Policies

Policy on Processing and Approving Protocol Amendments

Institutional Animal Care & Use Committee
Jun 4, 2018 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.

  • Policy

    1. Administrative Amendments

    1. Certain protocol changes have no impact on animal activities and are considered administrative amendments. Administrative changes can be made to IACUC approved protocols by any member of the Animal Care and Use Office (ACUO). The following protocol amendments may be made by administrative staff:

                                   i.    Changes in personnel and personnel information, other than the PI;

                                  ii.    Correction of typographical or grammatical errors;

                                 iii.    Personnel contact information updates;

                                 iv.    Changes in funding sources; and

                                  v.    A 10% or less increase in mice or rats.

    2. Veterinary Verification and Consultation (VVC)

    1. OLAW notice NOT-OD-14-126: “Guidance on Significant Changes to Animal Activities” defines an administrative process that can be used to make certain significant changes to IACUC approved protocols. The IACUC has approved specific changes that can be incorporated into IACUC approved protocols by ULAM Faculty Veterinarians that are either IACUC voting or alternate members using the VVC process. The following changes can be made to animal activities that have already been IACUC approved provided that the proposed change does not increase pain, distress or degree of invasiveness:

                                   i.    Modification or refinement of pain relieving medications provided the changes are consistent with the guidance listed as resources below;

                                  ii.    A modification of a surgical procedure that reduces the invasiveness or discomfort of the process;

                                 iii.    Modifications to genotyping and identification procedures provided the changes are consistent with the guidance listed as resources below;

                                 iv.    Pre or post-operative procedures that are consistent with the IACUC approved Guidelines or Policies referenced below;

                                  v.    Method of euthanasia as long as any refinements are consistent with acceptable methods described in the American Veterinary Medical Association (AVMA) panel
                                         publication on acceptable methods for euthanizing vertebrate animals.  

                                  vi.    Change to a non-pharmaceutical grade compound (from a pharmaceutical grade equivalent) due to unavailability or shortage of the pharmaceutical grade version. 

    3. Significant Changes to IACUC Approved Protocols

    1. Any significant change not described above must be reviewed and approved using IACUC Review.
  • Related Documents

    • Nonhuman Primate Anesthesia & Analgesia Guidelines
    • Swine Anesthesia & Analgesia Guidelines
  • Additional Resources