General Amendment Requests

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 such changes prior to implementation.

IACUC Policy

An amendment can be submitted via the eProtocol system or a General Amendment Form (only available for protocols that are not yet in eProtocol), which must be 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 (if applicable). The following are examples of common amendments with requirements:

  1. When modifying animal numbers – Include justification and add the animals to the Species table.
  2. When adding a different species, strain, or sex – Include the following information:

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.

b. if genetically engineered or mutant animals are requested, describe the following (in eProtocol these questions can be found in the "Animal Breeding, Housing and Care" section):

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

  1. When adding or changing housing or husbandry procedures – Describe details and attach an applicable husbandry agreement for outside housing requests.
  2.  When adding or modifying a breeding program – Provide the details of any new or changed breeding program. Include information on the disposition of any surplus offspring. Identify the final disposition of any foundation/breeder animals and how long they will be maintained in the study.
  3. When adding or modifying surgical or experimental procedures – Include a full description of the new/modified procedure, including any new pre-, intra-, or post-procedure care and anesthesia/analgesia regimen.
  4. If there are new animal health complications – Describe any new complications that may result from the proposed amendment.
  5. If there are euthanasia changes – Describe any new criteria and/or methods for early or planned euthanasia.
  6. If there are hazardous agents changes – Complete the "Are you using?" section. . Contact the WSU biosafety officer as soon as possible at 577-1200 if the use of CDC Select Agents is requested.
  7. If there is a change in procedure room(s) – Include the building and room number as part of the specific procedure(s).
  8. When adding/changing transportation of animals between WSU buildings or off campus locations – Justify and describe in the "Animal Breeding, Housing and Care" section.
  9. When adding or changing a funding source – Attach the associated grant/proposal and incorporate all changes, if applicable.

 

Approved: November 2006

Revisions Approved: 8/2008, 12/2012, 12/2017