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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
  • any change with the potential for increased pain or distress
  • change in species
  • significant (i.e., more than 10%) increase in the number of nonregulated animals used; for a USDA-regulated species, any increase is considered a significant change
  • 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

Revised April 2019