The IACUC must review all proposed animal use protocols before any animal research can be performed within the CRI research and animal facilities. In reviewing the protocol, the IACUC will consider whether the protocol contains all required management and regulatory elements as defined by the Animal Use Policy and Laboratory Animal Program Description. The IACUC will determine if the proposal contains the following information: a justification of why the treatment/condition is scientifically necessary; a statement demonstrating that the PI performed a thorough search of alternatives to the potentially painful procedures; and standards and practices for pain management, adjuvant use, humane end-point determination, etc. At the same time, the OHS Committee will review and discuss safety matters involving the use of chemical, biohazardous and/or radiological agents or materials in animal protocols to ensure the investigator has appropriately planned to reduce or eliminate the exposure to potentially hazardous agents. After determination by the IACUC that the animal use protocol is complete, the protocol is recommended to the IO (or Vice-President for Research and Academic Affairs in the case that the IO is part of the research team on the protocol) for final approval. After official approval, the IACUC Chair will inform the PI that the study may begin. Links 1. LAC-IACUC Form 500 PROTOCOL COVER SHEET2. LAC-IACUC Form 501 IACUC memorandum to...

Proposed modifications to an approved protocol must be reviewed by the IACUC, and receive final approval from the IO (or Vice-president for Research and Academic Affairs in the case that the IO is part of the research team on the protocol) prior to start of the requested study. Modifications to animal protocols may be classified as minor or major. Minor modifications may include changing doses or routes of administration of a drug, and recording or measuring additional variables in the whole animals that are no more invasive than procedures currently approved under the protocol, and that do not increase the pain category of the protocol. Major modifications are those that require a change in the scientific direction of a protocol, e.g. requiring a greater than 10% increase in the number of test animals, changes in the species of the animals approved on the original protocol, changes in pain severity rating, increases in biohazard level on the protocol, and the addition of multiple minor modifications, or a change in the PI. A new PI for a previously approved and active protocol must submit a training statement with his/her request and a signed assurance statement. The process for reviewing/approving protocol amendments is the same as for reviewing a new protocol. Links 1. LAC-IACUC Form 500 PROTOCOL COVER SHEET2....

Annual review and approval by the CRI-IACUC is required for each protocol to remain active through the approved period (3 years). Annual reviews are generally due at the end of each year and cover the previous fiscal year. Amendments should be incorporated into the body of the text and required literature searches must be updated by the Principle Investigator (PI) via an Annual Review of Animal Protocol (IACUC form 505) submitted to the IACUC Administrator for IACUC review and approval. If animal work is to continue on a protocol after the three-year period, the protocol is required to be rewritten completely and all information updated prior to a full IACUC review. In addition, post approval monitoring (PAM) is randomly conducted by means of: a) Additional reviews conducted as appropriate if and deviations or violations are detected/reported. b) Routine observation of animals by animal care personnel. c) Veterinary care or observation by the Attending Veterinarian.