In order to make changes to an already approved IACUC protocol, the PI needs to ensure personnel requirements are completed and to email a Protocol Amendment Form(.docx) to the IACUC office.
The Protocol Amendment Form is used for changes such as:
- Adding personnel to a research protocol (section A).
- Submitting minor changes to an active protocol (i.e., changes in animal use sites, changes in purpose or objective, section B).
- Adding funding.
- Making changes to other items such as tasks and techniques, additional animals, new or increased risks and/or hazards, different anesthetics agents, etc.
Do not begin activities until you have received final IACUC approval for your proposed amendment. Doing so would be considered research misconduct and non-compliance.
Once the amendment is received by the IACUC office, it goes to the IACUC committee for further processing. Some amendments, (e.g., personnel additions and funding) can be reviewed and approved by the IACUC office without involving the committee.
If the proposed modifications are significant, the IACUC may require the researcher to submit an entirely new protocol. If you have any questions about whether the changes you want to incorporate will necessitate a new protocol, contact the IACUC office.
The Protocol Amendment Form cannot be used to extend approval periods.
A de novo application must be submitted instead. If this renewal protocol has not been processed and approved by the expiration date, the IACUC approval for the work will expire and all activities involving the care and use of animals must cease immediately. Any activities conducted under the protocol after expiration will be in direct violation of federal regulations and institutional and IACUC policies.
Review timeline
The time it takes to receive IACUC feedback on your submission depends on the completeness of the submission, the complexity of the research, and the volume of protocols already under review at the time your submission is received. The following are estimates only:
- Personnel amendments: ~1 week
- Other amendments: ~2 weeks