How should protocol amendments that alter animal numbers or procedures be handled?

• A. They can be implemented immediately without review.
• B. They must be submitted after the study ends.
• C. They require IACUC review and approval prior to implementation; may involve FCR, DMR or AR depending on the change.
• D. They require IO approval only.

Answer: (C)

Changes to an approved protocol that affect how many animals are used or what will be done to them must be reviewed and approved by the IACUC before the changes are put into practice. This oversight protects animal welfare and the scientific integrity of the study by ensuring the numbers are justified, the procedures are appropriate and humane endpoints are still in place, and the overall plan remains compliant with regulations and policy.

When such amendments are filed, the IACUC assesses the potential impact of the changes and may request additional documentation or oversight. The path taken depends on the nature of the change: facility-related changes typically require a Facility Change Request; alterations to the experimental procedures or deviations from the approved methods may require a Detailed Modification Report; some minor administrative updates might go through Administrative Review. The essential point is that nothing altered in the protocol should be implemented until the IACUC has reviewed and approved the amendment.