This document provides guidance for animal use protocols that administer novel compounds. The goal is to increase flexibility and reduce administrative burden associated with novel compounds.
A novel compound is defined as any chemical entity that has never been tested in animals, or is in preliminary stages of testing, or is a previously characterized substance that is being administered in a novel way.
The specific name(s) and structure(s) of novel compounds are not required in protocol applications, as long as the following information is provided:
A description of the general chemical or therapeutic class
The dose, route, frequency and duration of experimental administrations.
A plan for monitoring animals after compound administration
Subsequent amendments for related compounds will not be necessary unless:
changes to adverse effects and/or monitoring are indicated
a change in pain/distress category is needed
a new solvent/diluent/vehicle is necessary that is not pre-approved (see list below)
Plan for monitoring
When working with novel compounds, the Principal Investigator (PI) must provide a plan for monitoring adverse effects. This should include signs of pain and distress relevant to the species, any anticipated signs based on known information, and frequency of monitoring.
If the investigator has previous data from animals administered a maximal dose, and no adverse effects were identified, routine monitoring is warranted.
If adverse effects have previously been found or are unknown, monitoring should be more frequent, to be determined on a case by case basis.
Pain and distress category
Animals administered novel compounds will be placed in Category C, unless proposed procedures or anticipated toxicity dictate otherwise. As information is acquired about the compound, the category may be changed via submission of an amendment.
Animal number justification
The PI must be able to provide the following:
The justification for the number of animals needed for one complete experiment (i.e. sufficient to test one novel compound with all the time points, controls, etc.).
The best estimate of the number of novel compounds expected over the duration of the protocol.
Solvents/diluents/vehicles for use with Novel Compounds
The following list of solvents, diluents, or vehicles do not need to be specified in the protocol when used with novel compounds.
Sodium Chloride 0.9 %
Phosphate Buffered Saline (PBS)
Lactated Ringers Solution
Other solvents, diluents, and/or vehicles will require specific IACUC approval in order to assess any potential risks. It’s recommended to include a range of different solvents, diluents, and/or vehicles during the initial submission to allow flexibility during the lifetime of the protocol.