ARPO Policy - Veterinary Verification and Consultation (VVC)

1.0 - Scope

This policy applies to animal subjects research under the Indiana University Animal Care and Use Program.

2.0 - Policy Statement

This policy applies to changes made to a protocol and the approval process. The VVC 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.

Any changes to an already approved IACUC protocol must be approved by the IACUC prior to implementation. Any changes via the VVC process must also be approved prior to implementation. If a change is implemented prior to approval, it is considered protocol non-compliance. 

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3.0 - Procedures

The IU Bloomington and IU Indianapolis IACUCs have adopted the direction provided in the NIH Guide Notice NOT-OD-14-126 for review of proposed changes to a previously approved animal study.

Significant changes must be approved by one of the valid IACUC approval methods described in the PHS Policy IV.C.2., that is FCR or DMR. These review processes are described in IU’s IACUC SOP.

The specific significant changes described below however, may be handled administratively according to IACUC-reviewed and -approved policies in consultation with a veterinarian authorized by the IACUC. 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 is serving as a subject matter expert to verify that compliance with the IACUC-reviewed and IACUC-approved policy is appropriate for the animals in this circumstance. Consultation with the veterinarian must be documented. 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 veterinarians authorized to conduct VVC are those whose time is devoted to the IU Bloomington or IU Indianapolis animal care and use program.

The Attending Veterinarian or his/her authorized veterinarian delegates may administratively verify changes through veterinary verification and consultation (VVC) if changes are consistent with policies (guidance documents, standard operating procedures, and formularies) previously approved by the IU IACUCs. For the purposes of this policy, IACUC approved formularies are outlined as below, with dosages chosen based on the experience and judgment of the veterinarian.

These significant changes may include:

• Anesthesia, analgesia, or sedation to referenced drugs and dosages for the species as long as anesthesia, analgesia, or sedation are already approved in the protocol. The VVC process cannot add anesthesia, analgesia, or sedation to a study.
• 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 addition of a new procedure or greater pain, distress, or degree of invasiveness.
• Euthanasia to any method that is approved in the current American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals.
• Duration, frequency, type, or number of previously approved procedures performed on an animal (e.g., addition of one blood-draw) as long as the change does not result in greater pain, distress, or degree of invasiveness or change the study objectives or is an addition of a new procedure.

The following significant changes may not be handled administratively by VVC and must undergo either a full committee or designated member review. 

• Any change from non-survival to survival surgery.
• Addition of a non-survival procedure.
• Addition of a survival surgery.
• Addition of a test compound.
• Addition of a training cohort of animals.
• Anything the results in greater pain, distress, or degree of invasiveness.
• Change in housing or use of animals in a location that is not part of the animal program overseen by an IACUC.
• Change in housing to a location that has not been inspected and approved by the IACUC.
• Change in study objectives.
• Change in principal investigator.
• Change(s) that impact personnel safety.
• Change from the euthanasia method approved in the AVMA guidelines for euthanasia to one that is not.
• Addition of a new procedure.
• Addition of species.
• Other changes that many not qualify as VVC.

4.0 - Sanctions

Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with animal subjects, up to and including suspension or debarment from engaging in research with animal subjects at Indiana University.

5.0 - History

This policy was revised to reflect that this Policy applies to all animal research at both Indiana University - Indianapolis, and Indiana University - Bloomington campuses.