Major Changes
Examples of change in animal use procedures that could affect animal welfare and are generally considered to be major (significant), therefore warranting full UAWC review:
Note: Previously, a significant modification required a full rewrite of the protocol. The appendix method can now be used for major amendments, requiring only that the sections of the protocol document to be updated are noted on the form. Major revisions must still be reviewed by the full UAWC.
- Change in purpose, specific aim or objectives of a study.
- Switching from nonsurvival to survival surgery.
- Change in protocol that would require an animal to undergo more than one survival surgery.
- Change in protocol that would require animals to be fed, housed or cared for in a way that is not standard for that species, or does not meet that species' minimum requirements.
- Increase in the degree of invasiveness of a procedure or discomfort to an animal.
- Change in protocol that would eliminate or restrict an animal's access to veterinary care.
- Change of species.
- Addition of USDA-regulated species.
- Significant increase in number of animals used over that projected: for example, an increase of 20% for projects approved for greater than 20 animals, or, an increase of 3 animals for projects approved for 6 to 20 animals, or, an increase of I animal for projects approved for 5 or fewer animals.
- Anesthetic agent(s), the use or withholding of analgesics.
- Change in methods of euthanasia.
- The duration, frequency, or number of procedures performed on an animal.
- Addition of survival surgery.
- Addition of a painful procedure.
- Change in protocol where death becomes the experimental end point. For purposes of this criterion, death is defined as natural death resulting from experimental conditions (rather than euthanasia at a time when a set of criteria recognized as the end point is met).
- Unanticipated marked increase in clinical signs or proportion of animal deaths