Policy on Processing and Approving Protocol Amendments

Institutional Animal Care and Use Committee (IACUC) approved animal activities (i.e., protocols) can be amended using IACUC reviews and administrative processes (e.g., Veterinary Verification and Consultation, and Administrative Amendments). The method used to review and approve  changes to the approved protocol depends on the proposed modification(s).

This policy is applicable to all animal activities conducted under the auspices of the University and applies to all locations under the purview of the U-M IACUC.

1. Minor Amendments – changes to aspects of an IACUC approved protocol that may be handled administratively; these modifications have no impact on the health and welfare of animals
2. Verify – a veterinarian determines, based on their experience and training, that the proposed significant change is reasonable for a particular animal or group of animals in a particular situation and meets the parameters of this IACUC reviewed and approved policy
3. Veterinarian – any Unit for Laboratory Animal Medicine (ULAM) faculty veterinarian that is either designated as an IACUC voting or alternate member
4. Veterinary Verification and Consultation (VVC) Process – a practice that can be used to make significant changes to an animal activity within an IACUC approved protocol provided the change does not increase the pain, distress, or degree of invasiveness animals will experience

This policy authorizes Animal Care & Use Office (ACUO) staff members to use their professional judgment to make appropriate updates to IACUC approved protocols. The following protocol updates may be made by ACUO staff members:

1. Changes in funding sources;
2. Changes in housing and/or procedure room locations;
3. Changes in personnel and personnel information, other than the PI;
4. Changes due to typographical or grammatical errors; and
5. Changes in the approved number of mice or rats on a protocol provided that the change does not exceed 10% of the original IACUC approved number

OLAW notice NOT-OD-14-126: “Guidance on Significant Changes to Animal Activities” defines an administrative process that can be used to make specific significant changes to IACUC approved protocols.

This policy authorizes veterinarians to use their professional judgment to make significant changes to previously approved animal activities after verifying the requested change is one that has been previously reviewed and approved by the IACUC under this policy.

The VVC process allows the veterinarian to consult with the PI and verify that the significant changes being considered are consistent with VVC policy. Once verified, the significant change is considered approved, however, the change(s) must still be captured in the associated IACUC protocol(s).

The following significant changes have been reviewed and approved as part of this policy and, as a result, subsequent changes can be made to IACUC approved animal activities if the proposed change does not increase pain, distress, or the degree of invasiveness:

1. Changes in pain management drugs (i.e., anesthesia and/or analgesia) to ensure the approved plan continues to meet clinical and humane requirements as well as the needs of the research protocol, and meets acceptable veterinary standards;
2. Enhancements to surgical procedures, including pre or post-operative procedures, that reduce the invasiveness or discomfort of the process;
3. Modifications to the process of collecting tissue samples that are used for genotyping and/or identification purposes;
4. Changes in the methods of euthanasia provided that the changes are consistent with the acceptable methods described in the American Veterinary Medical Association (AVMA) panel publication on acceptable methods for euthanizing vertebrate animals;
5. Changes in the duration, frequency, type, or number of procedures performed on an animal;
6. Changes between blood collection methods (route, frequency, volume) provided that the techniques are less or equally invasive and appropriate for the species as determined by the veterinarian; and
7. Enhancements to trio-breeding that include trio-birthing for breeding arrangements to improve breeding outcomes.

Changes to protocols that are not considered minor, or that cannot be made using the VVC process, must be reviewed and approved by the IACUC using either the designated member or full committee review process. Some examples of significant change(s) that require IACUC review and approval include:

1. Changing from non-survival to survival surgery;
2. Procedures that result in greater pain, distress, or degree of invasiveness;
3. Changes in housing and/or the use of animals in a location that is not part of the animal program overseen by the IACUC;
4. Changes in species;
5. Changes in study objectives;
6. Changes in the PI; and
7. Changes that impact personnel safety.

The provisions of this policy are under the direction and oversight of the U-M’s IACUC. The IACUC will, if necessary, suspend research or implement sanctions if policy infractions should occur.

National Institutes of Health. Guidance on Significant Changes to Animal Activities. Notice NOT-OD-14-126. (National Institutes of Health, Washington, DC, 26 August 2014).

University of Michigan Euthanasia Guidelines