Monitoring Animals at Risk of Developing Protocol-Related Morbidity or Mortality

Reference(s):

• Guide for the Care and Use of Laboratory Animals, NRC, 1996
• Animal Welfare Regulations, 9 CFR, chapter I, subchapter A

Policy:

Implementation:

1. Animal Care and Use Protocol Review - During the protocol review process, the IACUC will assess the risk of animal morbidity and mortality that may result from the proposed procedures. Protocols that are judged to involve significant risk to the animals will be designated as “High Risk”.

2. Role of the Veterinary Staff and Animal Care Unit:
   1. Identification of Animals Assigned to High Risk Protocols
      Animals assigned to High Risk protocols must be conspicuously identified as such, using a method approved by the DAR. The local animal care unit will be responsible for providing such identification.

   2. Veterinary Monitoring and Intervention
      All animals are observed at least once daily by the animal care staff. Once an animal assigned to a High Risk protocol develops clinical morbidity, the veterinary staff will be notified and it will be subjected to a specific clinical observation program designed and conducted by the veterinary (professional and paraprofessional) staff. Based on the clinical condition of the animal(s) and the end-points described in the approved protocol, the veterinary staff will determine appropriate on-going monitoring and intervention. In the event that veterinary intervention is necessary, reasonable effort will be made to consult with the principal investigator or his/her designee prior to intervention. In urgent cases when the responsible investigative staff is not available in a reasonable amount of time, the veterinary staff has the authority to implement appropriate intervention, which may include medical or surgical therapy or euthanasia.

3. Role of the Investigator - It is important to note that veterinary monitoring is not intended to relieve the investigator of his/her responsibility for monitoring his/her animals at the frequency described in the protocol and approved by the IACUC. Rather, it will independently augment the investigators' activities and serve as a means for improving communication between the IACUC, the veterinary staff, and the investigators. The investigator will continue to be required to provide adequate monitoring of animals assigned to his/her protocol; a description of the monitoring must be included in the protocol.

4. Documentation of Monitoring - The research staff and the veterinary staff will record observations pertaining to this policy on a form developed by the DAR in consultation with the animal care unit supervisors/managers. The animal care staff may also use this form to record their daily observations, as desired. This form is the property of the IACUC and will be available with the animals at all times. It will be filed with the protocol at the termination of the study.

5. IACUC Oversight - The veterinary staff will report on a regular basis to the IACUC the status of animals assigned to High Risk protocols. The IACUC will review this plan on a semiannual basis.