In response to the issues raised in this scenario, the Office of Laboratory Animal Welfare (OLAW) offers the following clarification and guidance:

OLAW has previously commented on a similar situation concerning administrative extension of an expired animal study protocol1. For animal activities funded by the Public Health Service (PHS), the PHS Policy on Humane Care and Use of Laboratory Animals (Policy; section IV.C.5.) states that “the IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1.-4. at least once every three years”2. In order to extend the project, the IACUC must carry out a complete review and approve the protocol either at a full committee meeting or by designated member review2. If a protocol expires, all animal activities conducted under that protocol must cease. Continuation of animal activities in the absence of a valid approval is a serious violation of both the PHS Policy and the terms and conditions of the grant3. These violations must be reported to OLAW and the funding component3. If the project is PHS-supported, funds may not be drawn from the grant for any animal activities during the expired period4.

If an approved research protocol expires and animals are held under a holding protocol under which no research work is done, then reporting is not required. Use of a holding protocol, though permissible, should be viewed as an emergency stopgap and should not be a regular practice. Institutions should have policies and procedures in place to ensure that protocols are reviewed in a timely fashion. By allowing the investigator to keep animals on a holding protocol for an extended period of time without a compelling reason, Great Eastern University's IACUC is encouraging disregard for its authority and oversight of the animal care and use program. The IACUC needs to carry out a comprehensive review of its policies and procedures and to communicate them clearly to all investigators.

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