Research Insights
Reduced Burden for Making Significant Changes to AUPs
In an effort to reduce regulatory burden for investigators, the NIH and USDA recently issued new guidance regarding the review process required for significant changes (Amendments) to approved Animal Use Protocols (AUP).
In an effort to reduce regulatory burden for investigators, the NIH and USDA recently issued new guidance regarding the review process required for significant changes (Amendments) to approved Animal Use Protocols (AUP). The use of IACUC-reviewed and approved policies may now be used for the administrative handling of many significant changes. Recognizing the value of performance standards and professional judgment, this new guidance allows the following types of Amendments to be implemented simply following consultation and verification by the Attending Veterinarian:
1.) changes in anesthesia, analgesia, sedation or experimental substances
2.) changes from one AVMA-approved method of euthanasia to another
3.) changes in duration, frequency, type or number of procedures performed on an animal (provided the change does not result in greater pain or distress, doesn’t change from a nonsurvival to a survival surgery or doesn’t impact study objective or the safety of personnel)
This new Veterinary Verification and Consultation (VVC) process will allow Amendment approval without typical IACUC-review regardless of the AUP category. The VCC process will result in a significant reduction in paperwork associated with study modifications and a faster turn-around time for approval. The decision on whether or not an Amendment meets the criteria for the VCC process is at the sole discretion of the Attending Veterinarian.
Furthermore, and with perhaps more impact on reducing burden, this new guidance also allows for the reference of approved IACUC policies on an AUP in lieu of detailed descriptions. Policies like the “Common Technical Procedures” on the IACUC website can now be referenced in an AUP without inclusion of a full procedure description. The IACUC is currently in the process of expanding its policies to include more reference materials that can be used in protocols. You can find a full listing of IACUC-approved policies on the website at https://research.uga.edu/oacu/iacuc
For additional information, please contact the Office of Animal Care and Use or the IACUC at iacuc@uga.edu You can also find out more from your Attending Veterinarian.