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. If the IACUC office determines that the proposed protocol changes are significant, the amendment will be assigned to an approved veterinary pre-reviewer and another IACUC member pre-reviewer. In some cases, the pre-reviewers and the IACUC chair may determine that changes are sufficiently different from the original protocol and that a new application should be submitted. In all other respects, the IACUC’s review of amendments including significant changes is the same as the review of a new protocol application. When the pre-review has been completed, the proposed amendment is sent to each IACUC member to permit an opportunity to request additional information or convened IACUC review.

Significant changes include but are not limited to:

  • 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 22, 2019