We believe that while there is no animal welfare issue to be addressed by including Mason's biomedical research on an IACUC protocol, it would be prudent from a regulatory standpoint to include it on one.

The Animal Welfare Regulations exclude farm animals used or intended for use for improving the quality of food or fiber1. We assume Ramos' work is not federally funded, so there is no regulatory requirement for this work to be included on an approved IACUC protocol through the PHS Policy on Humane Care and Use of Laboratory Animals2. Based on the response of the IACUC chair, we further assume that the program of animal care and use at Great Eastern University excludes the use of agricultural animals in the improvement of food or fiber. Therefore, there is no institutional requirement for this work to be on an approved IACUC protocol. Further thoughts on this latter assumption will be discussed later in the response.

If the samples for Mason's work were exclusively left over from the samples taken for Ramos' work, then additional IACUC approval would not be necessary under the above assumptions. However, because Mason may require a specific number of samples under controlled circumstances or may require additional samples beyond those left over from the agricultural work, having an IACUC approved protocol for his work would be prudent to ensure regulatory compliance for the biomedical research as it moves forward. In addition, some journals require a statement that described animal work was covered under an IACUC protocol. The IACUC should establish that only biomedical personnel taking samples for use in Mason's work (ie Mason and his staff) be included on an IACUC protocol. Under this condition, Ramos' work should not be affected, but she would need to allow Mason to obtain his own samples.

With respect to the institutional exclusion of Ramos' work from an IACUC protocol in the first place, we had two additional thoughts. First, we wondered whether Great Eastern University is AAALAC accredited or not. AAALAC follows the Guide for the Care and Use of Agricultural Animals in Research and Teaching (the Ag Guide) as one of its primary references. The Ag Guide states that an active IACUC is a critical component of an effective institutional program of agricultural animal care and use3. The IACUC Handbook states that “In order to preserve relations with the USDA and a good reputation and to obtain and maintain AAALAC accreditation, any institution doing agricultural research with food and fiber species should endorse the principles in the agricultural guide.”4 Second, if Ramos' work includes instruction of trainees or students, this teaching component might fall under the Animal Welfare Regulations. If Great Eastern is AAALAC accredited, or if Ramos' use of these animals includes teaching, then we would expect her work to be described in an IACUC protocol.

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