Protocol Submission Guidelines
- Who Must Submit
- New Protocols
- Annual Renewals (1st and 2nd Year Review)
- Resubmission of a Protocol
- Submission Deadline
- Additional Information
- Designated Member Review
- Committee Action
- Contingency Response
- Reporting Responsibilities
- Protocol Status
An IACUC Proposal must be submitted by any investigator to use vertebrate animals in any activity regardless of the source of funding or format of the project submission. If any or all of the animal work is to be done at another institution, then proof that the proposal has been reviewed and approved by that institution’s animal care and use committee also must be provided. Pre-submittal consultation with the DCM veterinary staff is available and should be sought if proposed procedures may cause more than momentary or slight pain or distress to the animal. Contact the Division of Comparative Medicine at 202.687.1676 for an appointment.
All new protocols must be submitted through our online submission application, eSirius. Please contact the IACUC staff (email@example.com) for access to eSirius and to set up a training session on using eSirius.
Amendments must be submitted to make any changes to an existing protocol, i.e., requesting additional animals, adding personnel, adding a new title to an existing protocol or changing an existing protocol title, and modifying or adding a procedure.
On the first and second anniversary of your protocol, the IACUC office will send an Annual Review form. Please be sure to provide the name, office and emergency phone numbers of all persons handling animals on the protocol. Although this information may have previously been provided, it is necessary to keep the IACUC records current. Please note that this information will be kept confidential and will be used by the Division of Comparative Medicine staff in case of an emergency.
All 3-year renewal protocols must be submitted through our online submission application, eSirius. Please contact the IACUC staff (firstname.lastname@example.org) for access to eSirius and to set up a training session on using eSirius. 3-year renewal notices are generally sent out 120 days prior to the protocol’s expiration date. As the PI, you must respond to the expiration notice email by indicating your intentions to renew. You must submit your protocol by the deadline stated. If you need to submit a 3-year renewal, it must be submitted in eSirius at least 60 days prior to the expiring protocol’s expiration date. After final approval of the new protocol is given, the protocol number will remain the same. Not responding to the expiration notice can result in the inactivation of the protocol. If the protocol expires, you will no longer be authorized to perform work or use animals. Any animals that you still have will need to be transferred to another active protocol. All animals housed in the DCM must be assigned to an active, approved protocol. Extensions to expired protocols are not permitted by regulatory agencies or by GU.
The IACUC meets on the third Tuesday of the month. To be considered at the monthly meeting, a protocol must be entered and submitted through eSirius by 5 pm on the last Tuesday of each month. Any proposals submitted in eSirius after this time will not be reviewed until the following meeting. Please consult the IACUC Meeting Schedule page for the upcoming deadlines and meetings.
The Principal Investigator is responsible for providing sufficient information to the IACUC about the purpose and plan to use laboratory animals so that the committee may take a reasonable evaluation of the activity. Between submission and the formal review of the IACUC proposal, additional information or clarification may be requested from the Principal Investigator in an effort to facilitate the approval process.
When an investigator makes a Designated Member Review (DMR) request for review of a protocol or an amendment, the Chair will determine whether a request for DMR can be made to the committee. If DMR is appropriate, the Chair will assign IACUC members to perform the review (which may include a veterinarian). An e-mail is sent to all IACUC members notifying them that an investigator has made a request for DMR with related attachments). The IACUC members are asked to respond within 3-5 business days as to whether they approve use of DMR for the request or if they wish to use full Committee review. If no member requests full Committee review, then the assigned reviewers will review the protocol or amendment. The reviewers can approve the protocol or amendment, require modifications to secure approval or refer the protocol or amendment to the full Committee for review. Their decision must be unanimous. These reviewers cannot withhold approval. Once the reviewers make their comments, they are sent to the investigator for necessary revisions. Once the protocol or amendment is finalized, it can be submitted for final approval.
Principal Investigators are notified in writing of the IACUC action and may proceed with their activities only upon receipt of committee approval. The Division of Comparative Medicine staff is authorized to place animal orders only for individuals with approved proposals and only for the species and number indicated in the proposal.
Before a proposal can receive full approval status, responses to any contingencies voiced by the IACUC must be submitted by the Principal Investigator within 60 days of the contingency letter, or the proposal will be administratively inactivated.
The Principal Investigator is required to report any adverse developments to the Division of Comparative Medicine veterinary staff and must request permission from the IACUC to modify any aspect of the approved IACUC proposal by submission of an amended application specifying the changes intended. In addition, a Principal Investigator who wishes to make significant changes to an approved animal project which has PHS support must seek approval from the PHS awarding component (questions should be directed to the Grants Management Office).
Any questions regarding the status of an IACUC protocol (whether pending or approved) should be directed to the IACUC office (email@example.com)