Review and Approval of Protocol Amendments and Use of Veterinary Verification and Consultation (VVC)

Policy

The IACUC-approved protocol must accurately reflect the animal activities occurring. If changes to procedures, monitoring parameters, timelines, animal numbers, personnel, or any other aspect of the protocol are needed, an amendment must be submitted. This amendment must be reviewed and approved before changes in practice are implemented. In some cases, the Attending Veterinarian (or designee) may direct modifications to procedures that are necessary to alleviate pain or suffering of individual animals (e.g., modified anesthetic or analgesic administration) due to unexpected adverse effects while an amendment to reflect those changes is underway.

There are three categories of IACUC protocol amendments, each involving different procedures for review and approval.

Each amendment or change will be assessed on a case-by-case basis, using the criteria below, to determine the appropriate category for review and approval. Protocol changes that meet a specific set of criteria may qualify for processing through VVC, rather than by standard IACUC review (DMR or FCR). These changes must fall within policies, guidance documents, standard operating procedures, and/or drug formularies that the IACUC has approved and must not increase the potential for pain or distress.

Office of Animal Welfare (OAW) staff or veterinarians may request IACUC review of proposed amendments at any time.

Section A: Changes that Require IACUC Review by FCR/DMR

An amendment that meets the regulatory definition of a significant change and that must be reviewed and approved using the standard approval methods described in the PHS Policy IV.C.2. (FCR or DMR) includes any proposed modification of an IACUC-approved protocol that results in any of the following:

1. Changes in surgical procedures:

a. from not involving surgery to involving surgery

b. from non-survival to survival surgery

c. from minor surgery to major surgery

d. from a single surgical procedure to multiple surgical procedures

2. Changes resulting in greater pain, distress, or degree of invasiveness from what was either specified or presumed to occur when the protocol was originally reviewed

3. Changes in euthanasia to a method not approved by the American Veterinary Medical Association (AVMA)

4. Changes in housing and/or use of animals in a location that is not part of the animal program overseen by the IACUC

5. Changes in species

6. Changes in study objectives or overall aims

7. Changes in PI

8. Changes in animal numbers that do not meet criteria specified in Section C below

9. Changes that impact personnel safety

Section B: Changes that Meet Guidelines for Use of VVC

Some amendments that meet the regulatory definition of a significant change may be processed administratively by use of VVC. These amendments must be consistent with institutionally-developed and IACUC-approved policies (e.g., guidance documents, standard operating procedures, drug formularies). VVC determination may be performed by the Attending Veterinarian (AV) or any veterinary designee of the AV. VVC veterinarians must be trained in the VVC process and must be familiar with IACUC policies. In these cases, the veterinarian is not acting as DMR, but is serving as a subject matter expert to verify that the proposed changes are appropriate for the animals and are consistent with relevant IACUC-approved policies. Consultation with the veterinarian must be documented.

Changes that may be approved by VVC include the following types of changes, provided that there is no increase in pain or distress and that all changes are approved in a pre-existing IACUC-approved policy, guidance document, formulary, or procedure:

1. Changes to compounds or dosage of Anesthetic, Analgesic, Sedative, and/or Experimental Agents

2. Changes in Euthanasia to another AVMA-approved method

3. Changes to the duration, frequency, and/or number of procedures performed when the procedure is already included in the approved protocol

4. Changes in route or volume of administration

5. Changes in strain (when requested with other changes that meet above criteria)

6. Changes in personnel (when requested with other changes that meet above criteria)

Examples and additional implementation guidelines to aid veterinarians in determination of verification of the above criteria can be found in Appendix I.

Approved reference documents can be found in Appendix II.

Section C: Administrative Changes

Amendments that may be handled administratively by the OAW include any of the following:

1. Correction of typographical errors

2. Correction of grammar

3. Contact information updates

4. Changes in funding that do not require additional merit review or changes to the approved protocols as defined in Sections A and B

5. Changes in housing of animals to any vivarium or space managed by the Department of Comparative Medicine or by the Washington National Primate Research Center

6. Changes in location for procedures or use of animals to any space that, within the previous twelve months, has been used for the proposed species and purpose and inspected by the IACUC, and that remains authorized by the IACUC

7. Changes in personnel, other than the PI, if such personnel meet the UW training requirements and are enrolled in Occupational Health and Safety programs

8. Changes in rodent strain if the new strain has no increased morbidity or mortality, and the new strain will require no additional monitoring

9. Small increases in animal numbers to be used in an experiment that was already approved in the protocol unless animals are needed due to unexpected morbidity or mortality

a. Small is defined as <10% of an experiment or not more than one animal, in the case of an experiment for which fewer than 10 animals were initially approved.

b. Investigators may use fewer animals than approved. This does not require IACUC or OAW approval, notification, consultation, or administrative handling.