BACKGROUND

The Institutional Animal Care and Use Committee recognizes that investigators may periodically need to make changes in their protocols after the Committee has granted final approval. Regulatory agencies require that the Institutional Animal Care and Use Committee approve all significant changes prior to implementation (additional information can be found in the Review of Significant Changes to Approved Protocols SOP).

IACUC Policy

An amendment must be submitted via the eProtocol system. Amendments are reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). If during the review of the amendment request, it is determined that the requested change does not qualify as an amendment, a new IACUC Protocol Application must be submitted to the IACUC. Approved amendments expire on the same date as the parent protocol.

IACUC Guidelines

All amendments must be incorporated into the appropriate sections of eProtocol. The following are examples of common amendments with requirements, some of which may be able to be approved administratively or by Veterinary Verification and Consultation (VVC) depending on requirements outlined in the Review of Significant Changes to Approved Protocols SOP:

1. When modifying animal numbers Add the animals to the table in the Species section and provide justification in question 2.
2. When adding a different species, strain, or sex Modify the table and question 2 in the Species section and also include the details in the following sections (when applicable):
   1. Animal Use Justification section, question 1.c.i. Include a description of the biological characteristics (e.g., unique anatomic, physiologic, age or sex related characteristic or attribute) that make the animals requested the most appropriate for the described work.
   2.  Animal Breeding, Housing and Care section, question 3 if genetically engineered or mutant animals are requested. Describe the following:
      1. the genetic modification
      2. the anticipated phenotypic and physiologic consequences
      3. the method of monitoring presence of gene modification in animals and when it will be done
      4. any special care or monitoring required
      5. the scientifically-recognized nomenclature for all genetically engineered and mutant animals and source from which they will be obtained
3. When adding or modifying surgical or experimental procedures Add the procedure(s) in the Procedures section and include a full description of the new/modified procedure under Procedures (Surgical) or in the Non-Surgical Procedures Details section..
4. If there are new animal health complications Describe any new complications that may result from the proposed amendment in the applicable section(s).
5. If there are euthanasia changes Describe any new criteria and/or methods for early or planned euthanasia in the Euthanasia section.
6. If there are hazardous agents' changes Revise the Are you using? section.
   1. Contact the Wayne State University biosafety officer as soon as possible at 577-1200 if Institutional Biosafety Committee (IBC) approval is required for work with the agent being added.
7. If there is a change in procedure room(s) Include the building and room number as part of the specific procedure(s) in the Procedures section. Specific rooms in a DLAR facility are not required. If a laboratory will be used for procedures, the room number must be provided.
8. When adding/changing transportation of animals between Wayne State buildings or off campus locations Justify and describe in in the Animal Breeding, Housing and Care section, question 10.
9. When adding or changing a funding source Add the information in the Funding section, and incorporate all changes.

Approved: November 2006

Revisions Approved: August 2008, December 2012, December 2017, June 2021, July 2022