Amendments to a Protocol
Any change in a project involving animals requires additional review by the Institutional Animal Care and Use Committee (IACUC) and may not be undertaken until approval has been granted. Changes may include, but are not limited to, any of the following:
- Numbers of animals
- Anesthetics or other drugs
- Disposition (including method of euthanasia) of animals at the end of the study.
All amendments must be made in the Online Protocols System. Approved protocols are accessible by the PI and senior staff for editing and additional separate amendment forms are not necessary. Amendments are considered either "minor" or "significant" depending on the requested change. When submitting the amendment, the PI or senior staff will not need to make a distinction between minor and significant changes. Changes will be assessed and categorized by the IACUC staff. If changes are considered significant, the PI will be notified that a review by the committee is required.
- Find the protocol in the dashboard of the Online Protocols System.
- Make changes to each section as needed. Any changes made to text boxes will be highlighted automatically. If adding personnel, remember to complete their procedures and experience information in Section 17, in addition to adding their names to the title page. Personnel will not be approved until training is complete. Incomplete/expired training will be immediately obvious as each person is added.
- Click “Submit” after completing your changes and a text box will pop up. Summarize the requested changes and their rationale in the text box.
- If any additional information is needed, the PI will be notified via email from the messaging system internal to the system. Please follow the instructions in the notification and respond within the system.
Reviews of significant amendments by the IACUC are similar to reviews of full protocols and may take three to four weeks to complete. Some amendments may require review at a convened meeting of the IACUC. Meetings are scheduled for the first Tuesday of every month (the second Tuesday if a holiday occurs in the first week).
Examples of Minor Amendments
- Changes to the title of a protocol or a funding source
- Adding a new strain or genetic background of an animal
- An addition of animals to your protocol that does not exceed 10% of the originally approved number of animals for that species
- Change in an animal care facility, housing unit, or field site
- Change in the administration of experiment/treatment as it relates to the timing, dose, route of administration and/or specific chemical composition if no increase in invasiveness or risk to the animal for pain or distress
- Addition or removal of personnel other than the PI
Examples of Significant Amendments
- Change from non-survival to survival surgery
- Change resulting in greater pain, distress, or degree of invasiveness
- Change in housing and/or use of animals in a location that is not part of the animal program overseen by the IACUC
- Change in species
- Change in study objectives
- Change that impacts personnel safety
If a very significant change to an approved protocol is required, a new protocol MUST be submitted. Such protocols will be reviewed as new (early renewal) protocols and should be written with these in mind:
- All procedures and experiments that have been completed should be removed.
- Animal numbers requested should reflect ongoing work transferred to the new protocol as well as work planned for the next three years.
- There is no need to indicate what procedures or experiments would have constituted your significant amendment.
- The current protocol will remain in effect only until the renewal is approved.