Maurizio Marchetti's research involved understanding the evolutionary significance of biochemical pathways leading to different phenotypic expressions of drug metabolism. To help explain the type of research he did, he used the example that onions can cause a severe hemolytic anemia when consumed by dogs. “Why did that trait evolve?” Marchetti would say. “Dogs aren't pure meat-eaters; they eat all kinds of food. Why did they evolve having a toxic reaction to onions?” So it was not surprising for the Great Eastern University IACUC to see a protocol from Marchetti that included mice, dogs and rabbits. In fact, it was quite typical for Marchetti's research.

During the course of one of his studies, Marchetti was informed that he had used nearly all of the dogs that the IACUC had approved. The original approval was for 50 animals, which Marchetti had calculated to be adequate, but he realized now that he needed 5 additional dogs to complete his work. Because Great Eastern's policy allowed an increase in the number of animals of up to 10% to be considered a “minor amendment” to a protocol, Marchetti requested the five additional dogs using the school's minor amendment form. Unfortunately, he received a quick call from the Great Eastern IACUC office informing him that the school's approved Assurance to the U.S. Public Health Service (PHS) only allowed researchers to add up to 10% more rats or mice as a minor amendment. Adding dogs, or any other species, in any number required a major amendment and a standard IACUC review of the request. Amazed and confused, Marchetti pleaded his case to the IACUC chairman, Dr. Larry Covelli. Covelli reminded Marchetti that the PHS considered an increase in the approximate number of animals used to be a significant change that required IACUC review. “But that's the problem,” said Marchetti, slowly losing his temper. “How can you and the PHS allow me to add 10% more mice as a minor amendment, but when I ask for the exact same percentage increase in dogs, it becomes a major amendment? What's the difference?”

“I'm sorry, Maurizio,” said Covelli. “But when we went to renew our PHS Assurance, we were told to clarify that the 10% addition limit was for rats and mice, not dogs. So we did that, and it was approved. I know it will take a little longer, but you'll have to submit this as a major amendment.”

What is your opinion? Should increases in animal numbers through minor amendments be limited to rats and mice, or should minor amendments also be used to add dogs and other large species?

Response to Protocol Review Scenario: Not a minor amendment

Response to Protocol Review Scenario: Addition is significant

Response to Protocol Review Scenario: No relevant difference