Modifications to Approved Protocols
Background
Animal Welfare Regulations require that investigators receive approval from the IACUC for all significant changes to approved animal research protocols, but provide little guidance with respect to the actual criteria for determining whether a change is significant or not. The IACUC has developed a policy to assist investigators regarding modifications to approved protocols.
Levels of Review
Changes to approved protocols fall into three categories:
- Minor changes (administrative review; Chair approval)
- Significant changes (designated review by subcommittee)
- Significant changes (full committee review)
Minor changes are reviewed by the IACUC Chair on a weekly basis. Examples of minor changes are:
- Addition of a funding source
- Addition of research assistants
Some significant changes to approved protocols may be eligible for Designated Review by a subcommittee of the IACUC that meets weekly. Examples of modifications eligible for Designated Review may be:
- Additional animals (less than 10% above the originally-allocated number)
- Refinement in surgical or experimental technique
- Addition of an experimental agent
- Change in euthanasia method
Modification requests that are submitted for Designated Review are forwarded to all voting members of the IACUC, who then have the opportunity to review the request and verify that it is suitable for subcommittee review. If no member objects to subcommittee review, the modification is reviewed the next time the subcommittee meets. NOTE: If any one member of the IACUC requests full committee review, the modification must be reviewed at a convened IACUC meeting.
Examples of significant changes that require full committee review include:
- Addition of a survival surgical procedure
- Requests for large numbers of additional animals (more than 10% of the originally approved allocation)
- Addition of any new procedure that increases the invasiveness or the amount of pain and distress the animals may experience.
NOTE: A fundamental change in the study design or methods may require submission as a new protocol.
Submission Procedures
- Read the UCI IACUC Protocol Modification Instructions and complete the Request for IACUC Protocol Modification, including a narrative description of the proposed change. Include detailed information about the change to the approved protocol, including the reason for making the change and the potential impact it could have on animal well-being.
- Prepare a revised version of the entire approved protocol, in which the proposed modification has been incorporated and highlighted to ensure that the additions and/or changes are clear to IACUC reviewers. NOTE: Lead Researchers and their staff are responsible for maintaining the current approved version of all animal protocols. Please review the Policy on Significant Changes to Approved Protocols for more details about this new requirement.
- Requests to modify approved IACUC protocols cannot be submitted via the web portal at this time. Modification requests may be submitted via email attachment by sending them directly to the IACUC administrative mailbox at IACUC@uci.edu or they can be delivered in hard copy via personal delivery or campus mail to the Office of Research Administration.
- For designated and full committee review, submit one signed original of the Modification Request Form and Narrative, plus an updated protocol narrative with the changes clearly highlighted to the IACUC Administrative Office. Modification requests received before 3:00 p.m. Friday may be eligible for subcommittee review the following Friday. The Lead Researcher will be notified once the required level of review is determined, and may be contacted for additional information or clarification as necessary.
- For minor changes such as the addition of a funding source or new research personnel, submit the original modification form only, along with a narrative explanation of the change and an updated/highlighted protocol narrative. For additional personnel, be sure to include a description of what role/responsibility each person will fulfill on the project and a description their relevant experience and/or training in the appropriate section of the updated protocol.
If you have questions or need assistance determining the level of review required by a modification request, please contact the IACUC Administrator at (949) 824-8170.
