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 Topaz.  This is sent to the IACUC office and the IACUC Administrator reviews the modification for processing.  The IACUC Administrator is responsible for determining if a modification is major (significant) or minor; however, the ultimate decision, should there be any questions, will lie with the IACUC Chair.

Table one below lists examples of modifications that would be considered minor or major (significant).  Table two below lists examples of modifications to be reviewed by various review methods.

IF THE MODIFICATION IS MINOR: Review of the submitted modification will be reviewed administratively for approval by an appropriate member of the IACUC.  If there are any questions regarding the assignment of an appropriate member, the IACUC Chair will review the modification.  No other review by the IACUC is required.

IF THE MODIFICATION IS MAJOR: The modification will be reviewed by the IACUC according to federally recognized review processes:  Full Committee Review (FCR), Designated Member Review (DMR), or Veterinary Verification and Consultation (VVC).  The IACUC Administrator is responsible for determining a review type; however, the ultimate decision, should there be any questions, will lie with the IACUC Chair.

Full Committee Review:  If the IACUC Administrator 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 the IACUC Administrator determines 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 Administrator will generally allow a few days for this review; however, exceptional circumstances may warrant a shorter review time period.
  2. The modification will remain on the agenda covering the request period for documentation purposes.
  3. It is the responsibility of the IACUC member(s) assigned to review the modification to do so by the assigned due date.
  4. The modification does not get reviewed at a regularly convened IACUC meeting.

Veterinary Verification and Consultation Review:  If the IACUC Administrator determines 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 (AV) for approval.  Certain circumstances may warrant that the request also be reviewed by safety personnel (if there is an addition of the use of a hazardous chemical or biological agent).
  2. The modification will remain on the agenda covering the request period for documentation purposes.
  3. It is the responsibility of the AV assigned to review the modification to do so by the assigned due date.
  4. The modification does not get reviewed at a regularly convened IACUC meeting.

The initial determination of modification requests to be minor or major (significant) and the review type (FCR, DMR, or VVC) will be performed by the IACUC Administrator.  Should there be any questions regarding whether or not a modification is considered to be minor or major (significant), it will be decided by the IACUC Chair.  Should there be any questions on the assignment of a review process for major (significant) changes, it will be decided by the IACUC Chair.

TABLE ONE:  Examples of Major (Significant) vs. Minor Modifications

Major- Requires IACUC Review Minor- Handled Administratively
Change in purpose or aim of a study Addition of qualified personnel (other than PI)
Change in Principal Investigator Addition or deletion of funding sources
100% or greater increase in rodent animal numbers Addition or deletion of room locations
25% or greater increase in non-rodent animal numbers <100% increase in rodent animal numbers
Addition of survival surgery <25% increase in non-rodent animal numbers
Addition of painful procedure Need to repeat an experiment
Housing of animals in a location that is not part of the animal program overseen by the IACUC Addition of animal strains, including transgenic or gene targeted lines
Any changes that have the potential to impact personnel safety
Changes in experimental procedures
Addition of experimental procedures
Addition of species

TABLE TWO:  Major Modifications- Criteria for FCR/MDR/VVC Reviews

Full Committee (FCR) Designated Member (DMR) Veterinarian (VVC)
Addition of major survival surgery Chage in purpose or specific aim of a study Changes to anesthesia and analgesia
Addition of painful procedures Change in Principal Investigator Addition of non-invasive sample collections
Death as an Endpoint Housing of animals in a location that is not part of the animal program overseen by the IACUC Addition of experimental substances (note:  may require safety review)
Any exceptions to regulations or standards Any changes that have the potential to impact personnel safety Euthanasia to any AVMA-approved method
 Addition of a new USDA-regulated species Addition of new non-USDA-regulated species Addition of sample collection times
Addition of minor survival surgery  Addition of experimental procedures that will not result in pain/distress to the animals (e.g., pain category B or C procedures)

 

Effective Dates:    December 6, 2018 thru December 31, 2021