Policies

Policy on Processing and Approving Protocol Amendments

Institutional Animal Care & Use Committee
Jun 3, 2019 12:00 pm

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 modify the protocol depends on the proposed change.

  • Background

    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 modify the protocol depends on the proposed change.

  • Applicability

    This policy is applicable to animal activities that are conducted under the auspices of the U-M and under the oversight of the U-M IACUC.  It applies to field studies as well as all campus locations, including Ann Arbor, Flint and Dearborn. 

  • Definitions

    1. Minor Amendments – specific protocol amendments that have no impact on the health and welfare of animals  
    2. Verify - means that a veterinarian determines that based on his or her experience and training, 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 an IACUC voting or alternate member
    4. VVC process – a practice that can be used to make significant changes to an animal activity within an IACUC approved protocol providing the change does not increase the pain and/or distress animals will experience
  • Policy

    1. Minor Amendments

    This policy authorizes Animal Care and 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 providing that change does not exceed more than 10% of the originally IACUC approved number

    2. Veterinary Verification and Consultation (VVC) Changes

    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, verify that the significant changes being considered are consistent with VVC policy, and make final changes to the protocol.  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 the clinical and humane requirements as well as the needs of the research protocol, and meets the 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 providing 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; and
    6. Changes between blood collection methods (route, frequency, volume) providing the techniques are less or equally invasive and appropriate for the species as determined by the veterinarian

    3. Significant Changes IACUC Approved Protocols

    Changes to protocols that are not considered minor, or 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 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.

    Compliance

    This policy is under the discretion of the IACUC, and is implemented through the ACUO.The IACUC has the authority to enforce the provisions of this policy, and if necessary suspend research, or implement appropriate sanctions.