In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:

In the described scenario, the PI's approved research protocol expired and a period of time passed before the animals were transferred to an approved holding protocol. APHIS and OLAW consider the intervening period as a lapse in IACUC approval. It is very important for IACUCs to have policies and procedures that prevent such lapses.

When IACUC approval expires, the research protocol is no longer valid. Continuation of research activities beyond the protocol expiration is a violation of both the Animal Welfare Regulations (AWRs)1 and the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy)2. This noncompliance with PHS Policy must be promptly reported to OLAW3. Additionally, the Office of Management and Budget Cost Principles and the NIH Grants Policy Statement do not permit charges to grant awards for the conduct of animal activities after IACUC approval has lapsed; such charges are a violation of the terms and conditions of the grant award and must be reported to the NIH Institute or Center supporting the award4. (NIH expects grantees to continue to maintain and care for animals. NIH funding components may allow expenditure of grant funds for such maintenance and care on a case-by-case basis4.)

Specifically, in this scenario, the IACUC should develop a practice for handling protocols due for annual or triennial review prior to the expiration of the protocol.

IACUCs are empowered with the flexibility to develop methods that meet the needs of the institution. One option the IACUC could consider is to place the animals on an approved holding protocol prior to the expiration of the research protocol. Local institutional procedures may require the use of a holding protocol to ensure that the appropriate funding source is charged for maintaining the animals. Alternatively, the IACUC could choose to maintain the animals using IACUC-approved standard operating procedures (SOPs) for housing and routine animal care. Although the AWRs and the PHS Policy do not require holding protocols or SOPs, both options are permitted and are acceptable to APHIS and OLAW.

Additionally in the described scenario, the PI of the Great Eastern animal holding protocol is the entire IACUC, making it unclear who is responsible for the animals. APHIS and OLAW concur that the practice of appointing the entire IACUC as PI is not recommended. The Guide for the Care and Use of Laboratory Animals describes the PI as the individual “who has precise knowledge of both the objectives of the study and the proposed model”5. Should an institution choose to maintain the animals under a holding protocol, the PI position would be best served by an individual who takes responsibility for the animals, such as a veterinarian or animal facility manager, rather than the entire IACUC. Similarly, an SOP for holding animals should designate an individual with primary responsibility for the animals.

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