The USDA Animal Welfare Act Regulations (AWARs) and the Public Health Service Policy on the Humane Care and Use of Laboratory Animals (PHS Policy) stipulate that the ARC must conduct continuing reviews of previously approved research activities at least once every three years.[1]
Conducting research activities[2], under a protocol that has expired and not yet been re-approved by the ARC constitutes a serious violation of both the AWARs and PHS Policy and is therefore unacceptable under any circumstance.
At ninety (90), sixty (60), and thirty (30) days prior to the protocol expiration date, the Principal Investigator (PI) and any PI proxies assigned to the protocol will receive email notification of the upcoming expiration, with instructions for the continuing review process. Upon expiration of an approved animal protocol, the PI and proxies will be notified by email that all animal-related research activities covered by that protocol must be stopped in accordance with PHS and ARC Policy. To prevent lapses in protocol coverage, animals attached to the expired protocol, whether naïve or part of an active experiment, will automatically be transferred to the UCLA Animal Holding Protocol (ARC #2008-076) and care provided per DLAM SOPs or as described in the holding protocol. Contact the DLAM Clinical Veterinarian to discuss this transfer and continued care of animals during the lapse in protocol approval. Contact the DLAM Billing Manager at ext. 5-5540 to provide a recharge ID number to be used while animals are on the holding protocol. Animals assigned to the Holding Protocol will be returned to the PI’s protocol only after continuing approval is obtained.
PHS Funded Studies: The Office of Management and Budget Cost Principles and the NIH Grants Policy Statement (NIHGPS) do not permit use of contract or grant funds for the conduct of animal activities during a lapse in ARC approval or suspension of animal activities[3]. Permission must be obtained from the relevant grant program officer to use federal funds to pay per diems during a lapse in ARC approval, including for animals placed on the DLAM holding protocol.
[1] USDA AWARs § 2.31(d)(5) and PHS Policy IV.C.5
[2] "Research activities" includes any experimental manipulations (e.g., surgery, collection of blood, collection of tissue for genotyping, behavioral testing), special housing conditions (e.g., special diet or feeding/watering schedule, special light cycle, special cage changing cycle), collection of tissues at euthanasia for postmortem analysis, setting up breeding pairs, or any other collection of data from animals under that protocol.
[3] NIH Guidance Document NOT-OD-07-044
Approved 3/14/16; Revised 8/13/18, 2/27/23
Replaces ARC Policy on Treatment and Use of Animals under Expired or Suspended Protocols, Approved 3/28/05; Revised 3/1/10, 8/13/12