the solution, claiming that it was unlikely that any common pathogen could survive in it. The veterinarians said that they knew of no in-house incidents that indicated any medical problems resulting from any of the preparation methods. The discussion centered around two related issues. First, it was quite obvious that most researchers did not want to change to another anesthetic, because the TBE was effective for them. The second issue was the Committee's own policy to use pharmaceutical-grade drugs when they were available. Clearly, alternative pharmaceutical-grade anesthetics were available, and the IACUC had heard no compelling argument that TBE was the only suitable anesthetic. How would you approach the problem facing the Great Eastern IACUC?

Response to Protocol Review Scenario: Take It Slowly

Response to Protocol Review Scenario: A Change Is in Order

Response to Protocol Review Scenario: Check the Records