In this case, the IACUC and Attending Veterinarian had one idea about the meaning of 'standard of care' and 'performance standards' but the researcher had a very different idea. The first step taken by the IACUC should be to temporarily discontinue the use of the cisplatin, as it poses a potential hazard to the animal care staff and is not approved in the protocol. A hazardous chemical specialist should be consulted to advise Birnbaum, Brown and animal care staff on how to handle the current contaminated cages and exposed animals. An occupational health physician may also be consulted to help determine whether there have been any significant employee exposures. The animals should be examined to determine whether they are experiencing any adverse effects.

Birnbaum, in consultation with the campus safety professional, should then establish a procedure to safely work with cisplatin in the facility. Once this plan has been established, he should amend his animal care protocol to include cisplatin. Once all approvals have been granted, the work can resume.

We suggest two changes in protocol review procedures that may help to avoid these types of issues in the future.

First, the IACUC protocol form should be revised to state clearly that researchers must list all animal manipulations, and the form should include a section addressing potentially hazardous agents. The Guide for the Care and Use of Laboratory Animals indicates that animal care protocols should cover the use of hazardous materials and provisions for a safe working environment1. The IACUC should work closely with the safety committee or with an environmental health and safety specialist to ensure that work involving hazardous agents in animals is appropriately designed and reviewed so that the animal care and research staff are protected. If the institution does not have a safety committee, then the IACUC should provide the necessary review.

Second, when reviewing protocols, the IACUC should avoid approving vague statements, such as “animals will be cared for using standard care for tumors,” as these are of little use unless the IACUC has an approved standard operating procedure or policy for the care of animals with tumors. Birnbaum should have been asked to describe the care of animals with tumors in detail, including information such as dose, frequency and route of administration of any medications; routine monitoring; potential adverse effects; methods to minimize potential pain and distress; and humane endpoints.

In conclusion, it is important to have a well-designed protocol form that captures all of the needed information to ensure both animal and employee well-being. This, along with a thorough protocol review, will help to avoid the situation described above.

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