Dr. Jerry Silverman learned that the new VVC process should result in his protocol amendments being quickly approved. Consequently, Jerry asked his veterinarian, Dr. Bernie Rollin to authorize his protocol modifications through the VVC process. Except for the request to increase the animal numbers by less than 10%, Dr. Rollin felt that the other modification requests did not qualify for the VVC process and had to be reviewed using either the DMR or FCR process.
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1.
The addition of the newly created genetic strain of Peromyscus, which is under the purview of the USDA’s definition of an animal1, is approved under another protocol at GEU; but since this is a new strain for Dr. Silverman’s lab, he must provide additional information within the adverse consequences section of the protocol. Dermatitis requires additional monitoring and potential veterinary oversight because of the potential increase in pain and distress associated with the dermatitis. The IACUC review will provide the necessary assurance that the animals will be monitored and treated, if necessary, and veterinarians will be made aware in the event other adverse consequences are present2.
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2.
Dr. Silverman wishes to use the retro-orbital method of blood collection. According to GEU’s IACUC Policy for Blood Collection, retro-orbital blood collection requires anesthesia. Although this is approved on Jerry’s other protocol, he must confirm on this protocol that the Policy will be followed by using necessary anesthesia for this method3. If Jerry provides scientific justification for not using anesthesia, he must also provide confirmation of proficiency of trained staff using retro-orbital bleeding4. This will ensure that animals will not endure additional pain and distress created by what appears to be a painful blood collection technique. Along with this new technique, Jerry wishes to add a 4th collection event. Clarification must be provided to ensure that the total blood volume does not exceed 1% of the animal’s body weight in 14 days. If it does, then fluid therapy may be necessary. This clarification is required because the new details were not previously approved.
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3.
The method of euthanasia, described, is approved with conditions in the 2020 AVMA Panel on Euthanasia5. To add cervical dislocation without anesthesia, which can cause additional pain6, Jerry must describe why it is scientifically necessary3. Also, if anesthesia cannot be use for this method, then Jerry must confirm proficiency of trained staff4.
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4.
It is important to remember that no amendment that results in an increase of animal pain and distress can be added by the VVC process. All work funded through PHS Agencies, the PHS Policy IV.C.1., “Review of PHS-Conducted or Supported Research Projects” requires review of all new modifications to approved protocols by the IACUC. “…the IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the research project conforms with the Institution’s Assurance” and ensures that procedures with animals avoid or minimize discomfort, distress, and pain (consistent with sound research design)7, by providing appropriate sedation, analgesia, or anesthesia unless scientifically justified3 and that euthanasia methods are consistent with the AVMA Panel on Euthanasia5. It would be in the best interest of the GEU staff to provide additional training opportunities to help the research community understand how to use the VVC process appropriately.
The addition of the newly created genetic strain of Peromyscus, which is under the purview of the USDA’s definition of an animal1, is approved under another protocol at GEU; but since this is a new strain for Dr. Silverman’s lab, he must provide additional information within the adverse consequences section of the protocol. Dermatitis requires additional monitoring and potential veterinary oversight because of the potential increase in pain and distress associated with the dermatitis. The IACUC review will provide the necessary assurance that the animals will be monitored and treated, if necessary, and veterinarians will be made aware in the event other adverse consequences are present2.
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