Review Procedures for Significant Changes in an Approved Protocol
Changes in vertebrate animal use in research and teaching are inevitable. The principal investigator (PI) is responsible for informing the IACUC of any significant changes by submitting an amendment to an approved protocol. Protocol changes categorized as significant cannot be implemented prior to IACUC review and approval. Amendments including significant changes will be reviewed per the standard operating procedures for protocol and amendment review.
Significant Change Examples
- Change in PI
- Changes in the objectives of a study
- Proposal to switch from nonsurvival to survival surgery
- Increased degree of invasiveness of a procedure, or increased duration, frequency or number of procedures performed on an animal
- New experimental substances or changes to the dose, route, concentration, volume, and/or duration of an experimental substance that has already been approved with documentation of expected effects and lack of adverse clinical consequences and Environmental Health and Safety approval of appropriate personal protective equipment/measures.
- Any change with the potential for increased pain or distress
- Any change in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC
- Change in species
- More than 10% increase in the number of non-USDA regulated animals used; any increase in a USDA-regulated species
- Changes in veterinary medical care, such as the use or withholding of analgesics and methods of euthanasia
- Certain changes in the use of hazardous substances or changes that impact personnel safety.
Revised November 2023