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Veterinary Verification and Consultation (VVC) (IACUC)

Last updated on December 14, 2021 8 min read Veterinary Verification and Consultation (VVC) (IACUC)

Purpose

The Office of Laboratory Animal Welfare (OLAW) published NOT-OD-14-126 “Guidance on Significant Changes to Animal Activities” on August 26, 2014. This policy allows for flexibility in the evaluation of certain proposed changes to animal protocols and outlines the specific significant changes that may be handled administratively 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 animal activity in this circumstance. This includes changes in:

  1. Anesthesia, analgesia, sedation, or experimental substances;
  2. Euthanasia to any method considered acceptable or acceptable with conditions (provided conditions are met) in the AVMA Guidelines for the Euthanasia of Animals
  3. Duration, frequency, type, or number of procedures performed on an animal.

In order to take advantage of this flexibility in whole or in part, the IACUC has established criteria that address significant changes eligible for VVC.

Covered Parties

This policy is applicable to all persons responsible for conducting research, teaching, training, breeding, and related activities, hereinafter referred to collectively as “activities”, involving vertebrate animals conducted at or under the auspices of Boston University.

University Policy

Changes to approved research projects must be conducted in accordance with the institution’s Assurance, the United States Department of Agriculture (USDA) Animal Welfare Act and Animal Welfare Regulations, and must be consistent with the Guide for the Care and Use of Laboratory Animals 8th edition unless an acceptable justification for a departure is approved. IACUC approval of proposed animal activities or significant changes to previously approved animal activities is granted after full committee review (FCR) or designated member review (DMR). The VVC process is used to apply specific conditions for the review and approval of significant changes that can be administratively approved by a veterinarian authorized by the IACUC (e.g., fall within policies, guidance documents, standard operating procedures, drug formularies that IACUC has approved). The veterinarian is not conducting DMR, but rather is serving as a subject matter expert to verify compliance with the IACUC-approved policy is appropriate for the animals in this circumstance. These policies and guidance documents must be reviewed and approved by the IACUC at intervals no less than once every three years. The veterinarians authorized to conduct VVC are those whose time is devoted to the animal care and use program.

Significant changes that require IACUC review include changes:

  1. From non-survival to survival surgery
  2. Resulting in greater pain, distress or degree of invasiveness
  3. In housing or use of animals in a location that is not overseen by the IACUCInstitutional Animal Care and Use Committee IACUC oversee...
  4. In species
  5. In study objectives
  6. In Principal Investigator (PI)
  7. That impact personnel safety

These changes must be reviewed by the IACUC via Designated Member Review (DMR) or Full Committee Review (FCR).

NOT-OD-14-126 Guidance on Significant Changes

Public Health Service Policy on Humane Care and Use of Laboratory Animals

Animal Welfare Act and Animal Welfare Regulations

Guide for the Care and Use of Laboratory Animals:  Eighth Edition

Review and Approval of Materials Submitted to the IACUC

Modification RequestsFCR/DMRVVCAdmin
Change from non-survival surgery to survival surgeryX
Change resulting in greater pain, distress, or degree of invasivenessX
Change in housing or use of animals in location that is not part of the program overseen by the IACUCX
Change in speciesX
Change in study objectivesX
Change in PIPrincipal Investigator View Boston University's policy on...X
Change that impacts personnel safetyX
Addition of a new procedure to the protocolX
Increase in animal numbers for protocol involving USDA-regulated speciesX
Increase in animal numbers >10% of original approved number for protocol involving species not regulated by USDAUnited States Department of AgricultureX
Addition of strain that may have an adverse phenotypeX
Change in anesthetic or analgesic regimen that falls within Anesthesia and Analgesia Recommendations or Anesthesia and Analgesia:  Neonatal Mice and RatsX
Change in euthanasia method to a method approved in the current AVMA guidelines for euthanasia. Method is acceptable or acceptable with conditions provided conditions are met.X
Change in frequency or volume of blood sample collection in protocol not exceeding approved limits according to ASC Blood Collection GuidelinesX
Change in rodent genotyping method to another approved method  in Collection of Tissues for Genotyping policy provided the method does not result in increased pain/distress/invasivenessX
Change to pharmaceutical grade drug of the same class (e.g., NSAID, antibiotic, etc.) provided conditions in IACUC policy Use of Pharmaceutical Grade and Non-pharmaceutical Grade Substances in Vertebrate Animals are metX
Change in dosing method or site according to ASC SOP Administration of Drugs and Experimental Compounds in Mice and RatsX
Increase in animal numbers up to 10% of original approved number for protocol not regulated by USDA 

X

Addition of strains with no adverse phenotype for species not regulated by USDAX
Minor change of standard diet or treat consistent with original protocol goals and from a commercially approved vendor to one of the following diets:X
Change to personnel other than the PI provided personnel are qualified, adequately trained, and meet other criteria as required by the IACUCX
Change in funding

X

 

Addition of animal housing or procedure rooms, provided such rooms are approved by the IACUC and the facility manager concurs with the use of the space for the purposes of the protocolX
Removal of animal usage location approved in protocolsX
Correction of grammar or typographical errorsX
Update contact informationX
 Change title of approved protocolX

History

Effective Date: 12/14/2021
Next Review Date: 12/13/2024

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