Response to Protocol Review Scenario: Reasonable and right

Given the information presented in the scenario, the initial responses of Great Eastern University's IACUC and veterinarian were completely in accordance with the concept of self-regulation that forms the basis of the PHS Policy on Humane Care and Use of Laboratory Animals¹ and the original intent of the Animal Welfare Act². I also agree with the stated position of the IACUC, that the noncompliance “was not serious enough to inform NIH/OLAW of the incident and its resolution.” Further, the fact that the IACUC's discussion of the incident was well-documented in the Committee's minutes is evidence that the University was not attempting to hide the incident.

In responding specifically to the two questions posed at the end of the scenario, I make three assumptions about facts not presented in the scenario: (i) the two investigators involved were both in good standing with the IACUC, (ii) the University had not been previously cited for investigator training deficiencies (iii) and the USDA inspector had not discovered other alleged noncompliance aspects of the institution's training program on this site visit. Given these assumptions, I believe that Covelli had not only a “reasonable” complaint, but a fully justified one! The inspector's unreasonable, overzealous decision to cite the University for “inadequate training of research personnel and for not having an appropriate proposal to conduct an animal activity” indicates a serious lack of professional judgment, probably fostered by APHIS' preposterous emphasis on 'gotcha' inspections, with inspectors being evaluated on the basis of how many citations they issue. Rather then being cited, Great Eastern should have been complimented (at least orally by the inspector, if not in writing on the inspection report)!

Secondly, I believe this kind of overzealousness on the part of any regulatory inspector serves to stifle open and full discussion about any regulatory issues, if the discussion is going to be recorded in official minutes available to regulatory inspections. It is only reasonable to expect humans to avoid potential negative repercussions from any such open discussion.

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