The Public Health Service (PHS) Policy (IV,B,7) and Animal Welfare Act Regulations (AWAR) require PIs to seek Institutional Animal Care and Use Committee approval for modifications to ongoing animal care and use activities prior to initiation. The protocol amendment process provides an opportunity for an investigator to modify an approved protocol at times other than when regularly scheduled continuing protocol reviews occur.
Significant changes include changes that have, or have the potential to have, a negative impact on animal welfare. Specific significant changes may be handled administratively according to IACUC-reviewed and approved policies in consultation with veterinary staff. An amendment is evaluated in conjunction with the original protocol to adequately determine if a significant change has been proposed. If in doubt whether a proposed change is "significant" from the point of view of animal welfare, please consult veterinary staff or the UAWC Chair.
The UAWC’s procedure for modifying a protocol is the following:
- The PI completes the amendment form describing the proposed changes to the protocol.
- The amendment form is submitted to the email@example.com alias and evaluated by the UAWC Chair and Attending Veterinarian. This evaluation will determine if the proposed changes are significant and require full committee review or if the changes can be approved administratively by the Chair or Administrator.
- The PI is informed of the determination and if the amendment requires full committee review, it will be given a pre-review by the Chair, her designee, or a faculty reviewer on the UAWC. In either case, the PI will make the requested changes to the amendment and resubmit to the Administrator with the tracked changes left on, so it is clear to the reviewer(s) what changes were requested and how those changes were addressed.
- If the amendment requires full committee review, the investigator should resubmit the requested documents by the appropriate submission deadline. If the amendment can be approved administratively, official approval is processed upon receipt of confirmation from the reviewer. Once PI receives UAWC approval, their change may be implemented immediately.
- The PI provides a signed hard copy of the approved amendment to the Administrator for record.
Examples of change in animal use procedures that could affect animal welfare and are generally considered to be major (significant), possibly warranting full UAWC review are:
- Change in purpose, specific aim or objectives of a study.
- Change in protocol that would require an animal to undergo more than one survival surgery.
- 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.
- Change in protocol where death becomes the experimental end point.
Examples of changes considered to be minor which can typically be approved administratively are:
- Addition of another strain of the same animal species
- Change in sex of animal to be used
- Small increase in animal numbers
- Need to repeat an experiment
- Addition of minor surgery
- Addition of sample collection times
- Additional noninvasive sampling
- Replacing a procedure with another less painful, stressful or hazardous that achieves the same specific objectives
- Changing experimental design to reduce the use of animals
- Addition of a funding source
- Removing a proposed experiment from a protocol.
- Updating the alternatives section of a protocol (including Policy 12).
- Changing or adding analgesia or anesthetic on veterinary recommendation.
- Correction of typographical errors
- Correction of grammatical errors
- Contact Information Updates
- Change in personnel, other than the PI
You may contact the UAWC Administrator or veterinary staff for assistance with completion.