Laboratory Animal Care Service
Alterations to previously approved protocols

The Institutional Animal Care and Use Committee (IACUC) has considered conditions under which investigators and personnel in teaching laboratories might be free to change experimental protocols previously approved by the IACUC. A distinction was made between manipulations performed on animals just before death and procedures on animals expected to survive. The same approach was used for identifying investigator latitude in both instances. First, a category of "minor changes" was identified, for which no approval or review by the IACUC would be required. For a second category, "moderate changes", an investigator must submit a protocol addendum to the IACUC Chairman. The final category, "major changes", consists of alterations in experimental procedure that would require the submission of a new protocol for approval. The IACUC believes these provisions provide reasonable flexibility within federal regulatory requirements. If an investigator has any questions, they should contact the Chair of the IACUC.

Conditions of Terminal Surgery/Euthanasia

Minor changes (no additional IACUC approval required)

1. Harvesting additional tissues
2. Taking additional measurements
3. A longer procedure (provided anesthesia is adequate if applicable)
4. Additional surgical manipulations if nonsurvival surgery
5. Increase (10% or less) in the number of animals

Moderate changes (addendum request in the form of a letter to IACUC Chair)

1. Altering the anesthesia procedure
2. Altering the method of euthanasia
3. Minor species change (e.g., mice to rats, etc.) or an increase greater than 10% but less than 25% in the number of animals to be utilized.

Major changes (new protocol approval required)

1. Change in experiment (e.g., if the experiment was originally approved for kidney studies but the investigator plans to do brain surgeries instead
2. Major change in species (e.g., from rodent to carnivore) or an increase greater than 25% in the number of animals

Conditions of Survival

Minor changes (no additional IACUC approval required)

1. Altering schedule
2. Additional sampling, or further minor surgery, provided that the new procedures do not involve more distress than procedures already approved (e.g., adding an intravenous glucose tolerance test to a protocol that already involves repeated blood sampling; also, adding a venous catheter to a protocol that already involves arterial catheterization; electrically stimulating additional or different nerves when such stimulation has already been approved; adding blood sampling to a protocol that already involves surgery)
3. An increase (less than 10%) in the number of animals

Moderate changes (addendum request in the form of a letter to IACUC Chair)

1. Adding minor surgery to an experiment that already involves anesthesia (e.g., subcutaneous fat or muscle biopsy)
2. Altering surgical approach (e.g., paramedian approach instead of ventral midline approach)
3. Changing analgesics, anesthetics, sutures, etc.
4. Minor species change (e.g., mice to rats, etc.) or an increase greater than 10% but less than 25% in the number of animals to be utilized.
5. Series of minor changes (see above)

Major changes (new protocol approval required)

1. Performing major surgical procedures more frequently than proposed (e.g., renal wedge biopsy)
2. Adding anesthesia and/or surgery (major and minor) when a protocol does not already include these items
3. Major scientific changes (e.g., if an investigator can complete the approved studies on a smaller number of animals than proposed, he cannot use the remaining animals for unapproved purposes)
4. Major change in species (e.g., from rodent to carnivore) or an increase greater than 25% in the number of animals
5. Procedures that alter the survival of the animals (e.g., survival of animals originally scheduled to be euthanized; changes in survival surgery resulting in a more difficult postsurgical course)
6. Multiple moderate changes to protocol (see above)

Kansas State University | Laboratory Animal Care Service