University of Wisconsin-Madison

Policy Number: 2005-028 [PDF]

Adoption Date: 8-5-2005

Effective Date: 8-5-2005

Expiration Date: ongoing

Review Date: Annually

Policy Regarding Novel Substances Tested in Laboratory Animals

Purpose: A novel substance is any chemical entity that has never been tested, is in the early stages of animal testing, or is a previously characterized substance administered in a novel way. This policy provides guidance to UW-Madison PIs and ACUCs on the information that must be included in animal use protocols in order to protect animal health and welfare and promote scientific rigor.

Policy: If a PI proposes to use a compound in animals that has never been tested in that species, the following information must be provided to the ACUC in the animal use protocol:

• A synopsis of any available in vitro or in vivo data including pharmacological and toxicological actions of this or related compounds
• A brief description of the class of compound, including mechanism of action (if known)
• A complete description of dosage, route of administration, how long compound will be administered, the intervals by which dosages will be increased/decreased (if applicable), and the rationale for increasing/decreasing dosages
• The plan for monitoring of animals for adverse events after compound administration, including:
  • Frequency of monitoring
    • More frequent especially if there is a potential for acute toxicity
    • Less frequent after animal responses are better known
  • Identification of staff performing the monitoring
  • How monitoring will be documented
  • Behavioral signs of pain and distress that will be monitored
  • Objective monitoring parameters (e.g., biochemical or metabolic changes)
  • Plans for treating animals for toxicity, if indicated
• Specific humane endpoints, such as (but not limited to):
  • Impaired ambulation
  • Seizures
  • Rapid weight loss (usually due to dehydration)
  • Labored breathing
  • Impaired mentation
  • Anaphylaxis
• Study endpoints
• Potential occupational health and safety concerns for laboratory staff, animal caretakers, veterinarians, etc., during and after administration to animals, including handling of carcasses, bedding, and caging

Prepared by: J. Welter

Reference Minutes: 07/08/2005, 08/05/2005, 10/9/2009