Chester Gipson

A word from OLAW and USDA.

It is my opinion that Eagle’s work as described with privately owned dogs is a clinical study that has been reviewed by and is being overseen by the Clinical Trials Committee of Great Eastern University’s veterinary school. Therefore, it would not fall under the auspices of Great Eastern’s IACUC. The dogs are privately owned and do not belong to either Eagle or Great Eastern. In addition, the owners have given informed consent, which should have included the possibility of anesthetic complications and fully described what is meant by ‘periodic’ fMRI studies. If the work was a clinical study that was designed for research purposes only, then an approved IACUC protocol and oversight would be necessary. The imaging and anesthesia would have to be fully described, and Southedge Hospital would need to be cited as a satellite location and inspected by the IACUC. T h e f r u s t r a t i on o f t h e s ch o o l ’s veterinarians is understandable, as Eagle’s attitude appears to be rather dismissive of their concerns. However, as a veterinary neurologist, Eagle is well within his rights to utilize the information gleaned from these diagnostic tests in his research.

A word from USDA and OLAW.

no immediate concern for the welfare of animals in Clark’s current research: the IACUC approved the protocol and any pain and distress is addressed and relieved. The veterinarian, IACUC and PI should work collaboratively and consider taking a few subsequent steps. Firstly, they can carry out one or more pilot studies and evaluate the experimental context of these techniques, such as time from surgery to experimental endpoint or next surgical procedure. Secondly, they can assess the quick, obvious resolution, or it can be more complicated and require upfront investment by the IACUC, as is the case with Clark. With changes of this magnitude, the IACUC should first address appropriateness and, here, the effect such changes could have on research that is funded by an institution like the NIH. Significant changes in methodology should not occur in the middle of a grant; instead, the suggested change should be thoroughly investigated and implemented at an appropriate time. This approach is especially appropriate in While everyone agrees that animal welfare is the most important priority, and while both perspectives are correct, the potential negative cost to the PI’s research and laboratory is daunting. The principles of the 3Rs, as reflected in the Guide for the Care and Use of Laboratory Animals, require that researchers and IACUCs consider the “availability or appropriateness of the use of less-invasive procedures” and “unnecessary duplication of experiments” when reviewing a protocol1. Addressing these principles can be a A word from USDA and OLAW

Breeding without research. A word from OLAW and USDA.

committee that all of Spencer’s “unforeseen” problems are resolved. Any future protocols the IACUC action. Future work on the animals (frogs) under this protocol should be resumed only after obtaining permission 2. Silverman, J., Suckow, M.A. & Murthy, S. The IACUC Handbook 2nd edn. 158 (CRC Press, boca Raton, FL, 2007). 3. Office of Laboratory Animal Welfare. Institutional Animal Care and Use Committee Guidebook 2nd edn. 97 (US Department of Health and Human Services, Washington, DC, 2002, reprinted 2008).

Response to protocol review scenario: A word from USDA.

appropriate. First, Great Eastern could argue that the animals at the WRO are excluded from the Animal Welfare Act. Section 9 CFR 1.1 defines an animal as “any live or dead, dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any warm blooded animal which is used for research, teaching, testing, experimentation, or exhibition purposes or as a pet”1. Because the animals at Happy Trails are not used for any of these purposes, they are not covered by the Animal Welfare Act. Second, although, 9 CFR 2.3 (a) states “each applicant must demonstrate that his or her premises and any animals, facilities, vehicles, equipment, or other premises used or intended for use in the business comply with the regulations and standards”1, Great Eastern University could argue that the building used by the WRO wasn’t part of Great Eastern’s research enterprise; the WRO animals are not the property of the university, and therefore the university is not responsible for them. Several actions should have been taken to delineate the relationship between the WRO and Great Eastern University. of Health and Human Services, Washington, DC, 2006; revised 2009). <http://grants.nih.gov/ grants/olaw/faqs.htm#IACUC_9>