Animal Care & Use

Amending an Existing Protocol Bloomington

Minor Amendments

Minor amendments are reviewed weekly at the Designated Member Review meeting.

Examples of changes considered to be minor include:

  • Change in animal genetic background or strain (where change does not impact animal care);
    • New transgenic rodent strains may be added only if the project already includes transgenic rodents, and the new strain does not involve a) any pathogenic vector, b) the expression of any biotoxin, or c) any gene that would require more than Biosafety Level (BSL) 1 containment.
  • Change in sex or age of animals;
  • Change in number of animals where the change is limited to additions of <10% of the originally approved for species for mice of the genus Mus and rats of the genus Rattus that are bred for use in research only.
  • Change in animal source, animal care facility, housing unit or field site
  • Change in administration of experiment/treatment as it relates to timing, dose, route of administration and/or specific chemical composition
  • Refinement* of previously approved procedure for this study (change may not alter the invasiveness of the procedure, specific objective(s), or scientific rationale)

*Refinement as defined here follows the External Link USDA Policy Statement 12 and refers specifically to a change in a procedure that lessens or eliminates pain or distress in the animal.