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The Institutional Animal Care and Use Committee (IACUC) meets once a month to approve the action taken during the previous month by the committee when reviewing project applications (protocols) prepared by investigators. Principal investigators and course directors must obtain approval from the IACUC before initiating any research, testing, or instructional project involving the use of vertebrate animals (IACUC Policy No. 01). An application to use animals, called an Animal Use Form (AUF) must be submitted for IACUC review. Each committee member reviews every form. Each week AUFs received by Wednesday at noon are mailed to every committee member on Thursday morning. Any questions or comments are to be returned to the IACUC office by the following Thursday by 5:00 p.m. At the conclusion of the review period, the IACUC Coordinator compiles all the individual questions and /or comments so the IACUC Chairperson can review and consolidate the questions which then go to the investigator. Upon receiving the researcher responses, the IACUC Coordinator confirms that the committee member's questions have been answered. The responses are then sent to the committee for review. There is a three day window for the review process. If questions presented to the principal investigator are not adequately addressed, or if the PI's responses create new questions, the process continues. Approval is granted after all the questions have been answered and a majority of the committee favor approval. Any IACUC member can call for a full committee review which takes the form out of the review process and initiates review at the next convened committee meeting. At each meeting, the committee examines the log of the action taken on all forms that had, or are being, reviewed since the last meeting. The committee then votes approval of the action taken. There is no expedited review process. In some cases, the protocol may be approved with a stipulation (e.g., asks a veterinarian to observe and send a written report to the IACUC). An approval letter is sent to the Principal Investigator, with copies to the department chair and the Contract and Grant Office. In addition, if requested, an approval letter is also sent to the funding agency. Protocols are approved for a maximum of three years. Each year, three months in advance of the expiration date, principal investigators are sent and are required to complete, sign, and return an Annual Review Letter. The investigator must indicate that the project is still ongoing; whether changes have been made in the research (an amendment must be attached to the renewal letter if changes are proposed); the project has been completed, or the project will not be done. In the case of a form having reached the end of the three-year period, a new AUF must be submitted and approved before the current AUF approval expires. All AUFs are entered into a Protocol Tracking System. The system matches the PI with the AUF number on the animal purchase request. The number and species must correspond to those specified on that AUF. As orders are placed, animal numbers are deducted from the total. Two reports are generated weekly: 1) At/Over Animals Allowed; 2) Approaching End of Animal Numbers. When the number of animals used reaches 80% of the number approved, a report is generated and a letter is sent to the PI. If the PI will be using additional animals, he/she must file an amendment. When the limit is reached, the PI is advised that no animals can be ordered until an amendment has been approved. Any significant change to the protocol requires filing of an amendment. Approval of amendments is done by the Chairperson with additional review by any other committee members or ORCBS, at the chairperson's discretion. Reviews are to be done on an active AUF. Investigators add information for the amendment to the currently approved AUF. Pages that are affected by this amendment are sent to the IACUC office. The IACUC Coordinator retrieves the corresponding information from the active AUF, and sends that with the amended questions to the IACUC Chairperson. Amendments can take up to seven days for review and approval. The IACUC has
full authority to approve, disapprove, or require modifications
in protocols as deemed appropriate. In all cases, the committee
has sole responsibility for the final decision. The IACUC applies
the same protocol review process to all animal studies and proposals
regardless of species, size or source of funding. The IACUC reviews
projects as it relates to appropriate animal selection, care and
use. |
