IACUC Protocol Amendments

In accordance with the Policy on Review of Amendments to Approved Protocols, any changes to a protocol must be approved by the IACUC prior to implementation. The following significant changes require review by either Full Committee Review (FCR) of a convened quorum of the members of the IACUC or Designated Member Review (DMR) after all the IACUC members have been given an opportunity to determine if a review by subcommittee is appropriate.

  • from non-survival 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);
  • that impact personnel safety;
  • increase in animals > 50% the number originally approved

Veterinary Verification and Consultation (VVC)

Some changes may be handled by a process referred to as Veterinary Verification and Consultation (VVC). For this process IACUC approved guidance documents may be used for the administrative handling of some changes. New procedures are not eligible for VVC and must be reviewed by FCR or ER.

VVC-Eligible Changes:

  • Changes in anesthesia, analgesia, sedation (including agent, dose, frequency, or route)
  • Changes in experimental substances (including dose, frequency, or route)

The substance itself may be changed if it is within a similar class to what was included in the original protocol (including vehicles, solvents, diluents, chemotherapeutics, antibiotics, hormones, etc.)

  • Changes in duration, frequency, or number of approved procedures

For some procedures, different variations of the procedure can be approved (e.g. blood collection or genotyping methods) as long as it is described in an IACUC-approved guidance document, included below.

Administrative Changes:

The IACUC may administratively handle the following, less substantial, changes that do not fall under the above categories:

  1. Increase in animals < 50% the number approved in the original protocol, given:
    • The original rationale for the number of animals supports the requested increase.
    • Additional animal numbers will be added via the Amendment Form and the PI will be notified that the increase has been added to the approved protocol.
    • If the conditions are not met or are ambiguous, IACUC staff have the authority to refer the amendment to the IACUC for FCR or DMR.
  2. Personnel changes (excluding changes in PI)
  3. Location changes to areas already part of the animal program overseen by the IACUC.

To notify the Committee of a proposed change to an Approved protocol, complete and submit a Protocol Amendment form.

*A pre-review by the IACUC office staff is strongly suggested for both the submission of protocols and amendments. This often saves time and work for the investigator.*

Change in Principal Investigator Amendment

It may become necessary to transfer an approved protocol to a new Principal Investigator. This transfer must be Approved by Full Committee Review or Designated Member Review. To notify the Committee of a proposed change in Principal Investigator, submit the Change in PI form  to IACUC-office@tufts.edu.

Change in Location Amendment

The removal of any live animal from the animal facility must be described and justified in an approved IACUC protocol, amendment, or Supplement L. The IACUC office will verify which of the review methods below is required.

  • If a location needs to be added and this location is already included in the current animal program, then it can be administratively approved.
  • If a location needs to be added that is not included in the current animal program it must be approved by a valid IACUC review method.