Dr. Angel Gomez, a noted virologist, was developing a vaccine against the new H2N3 subtype of swine influenza virus. Because the virus can also infect ferrets, Gomez intended to use both pigs and ferrets in his research. He planned to have one group of each species immunized against the virus with another group serving as nonimmunized controls. Both immunized and nonimmunized animals would be challenged with the virus, with the expectation that only the nonimmunized ones would develop clinical signs of the disease.

On his IACUC protocol form, Gomez indicated that he would use a sufficiently high titer of virus to induce clinical disease, but based on field cases of flu in pigs, he believed that severe clinical disease would be exhibited in only the nonimmunized ferrets. He proposed letting the disease run its course, which could lead to death of some ferrets. The IACUC questioned the logic of this strategy, asking why the death of the ferrets was a needed endpoint, since most pigs recover from influenza virus infections in a few days. Gomez agreed that the disease was likely to be much less severe in pigs, but he needed to use the very sensitive ferrets to test the true efficacy of the vaccine. He said that death, if it were to occur, was a needed endpoint, particularly for the nonimmunized animals, because it was necessary to know whether any of those animals might spontaneously recover from the induced disease.

After deliberating on the protocol, the IACUC said that it would approve the study if Gomez modified it to allow the veterinary staff to treat any ferret health problems that were secondary to the flu virus, such as nasal congestion or bacterial infection. The intent was to make the animals somewhat more comfortable without interfering with the study's goals. However, Gomez balked at the request, saying that any form of treatment might interfere with the animals' immune response, which needed to be evaluated as part of his research. When questioned about what interference or other effects these proposed treatments might cause, he responded that he could not predict such effects and therefore it was necessary to leave the ferrets untreated.

Do you agree with Gomez or with the IACUC about the treatment of clinically ill ferrets? Is death a necessary endpoint for Gomez's research?

Response to Protocol Review Scenario: Try a pilot study

Response to Protocol Review Scenario: Consider non-medical treatments

Response to Protocol Review Scenario: Why use ferrets?