# Forms & Submission ## expand\_more ## Submission Process ![Image of the IACUC review process](/sites/g/files/omnuum5396/files/styles/hwp_1_1__720x720_scale/public/2024-10/Review%20Process.png?itok=LZ-i-Jq5) Read the [Accessing E-IACUC](https://prod-hmaiacuc.drupalsites.harvard.edu/accessing-e-iacuc) section to learn how to create a **new protocol**, **amendment**, or **three year renewal**. Be sure to submit proposals for IACUC review using the **Submit Study/Amendment** activity; this will move them out of the *Pre-Submission* state and begin the review process. You must wait for the IACUC to **notify** you of approval before starting animal work - E-IACUC will automatically generate an approval letter and send out an email notification upon approval. Contact the [Office of the IACUC](mailto:IACUC@hms.harvard.edu) for confirmation if unsure. ### Pre-Review - **Administrative Review**: All submissions will first be reviewed by one of the Protocol Liaisons (PLs) from the Office of the IACUC. The PL will review the proposal for completeness and request clarification on items the veterinary or IACUC reviewers may want more information about. - **Ancillary Review**: The PL may send the submission to additional, specialized reviewers as needed, such as chemical-, radiation-, or biosafety teams. Ancillary reviews may request modifications to the proposal or specify safety procedures to be followed. - **Veterinary Review**: After administrative review, the submission is reviewed by a veterinarian, who will advise the IACUC and PI on matters relating to clinical care. The lab shall address any recommended changes - respond directly to each comment, modify/edit the proposal as appropriate, and resubmit it to continue the review process. Objections to a particular veterinary recommendation, due to experimental or other reasons, should be addressed similarly. ### IACUC Review Once all comments have been addressed to the satisfaction of the reviewing veterinarian, the PL will send the proposal to the committee to determine whether it will be reviewed by Designated Member Review (DMR) or Full Committee Review (FCR). DMR and FCR are the only protocol review methods that fulfill federal requirements. - **Designated Member Review**: The PL will distribute the proposal to the IACUC, giving all members an *opportunity to request FCR*. If no requests for FCR are made within 48 hours (24 hours for emergency submissions), the IACUC Chair will delegate 1-2 committee members to review the submission. The assigned reviewer(s) will may (1) approve the proposal, (2) request modifications in order to secure approval, or (3) request that the submission is sent for FCR. If even one member of the IACUC requests FCR, the submission will need to be reviewed at the next available convened IACUC meeting. - **Full Committee Review**: The PL will distribute the submission to the IACUC for review during a convened meeting of a quorum of the IACUC members, and with a formal vote. After the meeting, the PL will relay the IACUC’s recommendations to the PI and contact person: (1) approval, (2) request for modifications to secure approval, or (3) withhold approval. If modifications are required following either DMR or FCR, then the lab shall address any concerns - respond directly to each comment, modify/edit the proposal as appropriate, and resubmit it to continue the review process. A designated committee member may review the response and choose to (1) approve the protocol, (2) request further modifications, or (3) send the revisions to the next full committee meeting. Once approval is granted, the PL will notify the investigator and contact person. ### Still have questions? Contact the [Office of the IACUC](mailto:IACUC@hms.harvard.edu) at any time before or during the IACUC review process.