In response to the questions posed in this scenario, the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) and the Office of Laboratory Animal Welfare (OLAW) offer the following guidance:

This scenario involves a study in which human surgical patients are allowed post-operative visits with their pets. Blood samples are collected from the patients before and after the visits to evaluate whether interactions with their pets reduce cortisol levels. This activity is not regulated by the Animal Welfare Act (AWA) because the pets are not the subjects and are not undergoing any manipulation for research or experimentation. Under §2143(a)(3)(A) of the AWA, the research facility is required to ensure that pain and distress are minimized during animal care, treatment and practices in experimental procedures1. Pets spending time with their owners is not an experimental procedure; therefore, regulating this type of activity was not the intent of the AWA, and the activity does not require IACUC approval. It is, however, recommended that the IACUC be kept apprised of all activities involving animals to ascertain whether they are under the purview of the AWA.

The Public Health Service (PHS) requires that the standards of the PHS Policy on Humane Care and Use of Laboratory Animals (Policy) be applied to research, testing and training funded by the PHS2. Although the animal activity described in the scenario is privately funded, it is being conducted as a part of a human-subjects study within the institutional research program, which presumably does receive PHS funds. Oversight of such activities by the IACUC ensures a uniform and consistent standard within the program and facilitates quality research3. If medical students are being trained through observation of an animal activity, IACUC oversight is also necessary.

Additionally, IACUC oversight may not only ensure animal and human safety but also limit liability to the institution should a patient's pet be injured accidentally or cause harm to other patients, visitors or staff members. Use of a consent agreement developed with legal counsel is a prudent practice4. The agreement should include an explanation of the purpose and the procedures involved in the study, the potential benefits and risks to the animals and the responsibilities and rights of the owner and the institution5.

In this scenario, the faculty member is affiliated with both the hospital and the university. Such dual appointments are quite common at many medical research facilities. If the hospital does not have its own IACUC, then the university's IACUC would be the default oversight body and a formal written understanding between the institutions should be in place6,7.

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