Response to Protocol Review Scenario: Needs IACUC oversight

All animal research, including clinical studies that involve the general public, must meet current regulatory requirements and oversight. Appropriate oversight protects the privilege of carrying out important research while ensuring an adequate standard of care.

The CAT scan is diagnostic of dogs suspected of having a stroke and, therefore, has clinical benefits for the animals enrolled. In contrast, the fMRI appears to have no immediate benefit or diagnostic purpose for the animals involved and includes the added risk of anesthesia. Therefore, the fMRI should be considered a form of research and not a routine diagnostic procedure. We feel that an IACUC should have oversight of this work. This will ensure that both institutions involved are in compliance with current legislation (dogs are included in the Animal Welfare Act¹ (AWA) and Regulations² (AWRs)) and will protect the animals involved by assuring appropriate third party risk assessment.

The AWRs (section [2.30(a)]) define a research facility to include “any school (except an elementary or secondary school), institution, organization, or person that uses or intends to use live animals in research, tests, or experiments, and that (1) purchases or transports live animals in commerce, or (2) receives funds under a grant, award, loan, or contract from a department, agency, or instrumentality of the United States for the purpose of carrying out research, tests, or experiments.” This definition would include Great Eastern. Eagle is enrolling the animals at Great Eastern, and his funding is awarded through Great Eastern. These facts require that Great Eastern be registered with the USDA and subject to IACUC review. We feel the privately owned dogs being used in Eagle's study are participating as subjects of basic research and are thus covered by the AWA.

If this is a singular situation of ongoing research at Southedge Hospital, we feel the most practical way to provide oversight would be for the Great Eastern IACUC to recognize Southedge as a satellite institution. Great Eastern would then place the hospital within their Animal Program and carry out the necessary programmatic review and site inspection tasks (AWRs section 2.31).

If other animal research projects are underway at the Southedge Hospital site, however, it would make the most sense for Southedge to become an independent entity and have its own Committee and registration with the USDA as having their own Animal Program. The Animal Program should include designating an Institutional Official, who would then appoint a full Committee in keeping with the requirements of the AWRs or in accordance with Public Health Service Policy³ (if any work is funded by the Public Health Service) and adopt a program of Veterinary Care.

Eagle will benefit from being in compliance, as there would be no space for doubt about the validity of his findings. We do wonder about the ethical ramifications of using a free CAT scan to encourage enrollment into this work, as this is an expensive procedure that owners may view as essential and thus feel pressured to accept the fMRI scans and requisite anesthesia without fully appreciating the risks. Informed consent is very important in enrolling any patient into a clinical trial, including this case.

We conclude that new animal enrollment or periodic scanning of enrolled animals in this work should cease until appropriate action is taken to assure these dogs are included in an Animal Program and covered by an animal use protocol evaluated by the appropriate Committee (at either Great Eastern or Southedge Hospital). In addition, Eagle should be made aware of the impact of his public statements to minimize any misunderstanding of the nature of his research in the future.

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