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Modification Review and Approval

Purpose

In order to comply with government regulations and to make the modification approval process as simple as possible for the Principal Investigators (PI), the IACUC has established a policy on modification review and approval.

Action

Any change to a protocol requires the PI to submit a modified protocol through InfoEd.  The IACUC office staff will review the modification criteria below to identify the appropriate review method.  If a submission is unclear, the review method will be determined in consultation with the IACUC Chair and Attending Veterinarian.

Table one below lists examples of significant and administrative modifications.  Table two below lists examples of modifications to be reviewed by various review methods.

IF THE MODIFICATION CAN BE REVIEWED ADMINISTRATIVELY, review will be conducted by IACUC staff.  Some administrative reviews may require additional veterinary consultation.

IF THE MODIFICATION IS SIGNIFICANT AND REQUIRES IACUC REVIEW, the submission will be reviewed according to federally recognized review processes; Full Committee Review (FCR), Designated Member Review (DMR), or Veterinary Verification and Consultation (VVC).

Full Committee Review:  If IACUC staff determines that the significant modification requires a full committee review, it will be processed as such.  The modification will be assigned appropriate reviewer(s) and will be reviewed by the full committee at a regularly convened meeting.

Designated Member Review:  If IACUC staff determine that the significant modification meets the criteria for a DMR review, it will be processed as such:

  1. Notification of the submission of the modification will be sent to the entire committee so that each member may make a determination of whether or not they wish to call for a full committee review of the modification.  The IACUC coordinator will generally allow a few days for this review; however, exceptional circumstances may warrant a shorter review time period.
  2. It is the responsibility of the IACUC members assigned to review the modification to do so by the assigned due date.
  3. The modification does not get reviewed at a regularly convened IACUC meeting.
  4. Documentation of the DMR review will be in the IACUC minutes.

Veterinary Verification and Consultation Review:  If IACUC staff determine that the significant modification meets the criteria for a VVC review, it will be processed as such:

  1. The modification request will be sent to the Attending Veterinarian for review.
  2. It is the responsibility of the AV assigned to review the modification to do so by the assigned due date.
  3. The modification does not get reviewed at a regularly convened IACUC meeting.
  4. Documentation of the VVC review will be in the IACUC minutes.

TABLE ONE: EXAMPLES OF SIGNIFICANT VS. ADMINISTRATIVE MODIFICATIONS

Requires IACUC review Requires administrative review
Change in study objectives Addition of personnel
Change in Principal Investigator Addition or deletion of funding sources
>100% increase in rodent animal numbers Addition or deletion of room locations
>25% increase in non-rodent animal numbers <100% increase in rodent animal numbers from the original approved number
Change from non-survival to survival surgery <25% increase in non-rodent animal numbers
Change resulting in greater pain, distress, or degree of invasiveness Addition of strains, including Tg/GT lines that have a known phenotype
Housing of animals in a location that is not previously approved
Any changes that have the potential to impact personnel safety
Changes in experimental procedures
Addition of experimental procedures
Change of species
Addition of strains with an unknown phenotype

TABLE TWO: SIGNIFICANT MODIFICATIONS- CRITERIA FOR FCR/DMR/VVC REVIEWS

Full Committee (FCR) Designated Member (DMR) Veterinarian (VVC)
Addition of major survival surgery Chage in study objectives Changes to anesthesia and analgesics
Addition of painful procedures Change in Principal Investigator Addition of non-invasive samples
Death as an Endpoint Housing of animals in a location that is not previously approved Euthanasia to any AVMA-approved method
Any exceptions to regulations Any changes that have the potential to impact personnel safety Addition of sample collection times
 Change in or addition of a new USDA-regulated species Change in or addition of new non-USDA-regulated species Addition of strains with an unknown phenotype
Addition of minor survival surgery

 

Effective Dates:       April 28, 2026 through December 31, 2027

Last Revised:            June 6, 2024

This policy has been approved by a majority vote of the IACUC Members