Medford Policy on Review of Amendments to Approved Protocols
Approval Date: October 3, 2018
The Institutional Animal Care and Use Committee (IACUC) has a responsibility to review and approve all changes to previously approved protocols. Amendments are considered either Significant or Minor and the required method of review is based on that classification.
Amendments are considered significant if they include changes that have the potential to negatively impact animal welfare or changes in personnel safety. Significant changes must be approved by one of the two valid methods of IACUC review: (1) Full Committee Review (FCR) by a convened quorum of the members of the IACUC, or (2) Expedited Review (ER) by a subcommittee of the IACUC. The IACUC review procedures are detailed in the “Policy on IACUC Review Procedures.”
The following changes are considered significant:
Changes from non-survival to survival surgery;
Changes resulting in greater pain, distress, or degree of invasiveness;
Changes in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;
Change in species;
Changes in study objectives;
Departures from the Guide for the Care and Use of Laboratory Animals;
Change in Principal Investigator;
Changes that impact personnel safety.
Minor amendments include other less substantial protocol changes that do not fall under the significant category. For the review of minor amendments, at least two IACUC reviewers are selected by the IACUC Chair (or Vice-Chair in the absence of the Chair). The reviewers have the authority to approve, require modification in order to secure approval, or call for Full Committee Review. If any modifications are requested by the reviewers, they are sent back in writing to the Principal Investigator. The revision is then submitted back to the reviewers. This process continues until approval can be obtained. At any time, the reviewers may call for Full Committee Review of the minor amendment. The IACUC is notified of all amendment approvals at the next convened meeting.
Public Health Service Policy, 2002. NIH OLAW. Section IV, B. Functions of the Institutional Animal Care and Use Committee. P.13.
Animal Welfare Act and Animal Welfare Regulations, 2002. USDA APHIS. Subpart C. 2.31. Institutional Animal Care and Use Committee. P.34
Office of Extramural Research Revised Guidance Regarding IACUC Approval of Changes in Personnel Involved in Animal Activities, 2003. NIH OLAW. NOT-OD-03-046.