Policy Title: Veterinary Verification and Consultation (VVC)
Purpose: Allows for certain significant changes to be preapproved by the IACUC and verified by a research veterinarian. This policy will facilitate and speed protocol revisions, improve compliance, and reduce the regulatory burden on UW PIs.
POLICY: In August, 2014 OLAW provided new guidance on Significant Changes to Animal Activities NOT-OD-14-126 in an effort to support the use of performance standards and professional judgment and to reduce regulatory burden.
At UW-Madison, the following significant changes to an IACUC protocol may be handled administratively without review by full committee or designated member review.
Only the UW Madison Chief Campus Veterinarian or delegates (see list) may administratively verify changes through Veterinary Verification and Consultation (VVC) if changes are consistent with policies (guidance documents, SOPs and formularies) previously approved by the IACUCs. These changes may include:
a) Anesthesia, analgesia, or sedation to referenced drugs and dosages for the species.
b) Experimental substances including a change in test compound, dose, or route of administration as long as the change does not result in a change in study objectives or greater pain, distress, or degree of invasiveness.
c) Euthanasia to any method approved in the current AVMA Guidelines for the Euthanasia of Animals.
d) Duration, frequency, type, or number of previously approved procedures performed on an animal as long as the change does not result in greater pain, distress, or degree of invasiveness. For some procedures, different variations of the procedure can be approved (i.e. blood draw type).
The significant changes described above, may be handled administratively according to IACUC-reviewed and -approved policies in consultation with a veterinarian authorized by the IACUC. The veterinarian is not conducting DMR, but is serving as a subject matter expert to verify that compliance with the IACUC-reviewed and -approved policy is appropriate for the animals in this circumstance.
Consultation with the veterinarian must occur before any change in work is started and must be documented. A list of changes administratively handled by VVC will be provided to the IACUC at least quarterly. The veterinarian 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. The following significant changes may not be handled administratively by VVC and must undergo either full committee or designated member review.
a) From non-survival to survival surgery
b) Resulting in greater pain, distress, or degree of invasiveness
c) In housing or use of animals in a location that is not part of the animal program overseen by an IACUC.
d) In study objectives
e) In Principal Investigator
f) That impact personnel safety
g) From euthanasia method approved in the AVMA Guidelines for Euthanasia to one that is not.
h) Addition of new procedure type
See companion SOP for specific examples and a list of guidance documents, SOPs, and formularies currently approved by the IACUCs for VVC
Author: G. Orner, J. Welter, H. McEntee
ePublication Date: 3/2016
History: Approved by SVM ACUC 2016 02 09, CALS ACUC 2016 02 18, LSVC ACUC 2016 02 19, and SMPH ACUC 2016 03 07.