Development of Protocols

The PI and research staff develop the scientific concept that underlies an animal protocol. The PI is the expert in the scientific goals and the experimental design and is often highly knowledgeable about animal use and well-being. The veterinarian is the trained expert in the latter subject and can advise the PI and the IACUC on performance-standard development and implementation. However, the IACUC has the final responsibility and authority for evaluating the protocol outcome and approving exceptions to guidelines and regulations if any are necessary. The veterinarian should be involved in animal-use protocol development, preferably before the protocol is submitted to the committee for official review. Indeed, according to the AWRs, the veterinarian must be consulted for any procedure that may cause more than momentary or slight pain or distress (AWR 2.31(d)(1)(iv)(B)). In some cases, veterinary input is gathered primarily during the final protocol-review process, and this delay can complicate protocol review and prolong the approval process.

The IACUC staff and/or chair can solicit additional information and perform a prereview of the animal-use protocol to help the PI recognize portions of the protocol that require clarification or additional information. The IACUC must consider sample size, pain and/or distress, and experimental and humane endpoints among other considerations. The IACUC may request direct observation of a procedure (particularly a new or unusual procedure), pilot studies, and particular experimental measurements or monitoring procedure to evaluate and ensure animal well-being.

Execution of Protocols

The research team has the primary responsibility for animal assessment and intervention. However, researchers and the animal-care staff must coordinate their efforts to provide appropriate animal care and monitoring. Unanticipated adverse effects of the research that are or may be a threat to the health or safety of the animal must be reported to the IACUC immediately. As an animal-use protocol must describe any anticipated adverse effects, if an unanticipated adverse effect that was or could be a threat to the health or safety of the animal were to occur, then the protocol does not accurately reflect the animal-use activity and must be modified accordingly and reapproved.

The veterinary staff has the legal responsibility for animal care. Veterinary medical care is best administered with consideration for the scientific goals of the study. However, the veterinarian must have institutional authority to make decisions on behalf of the animal in critical situations.

The husbandry staff has day-to-day responsibility for assessment of animal well-being, regardless of experimental use. The caretaker staff is in a unique position to observe large numbers of animals and to understand the



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