Once the IACUC has approved a project, the project must be conducted as approved. The investigator and the IACUC have additional responsibilities after approval of the protocol.
Amendments
The amendment submissions should be made within the eProtocol application form by opening the form up for editing and then choosing "start an amendment submission". The first page will then be a standard amendment form asking about the changes requested. Please then make the subsequent changes to the following pages of the already-approved protocol form or attach needed documentation within the "attachments" tab.
The IACUC may ask for revisions to the amendment materials. You may not initiate the protocol changes until you receive written notification of approval for the revisions from the IACUC.
Renewals
Approved protocols MUST be reviewed annually, and if the protocol will continue past the three-year anniversary it must be resubmitted in full as a new protocol. In order to renew the protocol, you must complete and submit the renewal form to the IACUC electronically via the eProtocol online submission system. You must be sure to submit the renewal or resubmission with sufficient time for review to ensure that the protocol is reviewed before the end of the annual review period. The IACUC cannot extend the protocol approval past the expiration date indicated in the approval letter.
Closure
Once the project is completed you must notify the IACUC and officially close the protocol. The renewal form should be used to provide this report and the investigator should be sure to include:
- The number of animals used during the last annual approval period (i.e., since the last annual renewal form was submitted) and the TOTAL number of animals used for the study
- A summary of the results to date
- A listing of any publications resulting from the work
- The disposition of animals used for the protocol. Animals cannot be housed under an expired or approved protocol; therefore, animals must be transferred to another approved protocol or humanely euthanized before you close a protocol.
Post-Approval Monitoring
The IACUC meets with individual investigators to discuss their concerns and questions about the Guide, but also to talk to investigators to better understand their research protocols and any animal care issues for a particular protocol. These meetings are intended to be educational for the IACUC members, as well as for the investigators. In addition, the IACUC conducts post-approval monitoring activities including the review of protocols at the time of renewal, during routine veterinarian care and treatment visits to the facility.