The issue at hand pertains to the selection between using VVC, DMR, or FCR for the review and approval of Dr. Silverman’s amendment. VVC is suitable for making significant changes to animal activities that are part of a previously approved protocol. The VVC process may not be used to add new procedures to a previously approved protocol1. All Dr. Silverman’s additional procedures will bring greater pain, distress or degree of invasiveness for the animals. Per PHS Policy IV.C.2., significant changes that result in greater pain, distress or degree of invasiveness must be approved by one of the valid IACUC methods, FCR or DMR2. Therefore, both the retro-orbital blood collection and cervical dislocation without anesthesia fall under this category. Dr. Silverman also intends to introduce a new mouse strain, but it’s important to note that deer-mouse strains are subject to USDA-regulations3. The question arises: does the USDA recognize VVC as an appropriate method? If so, could it be used in this case? To add, cervical dislocation without anesthesia is not permitted by the USDA without using FCR. It may be wise to consult the APHIS Veterinary Medical Officer (VMO) for GEU in this matter. One could argue that these same procedures were previously approved in another protocol; and if the amended procedures align with the principles of the 3Rs, then VVC could be used, or at the very least, DMR. I stand with Dr. Rollin’s decision to bring this amendment to FCR review, as there are far more questions than answers. It is better to proceed with caution than to risk non-compliance.
It appears that this scenario presents a good opportunity for GEU to revisit their VVC policy or guidelines. GEU should establish an inclusive IACUC-approved policy and/or guidance document that clearly outlines when the VVC process is appropriate. This would not only minimize confusion but also decrease regulatory and administrative burdens on both the IACUC and the Principal Investigator (PI), ultimately decreasing the lengthy review and approval process. To boot, it would help to avoid human pain and distress in the future…particularly, Jerry’s!
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