IACUC Policy on Amendment Review Types for Approved ACUPs
Federal regulations (PHS Policy, Animal Welfare Act) and Institutional Policy require all procedures associated with animals be reviewed and approved by the IACUC prior to implementation or procurement of animals. This includes changes to approved animal care and use proposals (ACUPs). Principal Investigators are responsible to submit an amendment form to the IACUC in the appropriate timeframe to obtain this approval. Current amendment forms can be obtained on the IACUC website.
With the exception of the procedures or items described below, amendments will undergo the IACUC Designated or Full committee review process.
Changes to an approved ACUP relating solely to veterinary oversight, as described below, will follow the Veterinary Review process. In consultation with the Attending Veterinarian (AV) or designee (e.g., other qualified veterinarian with IACUC-defined program responsibility), the PI will prepare and submit amendments to the IACUC describing proposed changes to an approved ACUP. Approval will only be required from the AV or designee. These items will not undergo call for comment. The IACUC is provided information on approved changes to ACUPs at the next IACUC meeting.
- Increase of 20% or less of the approved animal number total
Increases of 20% or less of approved total (original + any amendment additions) for any species may be approved by veterinary review. Justification provided will be of the same nature as expected for IACUC approval. More than a 20% increase will follow the regular IACUC review process.
- Change in medication
The AV can prescribe medications to ensure humane treatment of individual animals, without the need for an amendment to be submitted. This would be noted in any health records maintained for these individual animals. If the AV or designee recommends these medications for all animals, then an amendment form should be submitted for Veterinary review.
Additionally, the AV or designee can recommend a change in any medication (antibiotic, analgesic, anesthetic, other), route of administration, or dose to benefit the animals in the approved ACUP. For experimental drugs, a change in route of administration and dose can be approved by Veterinary review, but new experimental drugs will be required to undergo IACUC review.
- Surgery-related changes
Changes in pre-operative procedures, suture material, suture type, location of surgical incision, and sterilization techniques can be approved by Veterinary review. An addition of a new surgery (minor or major) will require IACUC review.
- Blood collection
Changes in blood collection method, frequency, or volume can be approved by Veterinary review.
- Husbandry condition
Changes in diets, light cycles, or other housing conditions can be approved by veterinary review. If the change involves an approved experimental drug being administered in food or water, this change is discussed in the “Changes in medication” section. New experimental drugs need to undergo IACUC review. Exceptions to the “Guide” or regulatory requirements require IACUC review.
Change to an approved ACUP, as described below, will undergo Administrative Review. Approval will occur once IACUC staff confirm the requirements for each element have been met. These changes will not be included in the “call for comment” list and will be reported to the IACUC at the next monthly meeting.
- Personnel changes
Additions or deletions of personnel can be approved by the IACUC administrator. New personnel are required to complete IACUC required training and enroll in the Occupational Health Services (OHS) Animal Handler Medical Surveillance Program. Once these requirements have been completed, approval can be granted administratively and work with animals can initiate.
- Changes housing/procedure location
Additions or deletions in locations for animal housing or procedural performance can be approved administratively, provided the AV or designee has approved the location for the species to be housed or the procedure to be performed. Changes in Field Study locations are required to be identified to the IACUC in advance of collection; approval is needed from both the IACUC and any permitting agencies. If the proposed change involves hazardous agent use, the appropriate EH&S safety committee will be consulted. The change in housing/procedure location will be held until approval is received from the EH&S committee.
- Changes in funding
Adding, deleting, or updating information for a funding source can be approved administratively. The IACUC administrator will ensure that grant comparison occurs for federally funded projects, following IACUC requirements. If the grant comparison results in the need to include additional changes, the most appropriate amendment review will occur (Administrative, Veterinary, or IACUC) from the resulting changes. If there are no other changes, this will be approved administratively.
IACUC Approved April 2011