Efficient and clear communication is of particular importance when principal investigators, attending veterinarians (AVs) and IACUCs are determining humane intervention points and adequate monitoring procedures for animals participating in research protocols. Hodges' elaborate remote monitoring and drug-delivery mechanism was shown to be effective through validation at his previous institution. But an action plan for unexpected events that might occur during the monitoring period has not been adequately defined.

The AV would be the ideal person to develop this action plan in collaboration with Hodges. The Guide for the Care and Use of Laboratory Animals1 states, “The primary focus of the veterinarian is to oversee the well-being and clinical care of animals used in research, testing, teaching, and production. This responsibility extends to monitoring and promoting animal well-being at all times during animal use and during all phases of the animal's life.” In this situation, definition of humane intervention points will be critical. Once specific clinical risks are identified (e.g., high or low blood glucose concentrations, high or low heart rate, etc.), limits must be set to determine when euthanasia will be required. If Hodges plans to use remote monitoring systems, then he should be expected to return to the facility immediately to treat or euthanize any animals reaching these humane intervention points.

Hodges' “one-man operation” may not be appropriate for extended monitoring periods. The IACUC, the AV and Hodges should identify the adverse events that are most likely to be seen, the experimental time points at which they are likely to be seen and the level of pain or distress expected to result from these. This information may be available from previous studies, enabling Hodges to carry out a risk assessment to determine an appropriate monitoring interval that will allow early detection and prompt resolution of the majority of adverse events. If the information is unknown, then Hodges should carry out a pilot study to identify the most critical time period for animal monitoring, as well as the incidence and severity of adverse events. Once a plan has been approved by the IACUC, post-approval monitoring should be implemented in the early stages of study execution, and the observations of this monitoring should be used to determine whether adjustments should be made to the monitoring protocol to ensure that animals are not experiencing unnecessary pain or distress. This should be a collaborative effort between the IACUC, the AV and the investigator.

Although Hodges' monitoring device represents a refinement to one aspect of post-surgical monitoring, the IACUC's concerns surrounding humane intervention points are also valid. This scenario represents on opportunity for Hodges and the IACUC to work together to improve animal well-being and build trust within the Great Eastern University community. A collegial, cooperative and consultative approach is needed in this situation to exploit the benefits of Hodges' monitoring procedures and alleviate the concerns of the IACUC.

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