On August 26, 2014, NIH released Notice NOT-OD-14-126, Guidance on Significant Changes to Animal Activities1, with the concurrence of USDA, APHIS, Animal Care. According to this Notice, specific significant changes may be handled administratively by Veterinary Verification and Consultation (VVC), as long as they are described in a pre-existing IACUC-reviewed and -approved policy. The IACUC should have an approved VVC policy that lists VVC-eligible significant changes accompanied by IACUC-approved policies/references for each that set allowable parameters for use by the IACUC-authorized veterinarian for verification. A veterinarian authorized by the IACUC may review and verify that the proposed significant changes are consistent with the policy. An institution may choose to further restrict the use of VVC, as is the case here with GEU. The IACUC-authorized veterinarian(s) handling significant change requests may refer any request to the IACUC for review for any reason and must refer any request that does not meet the parameters of the IACUC-reviewed and -approved policies for IACUC review by Designated Member Review (DMR) or Full Committee Review (FCR). A significant change “resulting in greater pain, distress, or degree of invasiveness1” does not qualify for VVC and must be reviewed by FCR or DMR. Also, the description of a procedure on one IACUC-approved protocol does not qualify it for inclusion on another protocol and cannot be used as an IACUC-approved reference for verification by the veterinarian by VVC. Each proposed significant change must be considered for the animals in the context of their specific protocol. Therefore, Dr. Rollin correctly referred the addition of a potentially adverse phenotype and the proposed use of retro-orbital blood collection (due to GEU’s policy) to the IACUC. The GEU IACUC requirement for review of scientific justification for the use of cervical dislocation without anesthesia also precludes review via administrative handling, such as VVC. The proposed increase in the number of rounds of glucose testing (via tail blood draw) may have qualified for VVC as a significant change in the “number of procedures performed on an animal1”, provided the procedure met the requirements of the IACUC-approved policies/references.
USDA concurs with OLAW’s Guidance on Significant Changes to Animal Activities, including the IACUC’s discretion to allow the administrative handling of some significant changes to approved animal activities following veterinary verification of IACUC-reviewed and -approved policies1. Furthermore, USDA emphasizes the veterinarian’s authority to refer any request to the IACUC for review for any reason and the requirement that the veterinarian refer any request that does not specifically meet the parameters of the IACUC-reviewed and -approved policies or that may result in greater pain, distress or degree of invasiveness. While the AVMA Guidelines on Euthanasia describe humane methods of euthanasia that are compliant with the AWR, the AWR themselves define the regulatory standard by which methods of euthanasia are evaluated for compliance2. In this case, Dr. Silverman’s request for significant changes to his previously approved activities does not specifically align with GEU’s IACUC-reviewed and -approved policies, adds procedures not previously approved on the protocol, and the additional procedures proposed will result in greater pain and distress. Thus, Dr. Rollin’s referral to the IACUC is warranted, and IACUC review and approval through one of the two methods described in the AWR (DMR or FCR) is required3.
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