UNC IACUC AMENDMENT GUIDELINES

MINOR AMENDMENTS

Review by the individual indicated in parentheses.

· Personnel Changes—other than investigator (IACUC Training and Compliance Unit)

• Title Changes/ Funding Changes (IACUC Administration)
• Change in number of animals, if less than or equal to 5% of the approved number and not in Pain Category E. Some exceptions to 5% limit may be made for the addition of transgenic lines. (Chair or Vice Chair)
• Additional drugs under item H of protocol if procedures are the same and drugs are not used to induce toxicity (Chair or Vice Chair)
• Change of strain of animals within a species (Chair or Vice Chair)

e.g. different knockouts or Sprague Dawley to Wistar

• Increase in duration of experiment if not a post-surgical protocol (Veterinarian)

e.g. follow animals for effects of drug from 2 weeks to 4 weeks

e.g. monitor spontaneous tumor development from 4 months to 8 months

• Method of bleeding, if IACUC approved method (Training and Compliance Coordinator)
• Minor changes in behavioral/ observation procedures (Chair or Vice Chair)

e.g. increasing observation period for locomotor activity from 5 to 10 minutes

(The above were selected because they are likely common changes that are usually benign without pain or suffering)

SIGNIFICANT AMENDMENTS

NOTE: All significant amendments are handled by designated review and assigned to the Chair or Vice Chair unless otherwise noted in parentheses

• Investigator transfers. Only between faculty members in good standing

• Method of euthanasia not including physical euthanasia (Veterinarian)
• Change of anesthetic agent if switch is to an approved regimen for the species (Veterinarian)
• Change in number of animals greater than 5% but less than or equal to 25% of the approved number
• Move to Pain Category E (Veterinarian)
• Changes in the degree of invasiveness of a procedure or discomfort to an animal
• Use or withholding of analgesics (Veterinarian)
• Changes in duration, frequency, or number of procedures performed on an animal

SIGNIFICANT AMENDMENTS REQUIRING A FULL APPLICATION

• Change in animal species
• Changes in animal number greater than 25%
• Changes in objectives of a study
• Addition of survival surgery (when no survival surgery described in original application)

Updated 08/28/02

Revised 02/25/04

Revised 11/18/05

NOTE: IACUC allows exceptions to these guidelines on a case-by-case basis with full Committee approval.