Veterinary Verification and Consultation (VVC) (IACUC)

Last updated on November 14, 2024 9 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:

Anesthesia, analgesia, sedation, or experimental substances;
Euthanasia to any method considered acceptable or acceptable with conditions (provided conditions are met) in the AVMA Guidelines for the Euthanasia of Animals
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:

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

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

Guidelines

Anesthesia, Analgesics and Sedatives: The assigned veterinarian may use his/her discretion to authorize changes to the dose, route, concentration, volume, and/or duration of any anesthetic, analgesic or sedative agents already approved on the protocol. Changes to other agents not previously approved on the existing protocol may also be authorized under this mechanism providing the agent under request is listed in the IACUC-approved formulary and the requested usage is within the approved dose range. In addition, protocol personnel must be adequately trained in the use of the new drug.

Experimental Substances: The addition or deletion of an experimental substance, adjustment in dose, alternate formulation, or less invasive route of administration may also be authorized under this mechanism, assuming all conditions of IACUC Policy Use of Pharmaceutical Grade and Non-Pharmaceutical Grade Substances in Vertebrate Animals are met. Note that the addition of a non-pharmaceutical grade drug or a change from a pharmaceutical grade to a non-pharmaceutical grade drug requires additional justification and will not be authorized under this mechanism. Other IACUC policies may apply, including Administration of Drugs and Experimental Compounds in Mice and Rats, Additives to Drinking Water for Rats and Mice, and Adjuvants.

Euthanasia: The authorized veterinarian may use his/her discretion to authorize the use of any currently acceptable method in the AVMA Guidelines for the Euthanasia of Animals including those that are acceptable with conditions providing that conditions are met. Note that protocol personnel must be adequately trained in the use of the requested procedure.

Duration, frequency, type, or number of procedures performed on an animal: The assigned veterinarian may use his/her discretion to authorize minor procedural changes providing in the judgment of the VVC veterinarian the change will not unduly impact animal welfare (i.e., lessens or involves equivalent pain, acute or chronic stress, distress or effects upon animal welfare) and is consistent with current standards of veterinary practice and specifically addressed in IACUC policy. New procedures cannot be added by VVC and require IACUC review.

Documentation

The following process must be followed in regard to conduct and subsequent documentation of the VVC process:

All amendment requests are submitted by the PI through the Huron Research Suite IACUC submission process. Note that in emergency situations where animal health or welfare would be negatively affected by delay, this submission requirement can be temporarily waived. In these cases, requests can be made to the AWP office directly. The office will act to expedite the request and then work with the PI to ensure its proper entry into the protocol after authorization has been granted.
The AWP Compliance Specialist assigned to the protocol will evaluate the request and determine if it is eligible for VVC.
A VVC-authorized Veterinarian will then be assigned to the protocol amendment in the software. If the request is deemed to be urgent, the AWP Compliance Specialist will contact the VVC-Veterinarian via email or phone call to alert them of the situation, so as to expedite the request.
If the VVC veterinarian verifies that the request can be authorized via VVC, the veterinarian confirms that the requested change falls within IACUC-approved policies, selects the IACUC-approved policies that were used in making the determination, and confirms that the change is appropriate for the animals. The amendment is returned to AWP in the software.
The AWP Compliance Specialist will process the request, and the system will notify the PI of the authorization. Changes authorized at this point can be instituted immediately. There is no delay between approval and ability to institute the change.
If the veterinarian feels that the request does not fit within the established policies and procedures for VVC, the veterinarian indicates when returning the VVC review in the software that the request should be reviewed by the IACUC. The amendment will then be processed by the IACUC office and reassigned for DMR or FCR as appropriate. The veterinarian may refer the request to IACUC for any reason.

Responsible Parties

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 Requests	FCR/DMR	VVC	Admin
Change from non-survival surgery to survival surgery	X
Change resulting in greater pain, distress, or degree of invasiveness	X
Change in housing or use of animals in location that is not part of the program overseen by the IACUC	X
Change in species	X
Change in study objectives	X
Change in PIPrincipal Investigator View Boston University's policy on...	X
Change that impacts personnel safety	X
Addition of a new procedure to the protocol	X
Increase in animal numbers for protocol involving USDA-regulated species	X
Increase in animal numbers >10% of original approved number for protocol involving species not regulated by USDAUnited States Department of Agriculture	X
Addition of strain that may have an adverse phenotype	X
Change in anesthetic or analgesic regimen that falls within Anesthesia and Analgesia Recommendations or Anesthesia and Analgesia: Neonatal Mice and Rats		X
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 IACUC policy Blood Collection Guidelines		X
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/invasiveness		X
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 met		X
Change in dosing method or site according to IACUC policy Administration of Drugs and Experimental Compounds in Mice and Rats		X
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 USDA		X
Minor change of standard diet or treat consistent with original protocol goals and from a commercially approved vendor to one of the following diets: Breeder diet Doxycycline diets: 45-625 mg/kg High fat or High Fat high sucrose Low Fat Diet		X
Change to personnel other than the PI provided personnel are qualified, adequately trained, and meet other criteria as required by the IACUC			X
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 protocol			X
Removal of animal usage location approved in protocols			X
Correction of grammar or typographical errors			X
Update contact information			X
Change title of approved protocol			X

History

Effective Date: 11/14/2024
Next Review Date: 11/13/2027

Veterinary Verification and Consultation (VVC) (IACUC)

Purpose

Covered Parties

University Policy

Guidelines

Documentation

Responsible Parties

History

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Veterinary Verification and Consultation (VVC) (IACUC)

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Purpose

Covered Parties

University Policy

Guidelines

Documentation

Responsible Parties

Related Policies and References

History

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