Protocol Submission Guidelines
- Who Must Submit
- New Protocols
- Amendments
- Amendment: Designated Member Review and Veterinary Verification and Consultation
- Annual Renewals (1st and 2nd Year Review)
- Resubmission of a Protocol
- Submission Deadline
- Additional Information
- 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. Please click this link IACUC Policy: Principal Investigator Eligibility and Responsibilities (new window) for specifics on who is allowed to be a PI at Georgetown.
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, Cayuse/eSirius. Please contact the IACUC staff (guacuc@georgetown.edu) for access to Cayuse/eSirius and to set up a training session on using Cayuse/eSirius.
For tips on how to properly complete sections of the protocol, please read this article “Everything You Need to Know About Satisfying IACUC Protocol Requirements” (new window)
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. No work may be completed until the amendment is approved.
4. Amendment: Designated Member Review and Veterinary Verification and Consultation
All Amendment submissions are directed into one of the following review processes; Administrative, VVC, DMR, FCR and must be submitted in Cayuse. No change may be implemented without approval. All amendments will be processed using the most appropriate review process see IACUC Policy Amendment Types and Review Processes.
When an investigator submits an amendment it is determined if the amendment meets the requirements for Designated Member Review (DMR). 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 weekly, with related attachments, notifying them an investigator has made a request that is eligible for DMR. The IACUC members are asked to respond within 2 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 amendment. The reviewers can approve the amendment, require modifications to secure approval or refer the amendment to the full Committee for review. Their decision must be unanimous. These reviewers cannot withhold approval. Once the DMR request has been approved and the reviewers have made their comments, the comments are sent to the investigator for necessary revisions. Once all revisions have been accepted by the DMR reviewers the amendment will be approved.
When an investigator submits an amendment, it is determined if the amendment meets the requirements for Veterinary Verification and Consultation (VVC); see IACUC Policy Veterinary Verification and Consultation. If VVC is appropriate, the amendment will be sent to the attending veterinarian or a veterinarian designated by the AV. If any revisions are needed these will be provided to the PI in Cayuse. Once all revisions have been accepted, the amendment will be approved.
5. Annual Renewals (1st and 2nd Year Reviews)-USDA Species Only
On the first and second anniversary of your protocol, the IACUC office will send an Annual Review form. Please be sure all personnel contact information is up to date. 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.
6. Three-Year Resubmission of a Protocol
All 3-year renewal protocols must be submitted through our online submission application, Cayuse/eSirius. Please contact the IACUC staff (guacuc@georgetown.edu) for access to Cayuse/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 Cayuse/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 Cayuse/eSirius by 5 pm on the last Tuesday of each month. Any proposals submitted in Cayuse/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.
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 protocols and only for the species and number indicated in the protocol.
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 notification or the proposal will be administratively inactivated.
11. Reporting Responsibilities
The Principal Investigator is required to report any adverse developments as soon as possible (see IACUC Policy Animal Welfare, Noncompliance and Adverse Event Concerns) and must request permission from the IACUC to modify any aspect of the approved IACUC proposal by submission of an amendment specifying the changes intended. PIs should contact DCM veterinarians for any immediate animal welfare concerns. In addition, a Principal Investigator who wishes to make significant changes to an approved animal project should also contact their funding agency to ensure that additional approval is not needed before beginning any new work. (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 (guacuc@georgetown.edu)