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Unexpected Death of Animal Subjects
Your experiment on dogs involves surgically implanting a drug delivery device, monitoring the dogs for a time, and then removing the device and monitoring for a while longer. Early on, some dogs unexpectedly die. It is not clear whether this resulted from the surgical procedure or the drug. Should you stop the experiments and refine the surgical procedure without administering any of the drug, even though this might ultimately sacrifice more animals? Or should you continue the experiment in hope that results might improve as the surgical procedure becomes more practiced, but with no guarantee of this? Or should you revisit the entire protocol design? K3R says: Since it has not been established whether the problem is the drug or the drug delivery device, it would be appropriate to halt drug administration and see if any other animals die from the delivery system alone. This would establish whether the surgical procedure and/or delivery device was responsible. Once this is established, the drug could be given again to see if it was inducing death. If mortalities recurred, the experiment should be halted as a non-tolerated drug dose is achieved.
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