How do I make changes to an approved protocol?
All changes in animal use must be approved by the IACUC. Minor changes can be proposed through submission of a written Addendum to ammend an approved IACUC Protocol form has been created for this purpose and may be found on the forms page of the IACUC website add link or send a memo directly to the IACUC Office. Please provide a scientific justification for the changes requested.
Significant changes in animal use require application for a new protocol. Significant changes include:
- Changes in the aims or objectives of the study.
- Changes in procedures resulting in increased pain, distress or discomfort.
- A change from non-surgery to surgery, from minor to major surgery, from non-survival to survival surgery, or from single to multiple survival surgery.
- Changes in species to species higher on the phylogenetic scale.
- Addition of hazardous or infectious agent use.
These points are guidelines and are not meant to be exhaustive. Reviewers may request submission of a new protocol if they believe the proposed changes represent a significant deviation from the approved protocol.
Guidelines. In submitting an addendum, the justifications and descriptions of procedures must meet the standards used in preparation of a full protocol.
Where appropriate, the following information must be included in the addendum:
- An increase in estimated animal numbers must be justified by statistical methods or through a logical accounting of animal use.
- The expected clinical condition of the animals after the procedure must be made clear.
- If pain or distress will be involved, methods to relieve pain or distress must be described or the withholding of pain relief must be justified.
- The methods of euthanasia must be given.
- The plan for post procedural care and observation must be given.
- The criteria for interventional euthanasia must be given.
- The training and experience of the personnel performing the procedures must be given.
- The location where the procedures will be performed must be given.
Review.Addenda to protocols are reviewed by a veterinarian reviewer and by the chair of the IACUC.
No work may begin on a proposed addendum until final approval (IACUC Chair signature) is received by the principal investigator. |
