IACUC Amendment Guidance


 Amendment Significance Policy

An Amendment is any change to the ongoing approved IACUC protocol. All changes to IACUC approved activities must be approved prior to implementation. Changes to approved animal activities will meet the requirements described in the PHS Policy (IV.C.1.a-g.) and Animal Welfare Regulations (9 CFR 2.31 (d) (1) (i)- (iv)).

Amendments must include the following components:

Significant changes include, but are not limited to, changes that have, or have the potential to have, a negative impact on animal welfare. IACUC approval of significant changes to previously approved animal activities is granted after full committee review (FCR) or designated member review (DMR).

Significant changes described below, must be approved by either FCR or DMR, including changes: 

  • from nonsurvival to survival surgery;

  • resulting in greater pain, distress, or degree of invasiveness;

  • in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;

  • in species;

  • in study objectives;

  • in Principal Investigator (PI); and

  • that impact personnel safety.


Changes described below, may be handled administratively in consultation with a veterinarian authorized by the IACUC. The veterinarian is not conducting DMR, but is serving as a subject matter expert. Consultation with the veterinarian will be documented. The veterinarian may refer any request to the IACUC for review for any reason and must refer any request that does not meet the parameters of the IACUC-reviewed and -approved policies. This includes changes in:

  • anesthesia, analgesia, sedation, or experimental substances;

  • euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals; and

  • duration, frequency, type, or number of procedures performed on an animal.


Changes that may be handled administratively (without the use of DMR or FCR) include, but are not limited to:


  •  a change in personnel, other than the PI; and

  • the addition of a funding source which covers the scope of work and procedures already approved on the existing protocol;

  • changes in animal housing location that are part of the animal program overseen by the IACUC;

  • an increase of less than 10% in previously approved numbers of mice and/or rats