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 identifythe appropriate review method.  If a sumission 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 office staff.  Some admnistrative reveiws may require additional veterinary consultation.

IF THE MODIFICATION IS SIGNFICATN 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 the IACUC office 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 the IACUC office staff 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 office staff 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. 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 the IACUC office staff 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 for review.
2. It is the responsibility of the AV assigned to review the modification to do so by the assigned date.
3. The modification does not get reviewed at a regularly convened IACUC meeting.
4. Documentation of the VVC reveiw will be in the IACUC minutes.

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

Major- Requires IACUC Review	Minor- Handled Administratively
Change in study objectives	Addition of personnel
Change in Principal Investigator	Addition or deletion of funding sources
100% or greater increase in rodent animal numbers	Addition or deletion of room locations previously approved
25% or greater 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	Need to repeat an experiment
Housing of animals in a location not previoiusly approved	Addition of animal strains, including transgenic or gene targeted lines, that have a known phenotype
Any changes that have the potential to impact personnel safety
Changes in experimental procedures
Addition of experimental procedures
Addition of species
Addition of strains with an unknown phenotype

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 study objectives	Changes to anesthesia and analgesics
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 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