Federal and university policies require that use of animals in research and teaching activities conducted at UW-Madison be reviewed and approved by one of the campus Institutional Animal Care and Use Committees (IACUCs) before procedures are initiated.
To this end, investigators must submit an animal care and use protocol that contains a clear and comprehensive description of the proposed studies, a detailed accounting of experimental procedures, and a justification for use of animals.
Unlike a grant application, which can be modified at the discretion of the investigator, an animal use protocol is considered a contractual agreement between the investigator and the IACUC. Modification of any element of an IACUC-approved protocol without IACUC review and approval of the specific change constitutes a protocol violation.
There are serious consequences for protocol violations. Investigators, departments, schools, and colleges can lose funding and the university could lose its USDA registration, preventing all UW-Madison investigators from working with animals in any capacity.
Common protocol violations cited by USDA inspectors and the Office of Laboratory Animal Welfare (OLAW) include:
- using more animals than approved by the IACUC
- changing species or strains used without IACUC approval
- performing surgery or other procedures not described in the protocol
- performing more surgeries than approved by the IACUC
- repairing or replacing implants or performing surgical repairs if not approved by the IACUC
- providing medical care for sick or injured animals without consulting an attending veterinarian
- altering diet for experimental purposes without IACUC approval
- collecting blood or tissue samples not specified in the approved protocol
- collecting more blood or tissue than described in the protocol or using an altered collection schedule
- changing the type or dose of drug administered (unless approved by a campus veterinarian for clinical reasons)
- failing to conduct preprocedure blood panels described in the protocol
- failing to adhere to endpoints defined in the approved protocol
- failing to document postsurgical or postanesthesia monitoring
- conducting pilot studies without IACUC approval
- failing to monitor animals or make observations as specified in the approved protocol
- restraining an animal for periods exceeding those approved by the IACUC
- involving personnel not listed on the protocol
When a violation occurs
- The IACUC investigates the alleged violation.
- If the committee determines a violation has occurred, a letter is sent to the investigator regarding the violation; a written response is required. The response is reviewed, and will be discussed with the IACUC and the All Campus Animal Care Planning and Advisory Committee.
- If the investigator’s response is deemed inadequate, the IACUC may require training or retraining for research staff, require changes to procedures, or suspend the protocol or revoke animal user privileges from the PI.
- If the protocol is suspended, the investigator is informed of the suspension and is barred from ordering animals or performing experiments until IACUC-mandated requirements for reinstatement are met to the Committee's satisfaction.
- USDA, NIH, granting agencies, accrediting organizations and the investigator’s department chair can be informed of all protocol violations and suspensions. In many situations this notification is a regulatory or policy obligation.