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Response to Protocol Review Scenario: Complex circumstances

Lab Animal volume 38, pages 77–78 (2009)Cite this article

At first glance, the issues facing the Great Eastern IACUC seem straightforward, but on closer inspection, they are even more complex than Covelli has presented to the IACUC. The arguments presented by Covelli regarding the separation of the two institutions appear to be valid reasons for the Great Eastern IACUC to decline review of the protocol. The Animal Welfare Act Regulations (9 CFR C.2.30(a) Registration Requirements and Procedures1) state that “(1) Except as provided in paragraph (a)(2) of this section, where a school or department of a university... intends to use live animals for research, tests, experiments, or teaching, the university... rather than the school or department will be considered the research facility and will be required to register with the Secretary.... (2) In any situation in which a school or department of a university... demonstrates to the Secretary that it is a separate legal entity and its operations and administration are independent of those of the university..., the school or department will be registered rather than the university... (3) A subsidiary of a business corporation, rather than the parent corporation, will be registered as a research facility unless the subsidiary is under [the] direct control of the parent corporation...”. The diagnostic laboratory, although it is a state-funded entity, is an agency of the state Department of Health and, as such, appears to have separate financial support from that provided to Great Eastern by the state. In addition, the diagnostic laboratory has separate administration from Great Eastern and appears to be separated from the university physically, as they do not share the physical space occupied by the diagnostic laboratory.

On the other hand, many state diagnostic laboratories provide training to university graduate and professional students as part of their formal educational coursework and function as university departments as well as parts of the state's Department of Public Health or Agriculture. If this is the case, then the laboratory would not be a separate entity but would be considered part of the university, and the Great Eastern IACUC would be responsible for the activities of the laboratory. There is no evidence that the State Rabies Diagnostic Laboratory in this case functions in this manner, but this is one of several issues that the IACUC should clarify before declining to review the protocol.

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References

  1. 9 CFR 2.30(a). Registration. Requirements and Procedures.

  2. Georgia Department of Human Resources, Division of Health. Georgia Rabies Control Manual 5th edn. (2007) <http://health.state.ga.us/pdfs/epi/zvbd/Rabies%20Manual%202007%20Final%20with%20Cover.pdf>.

  3. National Association of State Public Health Veterinarians, Inc. Compendium Animal Rabies Prevention and Control, 2007. MMWR Morb. Mortal. Wkly. Rep. 56 (RR-3), 1–12 (April 6, 2007).

  4. National Association of State Public Health Veterinarians, Inc. Compendium Animal Rabies Prevention and Control, 2008. MMWR Morb. Mortal. Wkly. Rep. 57 (RR-2), 1–12 (April 17, 2008).

  5. California Department of Health Services, Veterinary Public Health Section. California Compendium Of Rabies Control And Prevention, 2004. <http://www.cdph.ca.gov/HealthInfo/discond/Documents/Rabies/CA%20Compendium%20of%20Rabies%20Control%20and%20Prevention%202004.pdf>.

  6. American Veterinary Medical Association. Private Ownership of Wild Animals (2006) <http://www.avma.org/issues/policy/wild_animal_ownership.asp>.

  7. Council of State and Territorial Epidemiologists, Infectious Disease Committee. Translocation of Wildlife. Position Statement 1994-4. (1994) <http://www.cste.org/ps/1994/1994-04.htm>.

  8. National Animal Control Association. Extended Animal Control Concerns – Exotics (2004) <http://www.nacanet.org/polexotics.html>.

  9. National Association of State Public Health Veterinarians. Comments on “Proposed Revision of HHS/CDC Animal-Importation Regulations” (2007) <http://www.nasphv.org/Documents/CorrespondenceANPRM-Exotic.pdf>.

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  1. Blumenthal is Managing Consultant at Gracewood Associates, Charlotte, NC.,

    Susan R. Blumenthal

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Blumenthal, S. Response to Protocol Review Scenario: Complex circumstances. Lab Anim 38, 77–78 (2009). https://doi.org/10.1038/laban0309-77b

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