Veterinary Verification and Consultation (VVC)

Summary

Rationale/Purpose of the Policy: To allow for certain significant changes to be preapproved by the Institutional Animal Care and Use Committee (IACUC) and verified by a research veterinarian. This policy will facilitate and speed protocol revisions, improve compliance, and reduce the regulatory burden on principal investigators (PIs).

Full Description

Policy

In August 2014, the Office of Laboratory Animal Welfare (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.

The Attending Veterinarian (AV) (or the designated “back-up” Veterinarian) (see website) may administratively verify changes through Veterinary Verification and Consultation. “Veterinarian” throughout this document will refer to the AV or their designee.

Significant changes/modifications are first presented to the entire IACUC to review. Members are given 2 weeks to review, provide comments, and/or request for the change to be moved to a full committee meeting.

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. For all IACUC protocols, it is required that the veterinarian reviews protocols prior to their approval. Any changes must be approved by both the chair and the veterinarian. Consultation with the veterinarian is documented within the compliance system, SPARCS. 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.

This includes changes in:

1. anesthesia, analgesia, sedation, or experimental substances;
   1. Changes to anesthesia, antibiotics, analgesia, sedation, pre-anesthetic (anti-cholinergic, tranquilizer, anxiolytic), anesthetic reversal agent or paralytic to referenced drugs and dosages for the given species listed. Examples of eligible changes include:
      1. A change in dosage, route, frequency, or duration.
      2. Switching from one analgesic, anesthetic, or sedative agent to another
   2. euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals; and
   3. duration, frequency, type, or number of procedures performed on an animal. The change cannot increase animal pain or distress.

The following significant changes may not be handled administratively by VVC and must undergo either DMR or FCR.

1. Change from non-survival to survival surgery;
2. Change resulting in greater pain, distress, or degree of invasiveness;
3. Change in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;
4. Change in species;
5. Change in study objectives, experiments, techniques, or procedures;
6. Change in principal investigator (PI);
7. Change that impact personnel safety
8. Addition of a new experimental drug or chemical that may increase expected adverse outcomes or hazards to personnel.)
9. Changes to add non-pharmaceutical grade (NPG) drugs or change from pharma grade to NPG.
10. Addition of new pharmaceutical substances not previously approved in the protocol.

The following changes can be approved via an “administrative amendment” and can be approved by the Research Compliance Analyst(s) for the IACUC.

1. Changes to personnel OTHER than PI
2. Change in typographical errors or grammar

Resources:

• AVMA Guidelines for the Euthanasia of Animals
• OLAW Significant Changes to Animal Activities NOT-OD-14-126
• 9 CFR Ch 1 (Animal Welfare Regulations) Subpart C sections 2.31(d) and 2.33(a)
• PHS Policy on Humane Care and Use of Laboratory Animals
• Guide for the Care and Use of Laboratory Animals, 8th edition
• American College of Laboratory Animal Medicine position statement on Adequate Veterinary Care
• USDA Inspection Guide, Ch. 7.1.7
• Veterinary Formularies:
  • Exotic Animal Formulary, 5^th edition (2018), James W. Carpenter
  • Plumb’s Veterinary Drug Handbook 9^th edition (2018), Donald C. Plumb
  • Formulary for Laboratory Animals, 3^rd edition (2005), Terrance Hawk, Steven Leary, Timothy Morris
  • ACLAM online e-formulary https://www.aclam.org/publications 2021 version
  • Anesthesia and Analgesia in Laboratory Animals, second edition, 2008, Richard E. Fish, Peggy J. Danneman, Marilyn Brown, and Alicia Z. Karas, eds