Protocol Renewal & Expiration
The University signs an Assurance with the Office of Laboratory Animal Welfare (OLAW) that states that all research, regardless of funding source, will be conducted following the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals.
This policy prohibits conducting ANY animal activities (procurement, breeding, housing, and/or use) or expenditure of federal funds for animal activities (including the purchase of animals and costs for breeding, housing, or other use) after a protocol has expired.
Accordingly, all protocols undergo de novo review every three years. Any activities conducted after a protocol has expired are considered to be in serious violation of the PHS Policy. These violations are reported to the U-M Institutional Official and may also require a report to OLAW.
To ensure compliance PRIOR to a protocol’s expiration,
the Principal Investigator (PI) and laboratory contact(s):
- Will be notified that the protocol is expiring and due for renewal. This notification will include a deadline for renewal submission and steps to remain compliant with U-M policy and federal regulations
- Will be provided the necessary steps to transfer remaining housed animals from an expiring protocol
- May euthanize remaining animals or will be required to transfer animals to the U-M Holding Protocol if the PI’s renewal protocol will not be approved prior to the expiration date of the protocol.
To ensure compliance AT a protocol’s expiration, the PI and laboratory contact(s) will be notified:
- When the protocol has expired
- That no further housing or experimental manipulations will be permitted under the expired protocol.
Please note that, per National Institutes of Health (NIH) policy, any charges to NIH awards for animal activities conducted during lapses of IACUC approval must be transferred to a non-federal funding source. In cases of protocol expiration prior to approval of a renewal protocol, it is the PI’s responsibility to ensure that animals are transferred to the U-M Holding Protocol.
Any failure to remove animals from an expiring protocol will be reported to the IACUC as an incident of non-compliance.
The U-M Holding Protocol has been created to provide a mechanism for holding animals when the PI does not have a currently approved IACUC protocol (e.g., protocol expiration without renewal approval, protocol suspension due to non-compliance, incoming investigators in the process of receiving IACUC approval).
To ensure compliance while on the U-M Holding Protocol, the PI and laboratory personnel:
- Must follow the Policy for the Use of the U-M Holding Protocol
- Must NOT handle the animals without documented permission
- Must utilize the personnel chosen by the U-M Attending Veterinarian or designee for husbandry and veterinary care
- May experience limited access to animal facilities
As part of being placed on a U-M Holding Protocol, the PI and laboratory personnel:
- Will be responsible for charges incurred for U-M Holding Protocol animal husbandry and veterinary care
- Will be responsible for assigning charges incurred to appropriate, non-sponsored funds
- Will be responsible for transferring animals to the PI’s approved protocol via a transfer request in eRAM
Questions?
Additional questions or concerns should be directed to your Research Compliance Associate in the Animal Care & Use Office. General questions can also be submitted to acuoffice@umich.edu or (734) 763-8028.