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: To provide guidance to UW-Madison PIs and ACUCs on the information that should be included in animal use protocols in order to protect animal health and welfare.

Policy: If a PI proposes to use a compound in a species in which the compound has never been used before, the following should be provided to the ACUC in the protocol:

• Any information about safety, toxicity, and efficacy in at least two other species. If this information is proprietary, a letter from the drug company supplying the substance must be provided to the ACUC indicating what, if any, toxic effects they have observed with the compound at doses to be used in the protocol.
• Specific information about how the adverse effects will be monitored:
  • The timing and frequency of monitoring activity
  • Behaviors and/or biochemical or metabolic changes that will be monitored
• Specific endpoints, such as (but not limited to):
  • Impaired ambulation
  • Seizures
  • Rapid weight loss
  • Labored breathing
  • Impaired mentation
  • Anaphylaxis

If no such data is available, a pilot study should be done, which must be included in an approved animal use protocol, to ascertain if acute toxicity exists.

Prepared by: J. Welter

Reference Minutes: 07/08/2005, 08/05/2005