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.

1. 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.

2. 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 4^th 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.

3. 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.

4. 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.

Jerry Silverman 博士了解到，新的 VVC 流程应该会导致他的方案修正案迅速获得批准。因此，Jerry 请求他的兽医 Bernie Rollin 博士通过 VVC 流程授权他对方案进行修改。Rollin博士认为，除了动物数量增加少于10%的请求外，其他修改请求不符合VVC流程，必须使用DMR或FCR流程进行审查。

1. 1.

   添加新创建的Peromyscus基因株属于美国农业部动物定义的范围¹，并根据 GEU 的另一项协议获得批准；但由于这是西尔弗曼博士实验室的新菌株，他必须在方案的不良后果部分提供更多信息。皮炎需要额外的监测和潜在的兽医监督，因为与皮炎相关的疼痛和痛苦可能会增加。IACUC 审查将提供必要的保证，以便在必要时对动物进行监测和治疗，并且如果出现其他不良后果，兽医将了解情况²。

2. 2.

   西尔弗曼博士希望使用轨道后采血法。根据 GEU 的 IACUC 采血政策，眼眶后采血需要麻醉。尽管这在 Jerry 的其他协议中得到了批准，但他必须在该协议上确认该策略将通过对此方法使用必要的麻醉来遵循³。如果 Jerry 提供了不使用麻醉的科学依据，他还必须提供经过培训的工作人员使用眼眶后出血的熟练程度的确认⁴。这将确保动物不会承受看似痛苦的采血技术所造成的额外疼痛和困扰。除了这项新技术之外，杰里还希望添加第四^次收集活动。必须澄清以确保 14 天内总血量不超过动物体重的 1%。如果是这样，则可能需要液体治疗。需要进行此澄清，因为新的细节之前尚未获得批准。

3. 3.

   所描述的安乐死方法已获得 2020 年 AVMA 安乐死小组⁵的条件批准。要在没有麻醉的情况下增加颈椎脱位，这会导致额外的疼痛⁶，杰里必须描述为什么它在科学上是必要的³。另外，如果这种方法不能使用麻醉，那么 Jerry 必须确认经过培训的人员的熟练程度⁴。

4. 4.

   重要的是要记住，VVC 过程中不能添加任何会导致动物疼痛和痛苦增加的修正。通过 PHS 机构资助的所有工作，PHS 政策 IV.C.1.“PHS 进行或支持的研究项目的审查”要求审查 IACUC 批准的方案的所有新修改。“……IACUC 应确认该研究项目将根据适用于该研究项目的《动物福利法》进行，并且该研究项目符合该指南，除非提出了可接受的偏离理由。此外，IACUC 应确定研究项目符合机构的保证”，并通过提供适当的镇静、镇痛或麻醉，确保动物程序避免或尽量减少不适、痛苦和疼痛（符合合理的研究设计）⁷，除非具有科学依据³并且安乐死方法与 AVMA 安乐死专家组一致⁵。提供额外的培训机会以帮助研究界了解如何正确使用 VVC 流程将符合 GEU 员工的最佳利益。