University Standard
Title
University of North Carolina at Chapel Hill Standard on >Veterinary Verification and Consultation (VVC)
Introduction
Purpose
The standard described below provides guidance to Institutional Animal Care and Use Committee (IACUC) members and UNC researchers/investigators on changes and amendments to UNC approved IACUC protocols. Investigators may wish to make changes to approved applications during the three-year protocol approval time. These changes are handled in a variety of ways and depend on the type of change being requested, including administratively according to IACUC-reviewed and -approved policies in consultation with an authorized veterinarian as outlined in the Standard for Amendments and Other Protocol Changes.
Scope
All personnel, including animal handlers and Principal Investigators (PI) involved in the writing, revising, and amending of IACUC protocols. The standards described in this document apply to changes and amendments to all IACUC approved protocols.
The UNC-Chapel Hill IACUC expects that all individuals involved in animal work at the University will comply with this Standard. Requests for exceptions to this Standard must be reviewed and approved by the IACUC.
Standard
The following is a list of the significant changes to a protocol that have been described in IACUC-approved policies and CAN be reviewed by a designated veterinarian serving as an expert, and provided there is no increase in pain and distress, and that all changes are outlined in approved, pre-existing, IACUC-approved policy, standard, guidance document, or formulary:
- Laboratory location or surgical suite (non-USDA regulated species only)
- Rodent strain and sex (providing there are no significant health phenotypes)
- Tissues Harvested
- Utilizing a UNC Core to perform the work described in protocol
- Blood draw frequency, method, and/or volume
- Change to approved anesthetics, including the addition of a reversal agent
- Change to approved analgesics, including the addition of preemptive analgesia
- Change to approved methods of euthanasia
- IACUC approved changes in rodent tumor size (below 2.0 cm for mice, 4.0 cm for rats)
- Route of drug administration (IM, SC, IP, IV, IC), location of administration, and volume
- Drug dose (doses must be below those known to produce toxicity)
- Identification procedures (tattoo, ear tag, toe clip, microchip, ear punch)
- Genotyping procedures
- Breeding strategy (single adult after mating, two adults, trio)
- Changes to rationale for changes to social housing (non-USDA covered species only)
- Body weight loss (not to exceed 20%)
- Adjuvant (not including the addition of Complete Freund’s)
- Addition of Body Conditioning Score (BCS) to assess an animal's health status
- Post-operative/procedural care
- Changes to supportive care during anesthetized procedures
- Changes to surgical site preparation, such as hair removal methods and skin antiseptics; change of wound closure method
- Increases to monitoring frequency or the addition of new clinical signs, humane endpoints, and/or monitoring parameters (e.g., weight loss, BCS) while retaining those already approved (rodents only)
- Increases or enhancements to type of environmental enrichment
- A change to, or addition of, fasting when using oral gavage at the approved volume
- Substitutions to approved neuromuscular blocking agents (NMB); does not include additions or subtractions
Definitions
- IACUC: Institutional Animal Care and Use Committee
- DCM: Division of Comparative Medicine
- OACU: Office of Animal Care and Use
- University Standard: The minimum acceptable limits or rules used to achieve Policy implementation, enforceable by the IACUC.
- IACUC Protocol: The animal use application which describes research activities in detail and is reviewed and approved by the IACUC.
- Amendment: Changes to the IACUC protocol which require IACUC review prior to implementation.
- USDA: United States Department of Agriculture
- Non-USDA Regulated Species: Not governed under the Animal Welfare Act (AWA); includes mice (genus Mus), rats (genus Rattus), fish, reptiles, amphibians, and birds specifically bred for research
Related Requirements
External Regulations
University Policies, Standards, and Procedures
Contact Information
Primary Contact
- Name: Michael Chi
- Title: Associate Director, Office of Animal Care and Use
- Email: mchi@unc.edu
Other Contacts
Office of Animal Care and Use
Animal Health and Husbandry (DCM)