Georgetown University - GUACUC




				Office of Regulatory Affairs GEORGETOWN UNIVERSITY ANIMAL CARE AND USE COMMITTEE (GUACUC)

	GUACUC Home GUACUC Mission GUACUC Membership GUACUC Protocol Submission Guidelines Guidelines for Investigators Guidelines for GUACUC Members GUACUC Forms Study Specific Disclosure Form GUACUC Meeting Schedule GUACUC Policies Training Division of Comparative Medicine Manual for the Care and Use of Laboratory Animals at Georgetown University (the manual will open in a new window) Accreditation Information Occupational Health Information			Guidelines for Submitting a Proposal to Use Laboratory Animals in Research and Teaching Who Must Submit New Protocols Amendments 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 1. Who Must Submit A GUACUC 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. Presubmittal 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. 2. New Protocols New protocols must be on the application forms provided on the GUACUC Forms page of this site and be signed by the Department Chair. The GUACUC office cannot accept original materials such as magazines, booklets, or any two-sided documents. The Principal Investigator (PI) must first copy these documents before submitting them. All personnel handling animals must be listed on the protocol. Protocols will not be accepted on old forms that have previously been downloaded by the PI or without the Department Chair's signature. 3. Amendments 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. You may attach additional information to the amendment form as necessary. Please note that a completed GUACUC application must be submitted with the amendment form when adding a new species. For further guidance please see Guidelines for Amendment vs New Protocol Submission 4. Annual Renewals (1st and 2nd Year Reviews) On the first and second anniversary of your protocol, the GUACUC 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 GUACUC 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. 5. Three-Year Resubmission of a Protocol (effective July 1, 2006, required every three years) Beginning in July 2008, the GUACUC office will send you an "Expiration and Resubmission Notice" form five months prior to the 3-year expiration of your protocol. This form must be returned upon receipt indicating whether or not you intend to resubmit. The rewritten protocol needs to be received in the GUACUC office by the DUE DATE noted on the form. After final approval the old number is inactivated and the new number is used to track the protocol. Failure to respond to the Expiration Notice will result in the inactivation of the protocol. All animals in the DCM must be assigned to active approved protocols. Extensions to expired protocols are no longer permitted by regulatory agencies 6. Submission Deadline The GUACUC meets on the third Tuesday of the month. To be considered at the monthly meeting, the original and two copies of the GUACUC proposal must be received in the GUACUC Office in Basic Science Building, Room 247 by 5 pm of the last Tuesday of each month. Any proposals received after this time will not be reviewed until the following meeting. Please consult the GUACUC Meeting Schedule page for the upcoming deadlines and meetings. 7. Additional Information The Principal Investigator is responsible for providing sufficient information to the GUACUC 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 GUACUC proposal, additional information or clarification may be requested from the Principal Investigator in an effort to facilitate the approval process. 8. Designated Member Review The GUACUC approved the use of Designated Review on December 20, 2005. When an investigator makes a request for Designated Review of a GUACUC protocol or amendment, the initial request needs to be sent to the Chair for determination whether review other than full board is appropriate. If the Chair determines that Designated Review is possible, he/she assigns the specific reviewers to include a Veterinarian. A copy of the complete protocol is posted to the GUACUC Committee Member Blackboard site and email notification is sent to all board members that the protocol for designated review is posted on Blackboard. A ballot will accompany this email that the member completes whether they agree with Designated Review or whether they want the protocol to be reviewed by the full board. After 7 days posting on Blackboard, if NO GUACUC member votes to send to full board AND at least 10 members have submitted their reply agreeing to Designated Review, the Designated Reviewers will determine if the protocol or amendment is approvable or whether it needs review by the full board. The date of Designated Review approval is the approval date. 9. Committee Action Principal Investigators are notified in writing of the GUACUC 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. 10. Contingency Response Before a proposal can receive full approval status, responses to any contingencies voiced by the GUACUC must be submitted by the Principal Investigator within 60 days of the contingency letter, or the proposal will be administratively inactivated. 11. Reporting Responsibilities The Principal Investigator is required to report any adverse developments to the Divison of Comparative Medicine veterinary staff and must request permission from the GUACUC to modify any aspect of the approved GUACUC proposal by submission of an amended application specifying the changes intended. In addition, a Principal Investigator who whishes 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). 12. Protocol Status Any questions regarding the status of a GUACUC protocol (whether pending or approved) should be directed to the GUACUC office. Please contact Sally Tyree-Brumley, GUACUC Administrator, by phone on 202.687.2164, email sbt25@georgetown.edu, or in person in Basic Science Building, Room 247.			Related Links: Clinical Trials Office Sponsored Programs University Counsel Internal Audit