Policy Number: 2005-028-v
Policy Title: 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

Author: J. Welter
ePublication Date: 8-5-2005
History: amended 10/2009